Abaloparatide Works in ‘Ignored Population’: Men With Osteoporosis


The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, told Medscape Medical News.

Abaloparatide was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told Medscape Medical News, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”

Screen Men With Hypogonadism or Those Taking Steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very very good,” said Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density…That’s a group of people we’re ignoring still. They’re not getting diagnosed and they’re not getting treated.”

ATOM Study: Significant BMD Increases at Key Sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence compared with placebo, and also significantly greater reductions in nonvertebral fractures compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T-scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T-score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs 5.1%), nasopharyngitis (8.7% vs 7.6%), dizziness (8.7% vs 1.3%), and arthralgia (6.7% vs 1.3%), with abaloparatide vs placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

11 ways to increase bone density naturally


Low bone density can increase the risk of fracture. People can increase their bone density through strength training, dietary choices, weight management, and other strategies.

Bone density changes over time. Throughout childhood, adolescence, and early adulthood, the bones absorb nutrients and minerals, gaining strength.

However, as a person enters their late 20s, they reach their peak bone mass, meaning they will no longer gain bone density.

The bones may lose density as a person continues to age. After menopause, in particular, a person becomes susceptible to osteoporosis. Osteoporosis can weaken the bones so much that they can break easily.

This article lists 11 ways to naturally improve bone density, including information on whether it can be too late to increase bone density.

1. Weightlifting and strength training

Design by MNT; Photography by minamoto images/Stocksy & Alba Vitta/Stocksy

Studies show that weightlifting and strength training can help promote new bone growth and maintain existing bone structure.

A 2018 reviewTrusted Source of exercise and bone density in people with osteoporosis suggests that weight bearing aerobic exercise alone can limit bone mass loss, while strength and resistance exercises can increase muscle and bone mass density.

Review authors highlight that strength and resistance exercises are site-specific. They only increase muscle and bone mass density in areas the exercises stimulate.

Benefits of weight and strength training includeTrusted Source:

  • increased bone mineral density
  • increased bone size
  • protection against bone loss
  • improved balance and coordination
  • increased muscle mass

2. Eat more vegetables

Vegetables provide important vitamins, minerals, and fiber. A 2020 reviewTrusted Source highlights the importance of an overall balanced diet low in processed foods for bone health. However, the review authors suggest further research is necessary.

Research in a 2021 reviewTrusted Source highlights a positive association between bone mass density and fruit and vegetable consumption, which may be due to vitamin intake.

The authors also highlight research suggesting vitamin C intake may improve bone health and protect against osteoporosis. They list the following vegetables as good sources of vitamin C:

Another 2021 reviewTrusted Source suggests that consuming fewer than five servings of fruit or vegetables per day increases the risk of hip fractures.

3. Consume calcium throughout the day

Calcium is the primary nutrient for bone health. As the bones break down and grow each day, it is essential to get enough calcium.

The best wayTrusted Source to absorb calcium is to consume foods containing calcium every day. Getting calcium through the diet is best unless a doctor advises otherwise.

Foods rich in calcium include:

4. Eat foods rich in vitamins D and K

Vitamin K2 is essential to bone health. It reduces calcium loss and helps minerals bind to the bones.

Foods that contain vitamin K2 include:

Vitamin D helps the body absorb calcium. People with vitamin D deficiencies have a higher risk of losing bone mass.

A person can absorb vitamin D through moderate sun exposure. Without sufficient vitamin D, a person has a higher risk of developing bone disease, such as osteoporosis or osteopenia.

5. Maintain a moderate weight

A moderate weight is essential for bone density. People with underweight have a higher risk of developing bone disease. Overweight and obesity put additional stress on the bones.

Doctors recommend people avoid rapid weight loss and cycling between gaining and losing weight. As a person loses weight, they can lose bone density, but gaining back the weight will not restore bone density. This reduction in density can lead to weaker bones.

6. Avoid a low calorie diet

Super low calorie diets can lead to health problems, including bone density loss.

Before restricting calories, discuss calorie needs with a qualified healthcare professional, such as a primary care doctor or registered dietitian, to determine a safe target number of calories to consume.

Any diet needs to balance protein, fats, vitamins, and minerals for optimal health.

7. Eat more protein

Protein plays an essential role in bone health and density.

A 2022 cross-sectional studyTrusted Source examined bone mass and dietary protein intake in 1,570 older adults. Researchers associated higher bone mass density with higher intakes of total and animal protein.

However, they associated lower bone mass density with plant protein intake. Researchers call for further studies, particularly into how a plant-based diet may affect bone health and density.

People can talk with a doctor before significantly altering their protein intake.

8. Eat foods rich in omega-3 fatty acids

ResearchTrusted Source suggests that omega-3 fatty acids play a role in maintaining bone density and overall bone health.

Omega-3 fatty acids are present in a variety of foods, such as:

People can consume these fatty acids through their diet or supplements.

9. Eat foods rich in magnesium and zinc

Like calcium, magnesium and zinc are minerals that support bone health and density.

Magnesium helps activateTrusted Source vitamin D so it can promote calcium absorption. Zinc exists in the bones. It promotesTrusted Source bone growth and helps prevent the bones from breaking down.

Foods rich in magnesium and zinc include:

10. Avoid smoking

Many people associate smoking with lung cancer and breathing issues, but smoking can also increase the riskTrusted Source of conditions such as osteoporosis and bone fractures.

To support healthy bone density, a person can avoid or quit smoking, especially during their teens and young adulthood.

11. Avoid heavy drinking

In moderation, alcohol consumption may notTrusted Source significantly affect a person’s bone health.

However, long-term heavy drinking can lead to poor calcium absorption, a decrease in bone density, and the development of osteoporosis later in life.

Moderate alcohol consumption is consideredTrusted Source two drinks or fewer per day for males and one drink or fewer per day for females.

Is it too late to build bone density?

Although the best time to influence peak bone mass and build bone density is from childhood to early adulthood, people can take steps at every age to improve bone health and reduce bone density loss.

Peak bone mass occurs in younger adults. After this point, people gradually lose bone mass.

However, adults and older adults can take the following steps to minimize bone loss:

  • get at least 150 minutes of physical activity each week
  • consume 1,000 milligrams (mg) of calcium daily, or 1,200 mg for females over 50 years and anyone over 70 years
  • get 1,000 international units (IU) of vitamin D daily, or 800 IU for people over 70 years

Frequently asked questions

Below are some common questions about increasing bone density.

What is the fastest way to improve bone density?

Strength training exercises can increaseTrusted Source bone density in specific parts of the body in the short and medium term. However, people need to continue exercising regularly to maintain bone health in the long term.

Is it possible to rebuild bone density?

Bone mass peaks in young adults, usually between 25 and 30 years old. After 40 years old, people start to lose bone mass. However, they can reduce this loss by exercising regularly and eating a balanced, nutrient-dense diet.

Which foods increase bone density?

Dietary intake of calcium and vitamin D is vitalTrusted Source for bone health. Foods that contain these nutrients include:

  • fish, such as salmon, tuna, and trout
  • leafy green vegetables
  • dairy products, such as milk, cheese, and yogurt

Some manufacturers may fortify certain foods, such as breakfast cereals, with vitamin D.

Summary

Bone density develops throughout a person’s early life, peaking in their late 20s. To support healthy bone density, it is important to consume plenty of calcium, vitamin D, protein, and vegetables.

It is also important to avoid smoking and heavy alcohol use. Taking these steps can help support bone density throughout adulthood.

More body fat linked to lower bone density, especially in men


High levels of body fat are associated with a lower bone mineral density, with the association more pronounced in men compared with women, according to study data published in The Journal of Clinical Endocrinology & Metabolism.

“While higher BMI is generally associated with higher bone density, our study demonstrates that lean and fat mass affect bone density differently and that obesity is not a guarantee against osteoporosis,” Rajesh K. Jain, MD, assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine, told Healio. “Patients with obesity should still undergo recommended bone density screening, especially if they have other risk factors, such as older age, previous fracture, family history or steroid use.”

Rajesh K. Jain, MD
Jain is an assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine

Jain and colleagues analyzed data from 10,814 adults aged 20 to 59 years who participated in the National Health and Nutrition Examination Survey from 2011 to 2018 and underwent a total body DXA scan. T-scores were calculated to determine total body BMD. Lean mass index and fat mass index were calculated to assess the effects of body composition on BMD.

After adjusting for age, sex, race and ethnicity, height, smoking status, lean mass index and fat mass index, every 1 kg/m2 of lean mass index was associated with a 0.19 higher total body BMD T-score (P < .001). Conversely, each 1 kg/m2 increase in fat mass index was associated with a 0.1 decrease in BMD T-score (P < .001).

The association between fat mass index and BMD T-score differed for men and women. Women had a BMD T-score decrease of 0.08 points for every 1 kg/m2 increase in fat mass index, whereas men had a 0.13 lower BMD T-score with every 1 kg/m2 increase in fat mass index (P for interaction < .001). The association between fat mass index and BMD T-score did not differ by age group. For lean mass index, Mexican American adults had a lower BMD T-score increase of 0.16 for each 1 kg/m2 increase compared with a 0.21 BMD T-score increase for each 1 kg/m2 for white adults (P for interaction = .004). There were no other differences observed between race and ethnicity groups.

“Unfortunately, body composition is not a routine clinical measurement, so we rarely know what a patient’s body fat or body lean mass is,” Jain said. “Factors that correlate with high body fat and low lean mass are often associated with osteoporosis or fractures, and their presence should prompt clinicians to consider osteoporosis screening. This includes, for example, the presence of diabetes or poor performance on physical activity measures, such as grip strength.”

