Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

What Was Tested

In this phase 3 trial, researchers set out to test Abaloparatide and Teriparatide.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and teriparatide (active comparator).

Placebo identical in appearance to BA058 study drug.

Blinded until after randomization, then open-label.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 2463 actual participants took part.

It was open to women only aged from 50 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Normal physical exam, vital signs, electrocardiogram (ECG) and medical history. Laboratory tests within the normal range including serum calcium, PTH(1-84), serum phosphorus and alkaline phosphatase.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: history of more than 4 mild or moderate spine fractures or any severe fracture; abnormality of the spine or hip that would prohibit assessment of bone mineral density (bmd); prior treatment with parathyroid hormone (pth) or parathyroid hormone-related peptid (pthrp).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Abaloparatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Abaloparatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-04 with completion listed for 2014-10.

It ran at 28 sites in Poland (6), United States (5), Brazil (5), Czechia (3), Denmark (3) and Estonia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With New Vertebral Fractures at 18 Months (time frame: 18 months).

It also tracked 5 secondary outcomes, for example Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months, Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18, Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18 and Number of Participants With Non-vertebral Fractures at 18 Months.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Abaloparatide and Teriparatide in 2463 people.

With 2463 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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