Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

What Was Tested

The trial (phase 1) is built around Abaloparatide for osteoporosis and bone density.

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

It had 1 arm (groups): abaloparatide-sMTS (experimental).

The registry classes the interventions as combination product.

Who Took Part

22 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: Postmenopausal for at least 2 years. BMD T-score based on the female reference range \<-1.0 and \>-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA). Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone. Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: history of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine; history of bone disorders other than postmenopausal osteoporosis (such as paget's disease); history of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin).

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Abaloparatide study: the osteoporosis and bone density participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-04-09 with completion listed for 2019-05-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 (time frame: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29). Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29 (time frame: 0 (predose) and 4 hours postdose on Day 29).

It also tracked 4 secondary outcomes, for example Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29, Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29, Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 and Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Abaloparatide in 22 people with osteoporosis and bone density.

Its size is small, so on its own it can only give an early look.

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

More context: the Abaloparatide compound page, Osteoporosis and bone density research.