Jain said future research should examine the effects that weight loss may have on BMD.

“In general, weight loss has been associated with bone loss and fractures, but this study suggests the type of weight loss — lean vs. fat mass — may be important in determining if or how much bone loss occurs,” Jain said.

For more information:

Rajesh K. Jain, MD, can be reached at rjain2@medicine.bsd.uchicago.edu.

PERSPECTIVE

Mone Zaidi, MD, PhD, MBA, MACP, FRCP)

Mone Zaidi, MD, PhD, MBA, MACP, FRCP

Over the past two decades, we have worked on the idea that pituitary hormones have diverse functions beyond the unitary actions that appear traditionally in endocrine textbooks. We found, for the first time, that thyroid-stimulating hormone and follicle-stimulating hormone have direct actions on bone. The implication of these studies was that low TSH and high follicle-stimulating hormone levels in hyperthyroidism and after menopause likely contribute to the bone loss hitherto attributed solely to high thyroid hormone and low estrogen levels, respectively (Abe E, et al. Cell. 2003;doi:10.1016/s0092-8674(03)00771-2). 

Correlative studies in cohorts across the globe have shown strong associations between serum TSH or follicle-stimulating hormone, markers of bone remodeling, bone mineral density and fracture risk, independently of thyroxine or estrogen. Focusing on the effects of follicle-stimulating hormone, we developed a targeted follicle-stimulating hormone blocking antibody that prevented bone loss in mouse models (Zhu LL, et al. Proc Natl Acad Sci U S A. 2012;doi:10.1073/pnas.1212806109). Intriguingly, the follicle-stimulating hormone blocking antibody also reduced body fat and converted white adipose tissue to thermogenic beige adipose tissue (Liu X, et al, Nature. 2017;doi:10.1038/nmeth.4436) and, in a separate study, prevented cognitive decline and Alzheimer-like neuropathology in mouse models (Xiong, et al, Nature, 2022; in press).

Our humanized monoclonal follicle-stimulating hormone blocking antibody replicates these actions and has shown promise in preclinical studies toward first-in-human clinical trials in the very near future. Our admittedly ambitious premise is to treat osteoporosis, obesity and neurodegeneration with a single drug.

Mone Zaidi, MD, PhD, MBA, MACP, FRCP

Professor of Medicine and Pharmacological Sciences

Director, Center for Translational Medicine and Pharmacology

Director, Mount Sinai Bone Program

Icahn Sinai School of Medicine at Mount Sinai

More body fat linked to lower bone density, especially in men


High levels of body fat are associated with a lower bone mineral density, with the association more pronounced in men compared with women, according to study data published in The Journal of Clinical Endocrinology & Metabolism.

“While higher BMI is generally associated with higher bone density, our study demonstrates that lean and fat mass affect bone density differently and that obesity is not a guarantee against osteoporosis,” Rajesh K. Jain, MD, assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine, told Healio. “Patients with obesity should still undergo recommended bone density screening, especially if they have other risk factors, such as older age, previous fracture, family history or steroid use.”

Rajesh K. Jain, MD
Jain is an assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine

Jain and colleagues analyzed data from 10,814 adults aged 20 to 59 years who participated in the National Health and Nutrition Examination Survey from 2011 to 2018 and underwent a total body DXA scan. T-scores were calculated to determine total body BMD. Lean mass index and fat mass index were calculated to assess the effects of body composition on BMD.

After adjusting for age, sex, race and ethnicity, height, smoking status, lean mass index and fat mass index, every 1 kg/m2 of lean mass index was associated with a 0.19 higher total body BMD T-score (P < .001). Conversely, each 1 kg/m2 increase in fat mass index was associated with a 0.1 decrease in BMD T-score (P < .001).

The association between fat mass index and BMD T-score differed for men and women. Women had a BMD T-score decrease of 0.08 points for every 1 kg/m2 increase in fat mass index, whereas men had a 0.13 lower BMD T-score with every 1 kg/m2 increase in fat mass index (P for interaction < .001). The association between fat mass index and BMD T-score did not differ by age group. For lean mass index, Mexican American adults had a lower BMD T-score increase of 0.16 for each 1 kg/m2 increase compared with a 0.21 BMD T-score increase for each 1 kg/m2 for white adults (P for interaction = .004). There were no other differences observed between race and ethnicity groups.

“Unfortunately, body composition is not a routine clinical measurement, so we rarely know what a patient’s body fat or body lean mass is,” Jain said. “Factors that correlate with high body fat and low lean mass are often associated with osteoporosis or fractures, and their presence should prompt clinicians to consider osteoporosis screening. This includes, for example, the presence of diabetes or poor performance on physical activity measures, such as grip strength.”

