Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Abaloparatide and Prevention of New Vertebral Fractures
JAMA; 2016 Aug 16; Miller, Hattersley, et al
The use of abaloparatide reduced the risk of new vertebral and nonvertebral fractures among postmenopausal women with osteoporosis over an 18-month period when compared to placebo, a recent study found. The phase III, double-blind randomized clinical trial included 2,463 postmenopausal women (mean age 69 years) who underwent either injections of placebo (n=821), abaloparatide 80 µg (n=824), or open-label teriparatide 20 µg (n=818) for 18 months. Researchers found:
• 1,901 women completed the study.
• New morphometric vertebral fractures occurred in 0.58% of the abaloparatide group, 4.22% of the placebo group, and 0.84% of the teriparatide group.
• The Kaplan-Meier estimated event rate for nonvertebral fracture was 2.7% for abaloparatide, 4.7% for placebo, and 3.3% for teriparatide.
• Bone mineral density increases were greater with abaloparatide than with placebo.
• Incidence of hypercalcemia was lower with abaloparatide (3,4%) than with teriparatide (6.4%).
Miller PD, Hattersley G, Riis B, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: A randomized clinical trial. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136.
Approximately 40% of women will develop an osteoporotic fracture at some point in their lives.1 The National Osteoporosis Foundation Clinicians Guide2 recommends bone mineral density (BMD) testing should be performed:
• In women age 65 and older and men age 70 and older.
• In postmenopausal women and men above age 50–69, based on risk factor profile.
• In postmenopausal women and men age 50 and older who have had an adult age fracture.
In addition, vertebral imaging should be performed in selected patients.
Parmacologic treatment should be considered in individuals with:
• Hip or vertebral fractures.
• T-scores ≤−2.5 at the femoral neck, total hip, or lumbar spine by DEXA.
• Postmenopausal women and men aged 50 and older with T-score between −1.0 and −2.5, (ie, osteopenia) at the femoral neck, total hip, or lumbar spine, and a 10-year hip fracture probability ≥3 %, or a 10-year major osteoporosis-related fracture probability ≥20 % based on the FRAX score model.
Abaloparatide, which selectively binds to the parathyroid hormone type 1 receptor, appears to be effective in improving bone mineral density and decreasing fracture risk over a relatively short period of time. —Neil Skolnik, MD
1. Cawthon PM. Gender differences in osteoporosis and fractures. Clin Orthop Relat Res. 2011;469(7):1900-1905.
2. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporosis Int. 2014;25(10):2359-81. doi:10.1007/s00198-014-2794-2.