1. Abaloparatide significantly reduced the risk of new vertebral and non-vertebral fractures compared with placebo.
2. Treatment with abaloparatide also resulted in higher bone mineral density (BMD) gains compared with placebo and teriparatide.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Vertebral fractures disproportionately affect post-menopausal women, and lead to a lower quality of life and significant economic costs. Current treatments for osteoporosis include lifestyle modifications, adequate calcium and vitamin D intake, bisphosphonates, and hormonal therapy. The purpose of this study was to evaluate the efficacy of abaloparatide, a selective agonist of the parathyroid hormone type 1 receptor, on reducing vertebral and non-vertebral fractures in post-menopausal women with osteoporosis.
Patients taking abaloparatide had a significantly lower risk of developing new vertebral and non-vertebral fractures than those given placebo. The treatment group also had significant gains in bone mineral density (BMD) at the femoral neck, total hip, and lumbar spine compared to placebo. The risk of hypercalcemia was lower in the abaloparatide group compared with those taking open-label teriparatide, possibly indicating that abaloparatide results in less bone resorption.
Overall, this study suggests that use of abaloparatide reduces the risk of vertebral and non-vertebral fractures in post-menopausal osteoporotic women. However, the majority of study participants had a prior fracture, and it is not easily understood whether abaloparatide could have a similar benefit profile in patients with a lower risk of fracture.
Relevant Reading: Clinician’s guide to prevention and treatment of osteoporosis
In-Depth [randomized controlled trial]: This study was conducted as a subgroup analysis within the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) randomized clinical trial. In this phase 3, double-blind RCT, 2463 women (mean age 69 years) were randomized to receive 18 months of daily subcutaneous injections of abaloparatide 80 µg (n = 824), placebo (n = 821), or open-label teriparatide 20 µg (n = 818). A significant reduction in the primary outcome of new vertebral fractures was observed with abaloparatide compared to placebo (risk difference -3.64; 95%CI -5.42 to -2.10; p < 0.001). Bone mineral density gains were significant with abaloparatide vs. placebo at 6, 12, and 18 months (all p < 0.001), and risk of hypercalcemia also lower with abaloparatide vs. teriparatide (RD -2.96; 95%CI -5.12 to -0.87). Mild to moderate adverse events leading to study discontinuation occurred more frequently in the abaloparatide group, while serious events occurred at similar levels in the abaloparatide and teriparatide groups.
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