Jain said future research should examine the effects that weight loss may have on BMD.

“In general, weight loss has been associated with bone loss and fractures, but this study suggests the type of weight loss — lean vs. fat mass — may be important in determining if or how much bone loss occurs,” Jain said.

For more information:

Rajesh K. Jain, MD, can be reached at rjain2@medicine.bsd.uchicago.edu.

PERSPECTIVE

BACK TO TOP Mone Zaidi, MD, PhD, MBA, MACP, FRCP)

Mone Zaidi, MD, PhD, MBA, MACP, FRCP

Over the past two decades, we have worked on the idea that pituitary hormones have diverse functions beyond the unitary actions that appear traditionally in endocrine textbooks. We found, for the first time, that thyroid-stimulating hormone and follicle-stimulating hormone have direct actions on bone. The implication of these studies was that low TSH and high follicle-stimulating hormone levels in hyperthyroidism and after menopause likely contribute to the bone loss hitherto attributed solely to high thyroid hormone and low estrogen levels, respectively (Abe E, et al. Cell. 2003;doi:10.1016/s0092-8674(03)00771-2). 

Correlative studies in cohorts across the globe have shown strong associations between serum TSH or follicle-stimulating hormone, markers of bone remodeling, bone mineral density and fracture risk, independently of thyroxine or estrogen. Focusing on the effects of follicle-stimulating hormone, we developed a targeted follicle-stimulating hormone blocking antibody that prevented bone loss in mouse models (Zhu LL, et al. Proc Natl Acad Sci U S A. 2012;doi:10.1073/pnas.1212806109). Intriguingly, the follicle-stimulating hormone blocking antibody also reduced body fat and converted white adipose tissue to thermogenic beige adipose tissue (Liu X, et al, Nature. 2017;doi:10.1038/nmeth.4436) and, in a separate study, prevented cognitive decline and Alzheimer-like neuropathology in mouse models (Xiong, et al, Nature, 2022; in press).

Our humanized monoclonal follicle-stimulating hormone blocking antibody replicates these actions and has shown promise in preclinical studies toward first-in-human clinical trials in the very near future. Our admittedly ambitious premise is to treat osteoporosis, obesity and neurodegeneration with a single drug.

Mone Zaidi, MD, PhD, MBA, MACP, FRCP

Professor of Medicine and Pharmacological Sciences

Director, Center for Translational Medicine and Pharmacology

Director, Mount Sinai Bone Program

Icahn Sinai School of Medicine at Mount Sinai

More body fat linked to lower bone density, especially in men


High levels of body fat are associated with a lower bone mineral density, with the association more pronounced in men compared with women, according to study data published in The Journal of Clinical Endocrinology & Metabolism.

“While higher BMI is generally associated with higher bone density, our study demonstrates that lean and fat mass affect bone density differently and that obesity is not a guarantee against osteoporosis,” Rajesh K. Jain, MD, assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine, told Healio. “Patients with obesity should still undergo recommended bone density screening, especially if they have other risk factors, such as older age, previous fracture, family history or steroid use.”

Rajesh K. Jain, MD
Jain is an assistant professor in the section of endocrinology, diabetes and metabolism and director of the endocrinology fellowship program at the University of Chicago Medicine

Jain and colleagues analyzed data from 10,814 adults aged 20 to 59 years who participated in the National Health and Nutrition Examination Survey from 2011 to 2018 and underwent a total body DXA scan. T-scores were calculated to determine total body BMD. Lean mass index and fat mass index were calculated to assess the effects of body composition on BMD.

After adjusting for age, sex, race and ethnicity, height, smoking status, lean mass index and fat mass index, every 1 kg/m2 of lean mass index was associated with a 0.19 higher total body BMD T-score (P < .001). Conversely, each 1 kg/m2 increase in fat mass index was associated with a 0.1 decrease in BMD T-score (P < .001).

The association between fat mass index and BMD T-score differed for men and women. Women had a BMD T-score decrease of 0.08 points for every 1 kg/m2 increase in fat mass index, whereas men had a 0.13 lower BMD T-score with every 1 kg/m2 increase in fat mass index (P for interaction < .001). The association between fat mass index and BMD T-score did not differ by age group. For lean mass index, Mexican American adults had a lower BMD T-score increase of 0.16 for each 1 kg/m2 increase compared with a 0.21 BMD T-score increase for each 1 kg/m2 for white adults (P for interaction = .004). There were no other differences observed between race and ethnicity groups.

“Unfortunately, body composition is not a routine clinical measurement, so we rarely know what a patient’s body fat or body lean mass is,” Jain said. “Factors that correlate with high body fat and low lean mass are often associated with osteoporosis or fractures, and their presence should prompt clinicians to consider osteoporosis screening. This includes, for example, the presence of diabetes or poor performance on physical activity measures, such as grip strength.”

