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Abaloparatide lowers fracture risk in postmenopausal osteoporosis

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SAN DIEGO — A synthetic form of human parathyroid hormone-related protein, abaloparatide, significantly reduced the rate of new fractures in women with postmenopausal osteoporosis, according to study findings presented here.

In the phase 3 ACTIVE trial, new spinal fractures were reduced by 86%, and statistically significant reductions were found at other parts of the body.  

“The investigational drug abaloparatide-SC, if approved, may offer patients the potential to reduce their risk of fracture and increase bone density at all sites, even the most difficult to treat, such as the hip and wrist,” Paul Miller, MD, lead investigator and medical director of the Colorado Center for Bone Research in Lakewood, Colorado, said in a press release.

Paul Miller

In the double-blind, placebo-controlled trial, researchers randomly assigned women with postmenopausal osteoporosis (mean age 68.8 years, BMI 25.1 kg/m²) to 80-µg daily injections of the osteoanabolic parathyroid hormone-related protein (PTHrP) analogue abaloparatide (n = 690), sham injections (n = 711) or open-label 20-µg teriparatide injections daily (n = 717). All participants took calcium and vitamin D supplements.

After 18 months, the new incident vertebral fracture rate was 86% lower in the abaloparatide group compared with the placebo group (fracture rates 0.58% and 4.22%, respectively; P < 0.0001) and 80% lower in the teriparatide group (0.84%; P < 0.0001 vs. placebo).

“We believe this reduction seen in the abaloparatide-SC treated group could be the largest reduction ever demonstrated in the vertebral fracture rate for any potential therapeutic drug being researched for the treatment of postmenopausal osteoporosis,” Miller said.

Nonvertebral fractures, at the hip, wrist and femoral neck, also were reduced in the abaloparatide group compared with placebo (Kaplan-Meier estimated fracture rate = 2.7%, HR = 0.57, P = 0.0489); teriparatide was not significantly different from placebo.

Bone mineral density was increased in the abaloparatide and teriparatide groups vs. placebo at the spine, femoral neck and hip at 6, 12 and 18 months (P < 0.0001 for all comparisons) and in the abaloparatide compared with the teriparatide group at the hip at months 6, 12 (both P < 0.0001) and 18 (P = 0.0003), in the femoral neck at 6, 12 (P < 0.0001) and 18 (P = 0.0016) and in the  spine at 6 (P < 0.0001) and 12 (P = 0.0087). ­– by Jill Rollet

Reference:

Miller P, et al. LB-OR01-3. Presented at: The Endocrine Society Annual Meeting; March 5-8, 2015; San Diego.

Disclosure: This study is funded by Radius Health.