osteoporosis treatment

Inadequate osteoporosis treatment persists after major fractures

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Only 1 in 10 men and fewer than 2 in 10 women who did not receive osteoporosis therapy at the time of a fracture were prescribed adequate treatment during follow-up, increasing secondary fracture risks for those left untreated, according to an analysis of data from Austria published in Bone.

Oliver Malle

“The incidence of osteoporotic fractures in Austria is among the highest worldwide,” Oliver Malle, MD, of the division of endocrinology and diabetology at Medical University of Graz, Austria, and colleagues wrote in the study background. “However, so far, no sufficient data has been available on the incidence of osteoporosis treatment in patients suffering an osteoporotic fracture. Furthermore, due to substantial differences in health care systems, results from other countries in which treatment rate after major osteoporotic fractures has been investigated cannot be directly extrapolated to Austria.”

Malle and colleagues analyzed data from 915 adults recruited from eight trauma centers throughout Austria, as part of the International Costs and Utilities Related to Osteoporotic Fractures Study, a prospective observational study assessing data from patients who experienced a major osteoporotic fracture (78.3% women; mean age, 75 years). Researchers stratified participants into two groups: those with osteoporosis treatment at time of fracture (bisphosphonates, estrogens, parathyroid hormone, selective estrogen receptor modulators, or SERMS, and calcitonin) and those without treatment. A first interview was performed during inpatient care or no less than 2 weeks after fracture. Follow-up interviews were performed by phone call at 4, 12 and 18 months after fracture. All fractures were confirmed via X-ray.

Within the cohort, 624 patients (68.2%) were available at 4 months, 552 patients (60.3%) were available at 12 months and 495 patients (54.1%) were available at 18 months after the index fracture.

Fracture arm 3 2019

Only 1 in 10 men and fewer than 2 in 10 women who did not receive osteoporosis therapy at the time of a fracture were prescribed adequate treatment during follow-up, increasing secondary fracture risks for those left untreated.

Source: Adobe Stock

At the time of fracture, 184 patients (20.1%) received pharmacologic treatment and 731 (79.9%) did not. Compared with those who did not receive osteoporosis treatment, those who did were younger, more likely to have a prevalent fracture, and more likely to show two risk factors for osteoporosis (current corticosteroid therapy and parental history of proximal femur fracture) and intake of analgesic medication.

The researchers also observed large treatment disparities by sex. Among women with no osteoporosis treatment at the time of the index fracture, follow-up analysis revealed an osteoporosis treatment rate of 17.6%, 16% and 15.3% after 4, 12 and 18 months, respectively. Among men, the treatment rate was 8.1%, 12.1% and 10.4% at 4, 12 and 18 months, respectively.

Among participants initially treated for osteoporosis, the treatment rate was 65.4%, 54.2% and 60.4% for women, and 66.9%, 55.1% and 55.2% for men after 4, 12 and 18 months, respectively. At the time of fracture, the most frequently prescribed drugs were bisphosphonates (88%) and SERMs (4.3%). Additionally, osteoporosis treatment was lower among men vs. women 4 months after fracture (8% vs. 17.6%; P = .01).

“In those who did not receive osteoporosis treatment at the time of fracture, only 1 in 10 men and less than 2 in 10 women were prescribed an adequate osteoporosis treatment,” the researchers wrote. “In those who had received osteoporosis treatment at the time of fracture, roughly every second patient was deprived of his/her treatment.”

The researchers noted that the relatively short observation period of 18 months could further overestimate the adherence to osteoporosis treatment, so the treatment rate may decrease even further.

In a consensus statement spearheaded by the American Society for Bone and Mineral Research (ASBMR) and the Center for Medical Technology Policy and reported by Endocrine Today, a coalition of stakeholders wrote this month that older adults who sustain a hip or vertebral fracture should be appropriately evaluated and treated for osteoporosis to reduce the risk for secondary fracture, with clinicians utilizing fracture liaison services and offering pharmacotherapy. The coalition developed 13 recommendations, centered on an “overarching principle” that older adults with a hip or vertebral fracture optimally should be managed in the context of a multidisciplinary clinical system that includes case management, such as a fracture liaison service, to ensure patients are appropriately evaluated and treated.

Single-dose zoledronic acid improves BMD in frail older women

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A single infusion of zoledronic acid in frail older women with cognitive impairment and mobility issues improved both bone density and bone turnover for 2 years, according to research in JAMA Internal Medicine.

The 2-year, randomized, placebo-controlled, double blind study suggests that even the most vulnerable patients can respond well to a bisphosphonate for osteoporosis treatment, according to researchers.

“Trials of younger and healthier elderly suggest that the risk of a devastating hip fracture can be cut in half with such therapy, so it’s important to know if that’s also true, for instance, for seniors in nursing homes,” Susan Greenspan, MD, of the department of medicine at University of Pittsburgh, toldEndocrine Today.