Jain said future research should examine the effects that weight loss may have on BMD.

“In general, weight loss has been associated with bone loss and fractures, but this study suggests the type of weight loss — lean vs. fat mass — may be important in determining if or how much bone loss occurs,” Jain said.

STRONG ASSOCIATION BETWEEN MENOPAUSAL SYMPTOMS, BONE HEALTH


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The first large prospective cohort study to examine the relationship between menopausal symptoms and bone health in postmenopausal women has found that those who experience moderate to severe hot flashes and night sweats during menopause tend to have lower bone mineral density and higher rates of hip fracture than peers with no menopausal symptoms.

The study followed thousands of women for eight years. After adjusting for age, body mass index and demographic factors, it found that women who reported moderate to severe hot flashes at baseline enrollment showed a significant reduction in the bone density in the femoral neck region of their hips over time and were nearly twice as likely to have a hip fracture during the follow-up period.

This study employed data and study participants from the Women’s Health Initiative (WHI) initiated by the U.S. National Institutes of Health (NIH) in 1991 to address major health issues causing morbidity and mortality in postmenopausal women.

The WHI consisted of three clinical trials and an observational study undertaken at 40 clinical centers throughout the US, including the University at Buffalo Clinical Center directed by Wactawski-Wende.

She says the research team examined data from 23,573 clinical trial participants, aged 50 to 79, who were not then using menopausal hormone therapy nor assigned to use it during the trial. They conducted baseline and follow-up bone density examinations in 4,867 of these women.

Wactawski-Wende says, “We knew that during menopause, about 60 percent of women experience vasomotor symptoms (VMS), such as hot flashes and night sweats. They are among the most bothersome symptoms of menopause and can last for many years.

“It also was known that osteoporosis, a condition in which bones become structurally weak and more likely to break, afflicts 30 percent of all postmenopausal women in the United States and Europe, and that at least 40 percent of that group will sustain one or more fragility fractures in their remaining lifetime,” she says.

“What we did not know,” says Wactawski-Wende, “was whether VMS are associated with reductions in bone mineral density or increased fracture incidence.

“Women who experience vasomotor menopausal symptoms will lose bone density at a faster rate and nearly double their risk of hip fracture,” she says, “and the serious public health risk this poses is underscored by previous research that found an initial fracture poses an 86 percent risk for a second new fracture.”

Wactawski-Wende says, “Clearly more research is needed to understand the relationship between menopausal symptoms and bone health. In the meantime, women at risk of fracture may want to engage in behaviors that protect their bones including increasing their physical activity and ensuring they have adequate intakes of calcium and vitamin D.”

Osteoporosis Myth: The Dangers of High Bone Mineral Density.


Bone Scans or Scams? How Dense Bones Can Harm Your Health

The present-day definitions of Osteopenia and Osteoporosis were arbitrarily conceived by the World Health Organization (WHO) in the early 90’s and then projected upon millions of women’s bodies seemingly in order to convince them they had a drug-treatable, though symptomless, disease.

Osteopenia (1992)[i] and Osteoporosis (1994)[ii] were formally identified as skeletal diseases by the WHO as bone mineral densities (BMD) 1 and 2.5 standard deviations, respectively, below the peak bone mass of an average young adult Caucasian female, as measured by an x-ray device known as Dual energy X-ray absorptiometry (DXA, or DEXA). This technical definition, now used widely around the world as the gold standard, is disturbingly inept, and as we shall see, likely conceals an agenda that has nothing to do with the promotion of health.

Deviant Standards: Aging Transformed Into a Disease

A ‘standard deviation’ is simply a quantity calculated to indicate the extent of deviation for a group as a whole, i.e. within any natural population there will be folks with higher and lower biological values, e.g. height, weight, bone mineral density, cholesterol levels. The choice of an average young adult female (approximately 30-year old) at peak bone mass in the human lifecycle as the new standard of normality for all women 30 or older, was, of course, not only completely arbitrary but also highly illogical. After all, why should a 80-year old’s bones be defined as “abnormal” if they are less dense than a 30-year old’s?

Within the WHO’s new BMD definitions the aging process is redefined as a disease, and these definitions targeted women, much in the same way that menopause was once redefined as a “disease” that needed to be treated with synthetic hormone replacement (HRT) therapies; that is, before the whole house of cards collapsed with the realization that by “treating” menopause as a disease the medical establishment was causing far more harm than good, e.g. heart disease, stroke and cancer.

As if to fill the void left by the HRT debacle and the disillusionment of millions of women, the WHO’s new definitions resulted in the diagnosis, and subsequent labeling, of millions of healthy middle-aged and older women with what they were now being made to believe was another “health condition,” serious enough to justify the use of expensive and extremely dangerous bone drugs (and equallydangerous mega-doses of elemental calcium) in the pursuit of increasing bone density by any means necessary.

One thing that cannot be debated, as it is now a matter of history, is that this sudden transformation of healthy women, who suffered no symptoms of “low bone mineral density,” into an at-risk, treatment-appropriate group, served to generate billions of dollars of revenue for DXA device manufacturers, doctor visits, and drug prescriptions around the world.
The Manufacture of a Disease

WHO Are They Kidding?

Osteopenia is, in fact, a medical and diagnostic non-entity.  The term itself describes nothing more than a statistical deviation from an arbitrarily determined numerical value or norm.   According to the osteoporosis epidemiologist Dr. L. Joseph Melton at the Mayo Clinic who participated in setting the original WHO criteria in 1992, “[osteopenia] was just meant to indicate the emergence of a problem,” and noted that “It didn’t have any particular diagnostic or therapeutic significance. It was just meant to show a huge group who looked like they might be at risk.”[iii] Another expert, Michael McClung, director of the Oregon Osteoporosis Center, criticized the newly adopted disease category osteopenia by saying ”We have medicalized a nonproblem.”[iv]

In reality, the WHO definitions violate both commonsense and fundamental facts of biological science (sadly, an increasingly prevalent phenomenon within drug company-funded science).  After all, anyone over 30 years of age should have lower bone density than a 30 year old, as this is consistent with the normal and natural healthy aging process.  And yet, according to the WHO definition of osteopenia, the eons-old programming of our bodies to gradually shed bone density as we age, is to be considered a faulty design and/or pathology in need of medical intervention.

How the WHO, or any other organization which purports to be a science-based “medical authority,” can make an ostensibly educated public believe that the natural thinning of the bones is not normal, or more absurdly: a disease, is astounding. In defense of the public, the cryptic manner in which these definitions and diagnoses have been cloaked in obscure mathematical and clinical language makes it rather difficult for the layperson to discern just how outright insane the logic they are employing really is.

So, let’s look closer at the definitions now, which are brilliantly elucidated by Washington.edu’s  published online course on Bone Densitometry, which can viewed in its entiretyhere.

The Manufacture of a Disease through Categorical Sleight-of-Hand

bone mineral density loss

The image above shows the natural decrease in hip bone density occurring with age, with variations in race and gender depicted.  Observe that loss of bone mineral density with age is a normal process.

Bell Curve Bones

Next, is the classical bell-shaped curve, from which T- and Z-scores are based.  T-sores are based on the young adult standard (30-year old) bone density as being normal for everyone, irregardless of age, whereas the much more logical Z-score compares your bone mineral density to that of your age group, as well as sex and ethnic background.  Now here’s where it gets disturbingly clear how ridiculous the T-score really system is….

WHO definitions osteoporosis

Above is an image showing how within the population of women used to determine “normal” bone mineral density, e.g. 30-year olds, 16% of them already “have” osteopenia” according to the WHO definitions, and 3% already “have” osteoporosis! According to Washington.edu’s online course “One standard deviation is at the 16th percentile, so by definition 16% of young women have osteopenia! As shown below, by the time women reach age 80, very few are considered normal.”

Osteopenia and Osteoporosis Rates with Age

Above you will see what happens when the WHO definitions of “normal bone density” are applied to aging populations. Whereas at age 25, 15% of the population will “have” osteopenia, by age 50 the number grows to 33%. And by age 65, 60% will be told they have either osteopenia (40%) or osteoporosis (20%).

On the other hand, if one uses the Z-score, which compares your bones to that of your age group, something remarkable happens: a huge burden of “disease” disappears!  In a review on the topic published in 2009 in the Journal of Clinical Densitometry, 30-39% of the subjects who had been diagnosed with osteoporosis with two different DXA machine models were reclassified as either normal or “osteopenic” when the Z- score was used instead of the T-score. The table therefore can be turned on the magician-like sleight-of-hand used to convert healthy people into diseased ones, as long as an age-appropriate standard of measurement is applied, which presently it is not.

Bone Mineral Density is NOT Equivalent to Bone Strength

As you can see there are a number of insurmountable problems with the WHO’s definitions, but perhaps the most fatal flaw is the fact that the Dual energy X-ray absorpitometry device (DXA) is only capable of revealing the mineral density of the bone, and this is not the same thing as bonequality/strength.

While there is a correlation between bone mineral density and bone quality/strength – that is to say, they overlap in places — they are not equivalent.  In other words, density, while an excellent indicator of compressive strength (resisting breaking when being crushed by a static weight), is not an accurate indicator of tensile strength (resisting breaking when being pulled or stretched).

