Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

What Was Tested

This registered phase 3 trial tested Abaloparatide for osteoporosis and bone density.

The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.

It had 1 arm (groups): Abaloparatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Transiliac bone biopsies were taken at 3 months after quadruple fluorochrome labeling.

The treatment duration of 3 months was determined to be the optimal time when biochemical markers of bone turnover peak and are predictive of subsequent changes in bone mineral density (BMD).

The main study was conducted for a 3-month treatment period with a 1-month follow up.

Who Took Part

23 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: The participant has read, understood, and signed the written informed consent form.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: unevaluable hip bmd or participants who have undergone bilateral hip replacement (unilateral hip replacement is acceptable); history of bone disorders (for example, paget's disease) other than postmenopausal osteoporosis; unexplained elevation of serum alkaline phosphatase.

How the Study Was Run

Design: single-group and open-label.

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.

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

It started in 2018-09-20 with completion listed for 2020-07-15.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3 (time frame: Baseline (Day 1), Month 3).

It also tracked 3 secondary outcomes, for example Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3, Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3 and Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Abaloparatide in 23 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.