The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture

What Was Tested

The trial (phase 1, phase 2) is built around Semaglutide for osteoporosis and bone density.

The effect will be measured by bone markers in blood samples, bone scans, bone tissue tests (bone biopsy), and direct bone strength measured by microindentation at the start and end of the study.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

64 planned participants were the target.

It was open to people of any sex aged from 40 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: T-score \<-1 in hip or lower back, assessed by DXA scan and / or. Low-energy fracture within the last 3 years.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: diabetes type 1 and 2; heart failure similar to nyha class iv; primary hyperparathyroidism.

How the Study Was Run

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

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

Groups ran in parallel: each of the osteoporosis and bone density participants stayed in one arm throughout.

As a double-blind Semaglutide 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 2021-03-24 with completion listed for 2022-08-31.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Procollagen type 1 N-terminal propeptide (P1NP) (time frame: Baseline and 52 weeks).

It also tracked 15 secondary outcomes, for example Collagen 1 cross link C-terminal telopeptide (CTX), Tartrate-resistant acid phosphatase (TRAP), Osteocalcin, Bone specific alkaline phosphatase (BALP), BMSi and Bone mineral density (BMD).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Semaglutide in 64 people with osteoporosis and bone density.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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