Indeed, in some cases having higher bone density indicates that the bone is actually weaker. Glass, for instance, has high density and compressive strength, but it is extremely brittle and lacks the tensile strength required to withstand easily shattering in a fall. Wood, on the other hand, which is closer in nature to human bone than glass or stone is less dense relative to these materials, but also extremely strong relative to them, capable of bending and stretching to withstand the very same forces which the bone is faced with during a fall.  Or, take spider web. It is has infinitely greater strength and virtually no density. Given these facts, having “high” bone density (and thereby not having osteoporosis) may actually increase the risk of fracture in a real-life scenario like a fall.

Essentially, the WHO definitions distract from key issues surrounding bone quality and real world bone fracture risks, such as gait and vision disorders.[v] In other words, if you are able to see and move correctly in our body, you are less likely to fall, which means you are less prone to fracture. Keep in mind also that the quality of human bone depends entirely on dietary and lifestyle patterns and choices, and unlike x-ray-based measurements, bone quality is not decomposable to strictly numerical values, e.g. mineral density scores.  Vitamin K2 and soy isoflavones, for instance, significantly reduce bone fracture rates without increasing bone density.  Scoring high on bone density tests may save a woman from being intimidated into taking dangerous drugs or swallowing massive doses of elemetal calcium, but it may not translate into preventing “osteoporosis,” which to the layperson means the risk of breaking a bone.  But high bone mineral density may result in far worse problems….

High Bone Mineral Density & Breast Cancer

High Bone Mineral Density & Breast Cancer

One of the most important facts about bone mineral density, conspicuously absent from discussion, is that having higher-than-normal bone density in middle-aged and older women actually INCREASES their risk of breast cancer by 200-300%, and this is according to research published in some of the world’s most well-respected and authoritative journals, e.g. Lancet, JAMA, NCI. (see citations below).

While it has been known for at least fifteen years that high bone density profoundly increases the risk of breast cancer  — and particularly malignant breast cancer — the issue has been given little to no attention, likely because it contradicts the propaganda expounded by mainstream woman’s health advocacy organizations. Breast cancer awareness programs focus on x-ray based breast screenings as a form of “early detection,” and the National Osteoporosis Foundation’s entire platform is based on expounding the belief that increasing bone mineral density for osteoporosis prevention translates into improved quality and length of life for women.

The research, however, is not going away, and eventually these organizations will have to acknowledge it, or risk losing credibility.

 

Do You Really Need a Vitamin D Supplement?


A new study says that taking vitamin D supplements for bone-strengthening and protection against osteoporosis is not necessary for healthy middle-aged adults.

But a bone health expert at Cleveland Clinic urges people at risk for vitamin D deficiency to consult their doctors before discontinuing use.

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Studies showed no significant increase in BMD

Recent concerns about the safety risks of taking calcium supplements has led some adults to take vitamin D (without calcium) for bone protection.

The University of Auckland study — a meta-analysis of past studies — found that vitamin D supplements alone had little effect on bone-mineral density (BMD). Investigators combined data from 23 past trials, studying 4082 adults, 92 percent of whom were women. Studies showed no significant increase in BMD in most areas of the body.

In light of this researchers concluded that widespread use of vitamin D for osteoporosis prevention in adults without risk factors for vitamin D deficiency was unwarranted.

Importance of vitamin D shouldn’t be minimized

Chad Deal, MD, was not involved in the study but is Director of the Center of Osteoporosis and Metabolic Bone Disease at Cleveland Clinic.

Though not disagreeing with the study’s conclusions, he worries that the findings may cause some to minimize the positive impact of vitamin D on at-risk people.

“The study is on the effect of vitamin D on BMD, which is modest and not surprising,” says Dr. Deal. “Vitamin D would not be expected to have a large effect unless the patient had severe vitamin D deficiency, in which case the bone density effect could be significant.”

“Patients with vitamin D deficiency should not get the take-home message that vitamin D will not benefit them,” he says.

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Fracture protection and other safeguards

For older, at-risk patients, vitamin D deficiency can have a major impact on fracture, says Dr. Deal. Deficiency can cause osteomalacia, softening of the bone due to impaired mineralization, which makes fractures more likely.

Bone mineral density is not a perfect surrogate for fracture, especially in older patients,” Dr. Deal says.

Vitamin D can also have “huge benefits” on muscle function, cognition and falling, he adds.

Healthy middle-aged adults should talk to their doctor about both their vitamin D and calcium levels to see if they need to be taking vitamin D supplements, either alone or with calcium.

Denosumab increased adherence, BMD in postmenopausal patients.


Patients previously treated with a bisphosphonate who still have a high risk for fracture may benefit from the addition of denosumab, according to data presented at ASBMR 2013.

 “We have in fact shown a more robust increase in [bone mineral density] at the end of the 1 year, based on total hip, femoral neck and lumbar spine. We also showed a larger reduction in bone turnover markers,” Jacques P. Brown, MD, of the CHU de Quebec Research Center and Laval University in Canada, told Endocrine Today.

