Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial

What Was Tested

Researchers studied Abaloparatide and Teriparatide in this randomized controlled trial publication.

Abaloparatide is a selective activator of the parathyroid hormone type 1 receptor.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, women only.

Postmenopausal women with bone mineral density (BMD) T score ≤-2.5 and >-5.0 at the lumbar spine or femoral neck and radiological evidence ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or history of low-trauma nonvertebral fracture within the past 5 years were eligible.

Postmenopausal women (>65 y) with fracture criteria and a T score ≤-2.0 and >-5.0 or without fracture criteria and a T score ≤-3.0 and >-5.0 could enroll.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

Because people in this Abaloparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Abaloparatide, so expectations could not easily colour the readings.

Everyone knew when Abaloparatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The comparison arm used a placebo, so changes seen with Abaloparatide could be set against what happens without it.

The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) was a phase 3, double-blind, RCT (March 2011-October 2014) at 28 sites in 10 countries.

What Was Measured

PubMed files the paper under topics including Bone Density, Bone Density Conservation Agents, Femur Neck, Hypercalcemia, Lumbar Vertebrae, Osteoporosis, Postmenopausal and Osteoporotic Fractures.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Abaloparatide and Teriparatide.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (JAMA), a journal based in United States.

More context: the Abaloparatide compound page and the Teriparatide compound page, all human trials.