Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

What Was Tested

The trial (phase 3) is built around Abaloparatide.

It had two arms (groups): abaloparatide-SC (active comparator) and abaloparatide-sMTS (experimental).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 511 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: Participants older than 65 years with BMD T score ≤ -2.0 and \> -5.0 who meet the fracture criteria may be enrolled. Participants older than 65 years with BMD T score ≤ -3.0 and \> -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA. Body mass index of 18.5 to 33 kilograms (kg)/square meters (m\^2), inclusive. Serum calcium (albumin-corrected), parathyroid hormone (1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range. Serum 25-hydroxyvitamin D values must be ≥ 20 nanograms (ng)/milliliters (mL).

The full record lists 7 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 bmd; history of bone disorders other than postmenopausal osteoporosis or a diagnosis of cancer within the last 5 years.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Abaloparatide and who got the comparison, which limits bias.

The Abaloparatide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Abaloparatide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-08-05 with completion listed for 2021-10-05.

It ran at 97 sites in United States (77), Poland (11), Hungary (5), Denmark (3) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Lumbar Spine BMD at Month 12 (time frame: Baseline, Month 12).

It also tracked 2 secondary outcomes, for example Percent Change From Baseline in Total Hip BMD at Month 12 and Percent Change From Baseline in Femoral Neck BMD at Month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Abaloparatide in 511 people.

With 511 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, all human trials.