The multicenter, randomized, open-label, parallel-group studies included postmenopausal women aged at least 55 years who were randomly assigned to denosumab 60 mg (Prolia, Xgeva; Amgen) subcutaneously every 6 months (n=852) or a bisphosphonate (ibandronate [Boniva, Roche] orrisedronate [Actonel, Warner Chilcott]) 150 mg by mouth each month for 12 months (n=851; mean age, 67 years). The mean T-scores of the patients were: –1.7 at the total hip, –2 at the femoral neck, and –2.4 at the lumbar spine.

 

The researchers conducted a combined post-hoc analysis on patients with a greater risk for fracture administered denosumab or bisphosphonate.

Patients at higher risk for fracture who were administereddenosumab appeared to have a significantly increased BMD compared with those assigned to a bisphosphonate at the total hip (2.2% vs. 0.8%), femoral neck (1.8% vs. 0.3%), and lumbar spine (3.8% vs. 1.4%), according to 12-month data.

“The important finding was that patients who appeared to be noncompliant with bisphosphonates improved their level of adherence when switched to denosumab,” Brown told Endocrine Today.

These findings were consistent with the overall study population (treatment-by-risk subgroup interaction P>.05), according to data. Further, adverse events and serious adverse events were similar between those assigned denosumab compared with those assigned bisphosphonates.

“There is a clear advantage to switching postmenopausal patients to a more convenient approach like a subcutaneous injection every 6 months,” Brown said.

Source: Endocrine Today.

 

Vitamin D pills’ effect on healthy bones queried.


Supplements

Healthy adults do not need to take vitamin D supplements, suggests a study in The Lancet which found they had no beneficial effect on bone density, a sign of osteoporosis.

But experts say many other factors could be at play and people should not stop taking supplements.

University of Auckland researchers analysed 23 studies involving more than 4,000 healthy people.

The UK government recommends children and over-65s take a daily supplement.

The New Zealand research team conducted a meta-analysis of all randomised trials examining the effects of vitamin D supplementation on bone mineral density in healthy adults up to July 2012.

The supplements were taken for an average of two years by the study participants.

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I’m not surprised they didn’t find any evidence of the effects of vitamin D on bone density because there are so many other factors involved…”

Dr Laura Tripkovic University of Surrey

Bone mineral density is a measure of bone strength and measures the amount of bone mineral present at different sites in the body. It is often seen as an indicator for the risk of osteoporosis, which can lead to an increased risk of fracture.

The trials took place in a number of different countries including the UK, the US, Australia, Holland, Finland and Norway.

Although the results did not identify any benefits for people who took vitamin D, they did find a small but statistically significant increase in bone density at the neck of the femur near the hip joint.

According to the authors, this effect is unlikely to be clinically significant.

Free up resources

Prof Ian Reid, lead study author, from the University of Auckland, said the findings showed that healthy adults did not need to take vitamin D supplements.

“Our data suggest that the targeting of low-dose vitamin D supplements only to individuals who are likely to be deficient could free up substantial resources that could be better used elsewhere in healthcare.”

Writing about the study in The Lancet, Clifford J Rosen from the Maine Medical Research Institute agrees that science’s understanding of vitamin D supports the findings for healthy adults, but not for everyone.

“Supplementation to prevent osteoporosis in healthy adults is not warranted. However, maintenance of vitamin D stores in the elderly combined with sufficient dietary calcium intake remains an effective approach for prevention of hip fractures.”

The Department of Health currently recommends that a daily supplement of vitamin D of 10 micrograms (0.01mg) should be taken by pregnant and breastfeeding women and people over 65, while babies aged six months to five years should take vitamin drops containing 7 to 8.5 micrograms (0.007-0.0085mg) per day.

Additional factors

Dr Laura Tripkovic, research fellow in the department of nutritional sciences at the University of Surrey, said the study was important but very specific.

“I’m not surprised they didn’t find any evidence of the effects of vitamin D on bone density because there are so many other factors involved in osteoporosis, like genes, diet and environment.

“To pin it all on vitamin D… it’s difficult to do that.”

Dr Tripkovic said it was no good taking vitamin D supplements if people didn’t also maintain a healthy, balanced diet containing calcium and take plenty of exercise.

She said most healthy people should be able to absorb enough vitamin D naturally, through sunshine and diet.

“But if people are worried about their vitamin D levels then a multi-vitamin tablet would do. If you have bone pain and muscle aches then you should go and see your GP and discuss it.”

We get most of our vitamin D from sunlight on our skin, but it is also found in certain foods like oily fish, eggs and breakfast cereals.

However, taking too much vitamin D in the form of supplements can be harmful because calcium can build up and damage the kidneys.

Experts advise taking no more than 25 micrograms (0.025mg) a day.

The UK guidance is currently being reviewed.