Susan Greenspan

Greenspan and colleagues analyzed data from 181 women aged 65 years or older with osteoporosis, including patients with cognitive impairments and immobility who lived in nursing homes or assisted living facilities, as part of the ZEST study. Participants were enrolled and treated from December 2007 to March 2012. All patients received either 5 mg IV zoledronic acid or placebo, as well as a daily divided dose of vitamin D (800 IU/day) and 1,200 mg/day of elemental calcium. Researchers measured hip and spine bone mineral density, as well as adverse events, such as falls, at 12 and 24 months.

Mean BMD at the hip increased by 2.8% for the treatment group compared with a –0.5% loss for the placebo group at 12 months (P < .001); a 2.6% increase compared with a –1.5% loss was observed for the treatment and placebo groups, respectively, at 24 months (P < .001). The treatment group also had a greater increase in mean spine BMD at 12 months (3% vs. 1.1%; P = .01) and at 24 months (4.5% vs. 0.7%; P < .001). Results were maintained after adjustment for a baseline imbalance in frailty, diabetes and anticonvulsant use, and there were no significant differences between groups in the number of deaths, fractures or cardiac events, according to researchers.

The study marks the first randomized trial of a potent antiresorptive therapy with a group of frail older women. With research now suggesting the drug can be administered to this particular group safely and is well tolerated, a larger trial is needed to determine whether fracture reduction can also be achieved, according to researchers.

“This study has answered those questions and, thereby, sets the stage for the bigger trial, which we hope will be funded by NIH,” Greenspan said. – by Regina Schaffer

Osteonecrosis of the Jaw Is Rare With Denosumab for Bone Loss

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Osteonecrosis of the jaw (ONJ) is rare in patients taking the antiresorptive drug denosumab (Prolia), even when invasive dental procedures are performed, according to up to 8 years of data from the FREEDOM and FREEDOM extension studies.

“The clinical significance of these findings is that doctors and patients can be reassured that, even with long-term denosumab therapy, the risk of developing ONJ is very low,” said study investigator Michael McClung, MD, from the Oregon Osteoporosis Center in Portland.

“For patients with osteoporosis who deserve treatment to reduce fracture risk, concern about ONJ should not prevent them from receiving appropriate, effective osteoporosis treatment.”

The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study (N Engl J Med 2009; 361(8): 756-765) randomized women ages 60 to 90 years with osteoporosis to receive either 60 mg denosumab (n=3902) or placebo (n=3906) every 6 months for 3 years, explained McClung, who presented the findings at the annual meeting of the American College of Rheumatology.

At the end of the study, subjects in the placebo arm were given the opportunity to continue or cross over to the active drug for another 7 years in the ongoing FREEDOM extension study (J Endocrinol Metab 2013; 98(11): 4483-4489).

Three years into the extension study, patients were asked every 6 months about invasive oral procedures or events (OPE), which have been suggested as risk factors for ONJ.

Of the 3,536 women who agreed to complete the questionnaire, 58% (n=2036) reported no OPEs, and 42% (n=1500) reported OPEs such as root scaling, tooth extraction, dental implants, spontaneous tooth loss, or other invasive procedures involving the jaw.

There were a total of eight adjudicated ONJ cases, seven of which (0.47%) were reported in women with a history of OPEs and one (0.05%) in a woman with no OPE history. “She had dentures and upon removing them exposed bone was seen,” said McClung. “She was asymptomatic, but a diagnosis of adjudicated ONJ was made.”

Looking at duration of denosumab exposure, the study found that the percentage of patients with OPEs was balanced between those who had been on treatment from the start of the FREEDOM study and those who had crossed over to active treatment for the FREEDOM extension trial (41.8% versus 43.1%).

“This is likely similar to the frequency of OPEs among women of the same age without osteoporosis or without denosumab therapy — since there is no evidence that denosumab therapy increases the frequency of OPEs,” he said

Of the eight ONJ cases, five were in the long-term treatment arm, occurring after 11 doses (n=2), 12 doses (n=2), and 13 doses (n=1) of denosumab, while the three cases in the crossover arm occurred after three, four, and eight doses respectively.

During the extension study, the overall exposure-adjusted incidence of ONJ was 4.2 per 10,000 patient-years.

While OPEs were common on the cohort and appear to be a risk factor for ONJ, “the risk of ONJ in such patients is very low, even among those who underwent OPEs,” with the risk remaining much in patients with cancer-related bone diseases receiving high doses of the drug.

“No one knows for sure why the risk of ONJ is so very much higher with zoledronic and denosumab used to treat patients with cancer,” he commented. “Certainly the doses used in those patients are higher — but the patients are also very different: they have cancer, are receiving chemotherapy, and are immunocompromised. It is certainly not as simple as a dose effect.”