You are here

Osteoporosis Treatment Abaloparatide Succeeds in Postmenopausal Women

Synthetic peptide reduces new vertebral and nonvertebral fractures

Positive results have been announced from a phase 3 study of self-administered subcutaneous (SC) abaloparatide (Radius Health, Inc.) for the treatment of postmenopausal women with osteoporosis. The study showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (P < 0.001) and nonvertebral fractures (P = 0.049) compared with placebo.

The results were published in the Journal of the American Medical Association.

The Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) was an 18-month, randomized, double-blind, placebo-controlled, international study in 2,463 postmenopausal women with osteoporosis. The study was designed to evaluate the efficacy and safety of an 80-mg SC injection of abaloparatide in reducing the risk of vertebral and nonvertebral fractures.

Abaloparatide is a synthetic peptide that engages the parathyroid hormone 1 (PTH1) receptor. It was designed for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for fractures.

Self-administered SC abaloparatide has completed phase 3 development for potential daily use. Radius submitted a new drug application (NDA) for SC abaloparatide to the FDA at the end of the first quarter of 2016. The NDA was accepted for filing with a Prescription Drug User Fee Act (PDUFA) goal date of March 30, 2017. Radius is also developing a transdermal formulation of abaloparatide based on patented Microstructured Transdermal System (3M Company) technology for potential use as a treatment for osteoporosis.

An estimated two million osteoporotic fractures occur annually in the U.S., and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation has estimated that 10 million people in the United States––eight million women and two million men––have osteoporosis, and that approximately 44 million more people have low bone mass that places them at increased risk for osteoporosis.

Source: Radius; August 16, 2016.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs