Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis

What Was Tested

This registered phase 2 trial tested Abaloparatide.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 250 actual participants took part.

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

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

Examples of who could join: Postmenopausal woman, less than 85 years old. BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years). Normal physical exam, vital signs, electrocardiogram (ECG), and medical history. Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: BMD T-score ≤-5.0 at the lumbar spine or hip; history of bone disorders (for example, paget's disease) other than postmenopausal osteoporosis; history of any cancer.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Abaloparatide.

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

It started in 2012-09-25 with completion listed for 2013-08-02.

It ran at 9 sites in United States (3), Denmark (3), Poland (2) and Estonia (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months (time frame: Baseline, 6 Months).

It also tracked 13 secondary outcomes, for example Percent Change From Baseline in BMD of Total Hip at 6 Months, Percent Change From Baseline in BMD of Forearm at 6 Months, Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months, Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months, Percent Change From Baseline in Serum Osteocalcin at 6 Months and Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Abaloparatide in 250 people.

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

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