Abaloparatide dose-dependently increases bone mineral density in postmenopausal women with osteoporosis: a phase 2 study.

Abstract

This study aimed to determine the efficacy of abaloparatide in increasing bone mineral density (BMD) and its safety in postmenopausal Japanese women with osteoporosis. Randomized, double-blind, placebo-controlled, dose-finding study of abaloparatide in postmenopausal Japanese women at high fracture risk. The primary endpoint was the change in lumbar spine (LS) BMD from baseline at the last visit after daily subcutaneous injections of placebo or 40 or 80µg abaloparatide. Other endpoints included time-course changes in LS BMD at 12, 24, and 48weeks, in total hip (TH) and femoral neck (FN) BMDs, and in bone turnover markers. Increases in LS BMD with 40 and 80µg abaloparatide were significantly higher than that with placebo (6.6% and 11.5%, respectively), with significant between-group differences for the abaloparatide groups (4.9%). TH BMD increased by 0.4%, 1.6%, and 2.9% and FN BMD increased by 0.6%, 1.5%, and 2.4% in the placebo and 40and 80µg abaloparatide groups, respectively. Serum PINP rapidly increased by 67.3% and 140.7% and serum CTX slowly increased by 16.4% and 34.5% in the 40and 80µg abaloparatide groups, respectively. Although more adverse events were observed in the abaloparatide groups, they were mild to moderate and not dose dependent. In postmenopausal Japanese women with osteoporosis at high fracture risk, abaloparatide for 48weeks dose-dependently increased LS, TH, and FN BMDs, supporting further investigation with 80μg abaloparatide for the treatment of osteoporosis in this population. JapicCTI-132381.