Efficacy and safety of transdermal abaloparatide in postmenopausal women with osteoporosis: a randomized study

The objective of this study was to evaluate efficacy and safety of abaloparatide microstructured transdermal system (abaloparatide-sMTS) as an alternative to the SC formulation.This phase 3, noninferiority study (NCT04064411) randomly assigned postmenopausal women with osteoporosis (N  = 511) 1:1 to open-label abaloparatide administered daily via abaloparatide-sMTS or SC injection for 12 months. Primary comparison between treatment groups was percentage change in lumbar spine bone mineral density (BMD) at 12 months, with a noninferiority margin of 2.0%. Secondary endpoint s included percentage change in total hip and femoral neck BMD, bone turnover markers, dermatologic safety, and new clinical fracture incidence.At 12  months, percentage increase from baseline in lumbar spine BMD was 7.14% (standard error: 0.46%) for abaloparatide-sMTS and 10.86% (0.48%) for abaloparatide-SC (treatment difference: −3.72% [95% confidence interval: −5.01%, −2.43%]). Percentage change in total hip BMD was 1.97% for abalopara tide-sMTS and 3.70% for abaloparatide-SC. Median changes from baseline at 12 months in serum procollagen type I N-terminal propeptide (s-PINP) were 52.6% for abaloparatide-sMTS and 74.5% for abaloparatide-SC. Administration site reactions were the most frequently reported adverse events (abalopara tide-sMTS, 94.4%; abaloparatide-SC, 70.5%). Incidence of serious adverse events was similar between groups. Mild or moderate skin reactions occurred with abalopa...
Source: Journal of Bone and Mineral Research - Category: Orthopaedics Authors: Tags: Research Article Source Type: research