Abaloparatide: A Comprehensive Clinical and Pharmacological Monograph

I. Overview and Key Findings

Abaloparatide is a potent, second-generation osteoanabolic agent approved for the treatment of osteoporosis in patients at high risk of fracture. As a synthetic analog of human parathyroid hormone-related protein (PTHrP), it represents a significant therapeutic option within the class of parathyroid hormone and analogues.[1] Its primary indication is for postmenopausal women with osteoporosis who have a history of osteoporotic fracture, multiple risk factors for fracture, or who have failed or are intolerant to other available osteoporosis therapies. Subsequently, its approval was expanded to include the treatment of men with osteoporosis at a similarly high risk for fracture.[1]

The clinical efficacy of abaloparatide is firmly established through pivotal Phase 3 clinical trials. The Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) demonstrated a remarkable 86% relative risk reduction in new vertebral fractures and a 43% reduction in nonvertebral fractures in postmenopausal women over 18 months compared to placebo.[5] The Abaloparatide Treatment of Men (ATOM) trial confirmed its efficacy in the male population, showing robust increases in bone mineral density (BMD) at the lumbar spine and hip.[4] The benefits of a finite course of abaloparatide therapy are sustained and enhanced when followed by an antiresorptive agent, as demonstrated in the ACTIVExtend study, validating a sequential "build and maintain" therapeutic strategy.[7]