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ACTIVE trial: Abaloparatide reduced risk of fractures in women with osteoporosis
New morphometric vertebral fractures occurred more frequently in the placebo group.
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Subcutaneous injections of abaloparatide reduced the risk of new vertebral and non-vertebral fractures among postmenopausal women with osteoporosis during an 18-month period, according to results from the phase 3 Abaloparatide Comparator Trial in Vertebral Endpoints.
“You saw a more rapid increase in cortical bone density and a high increase in cortical bone density at the hip than you did with teriparatide and certainly with placebo,” Paul D. Miller, MD, medical director of the Colorado Center for Bone Research, told Orthopedics Today. “The increase was sooner and greater, and that may be one of the reasons why we saw a significant reduction in non-vertebral fractures in these studies.”
Abaloparatide vs placebo
Researchers randomly assigned 2,463 postmenopausal women with osteoporosis to receive either 80 µg of abaloparatide, 20 µg of open-label teriparatide or placebo for 18 months. The primary endpoint of the study was defined as the percentage of participants with new vertebral fractures in the abaloparatide compared to the placebo group, which was set to identify a 4% difference between groups. Researchers also looked at change in bone mineral density (BMD) in the total hip, femoral neck and lumbar spine and time to first incidence of non-vertebral fracture as secondary endpoints.
Overall, 77.2% of patients completed all study visits, with 73.5% of patients in the abaloparatide group, 80.4% of patients in the teriparatide group and 77.6% of patients in the placebo group. Researchers found more patients in the placebo group had new morphometric vertebral fractures compared to the abaloparatide and teriparatide groups.
Participants in the abaloparatide group had greater increases in bone mineral density for the femoral neck and total hip at 6 months compared to the teriparatide group. From baseline to 18 months, the abaloparatide group had significant changes in BMD at the total hip, femoral neck and lumbar spine compared with the placebo group.
Kaplan-Meier showed a 2.7% event rate for nonvertebral fractures in the abaloparatide group, 4.7% in the placebo group and 3.3% in the teriparatide group. Researchers predefined hypercalcemia as albumin-corrected serum calcium level of at least 10.7 mg/dL. The overall incidence of this condition was significantly lower in the abaloparatide group (3.4%) compared to the teriparatide group (6.4%).
Extension study
Miller noted an extension of this study was performed that looked at the effects of using an antiresorptive agent after an anabolic agent, which will be presented at the American Society for Bone and Mineral Research Annual Meeting.
“I believe the company, although I do not know this for sure, will be doing phase 3b studies or phase 4 for men [and] for patients on steroids because steroids inhibit bone formation and of course, abaloparatide assimilates bone formation. I think there will be fracture healing trials,” Miller said. –by Casey Tingle
- Reference:
- Miller PD, et al. JAMA. 2016;doi:10.1001/jama.2016.11136.
- For more information:
- Paul D. Miller, MD, can be reached at the Colorado Center for Bone Research, PC, 3190 S. Wadsworth Blvd., Suite 250, Lakewood, Co 80227; email: millerccbr@aol.com.
Disclosure: Miller reports he is a member of scientific advisory boards for AgNovos, Amgen, Eli Lilly, Merck, Radius Health, Roche and Ultragenyx; receives research grants from Alexion, Amgen, Boehringer-Ingelheim, Daiichi-Sankyo, Eli Lilly, Immunodiagnostics, Merck, Merck Serono, National Bone Health Alliance, Novartis, Radius Health, Regeneration, Roche Diagnostics and Ultragenyx and serves on data and safety committees for Allergan and the Grünenthal Group.