The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

What Was Tested

This registered phase 2 trial tested Semaglutide for osteoporosis and bone density.

Treatment involves once daily oral GLP-1Ra semaglutide or matching placebo for 52 weeks.

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

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 64 planned participants were the target.

It was open to people of any sex aged from 50 years up to 85 years.

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

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 3 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes mellitus; congestive heart failure (nyha class iv); primary hyperparathyroidism.

How the Study Was Run

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

The osteoporosis and bone density participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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 2024-06-07 with completion listed for 2027-01-15.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Procollagen type 1 N-terminal propeptide (P1NP) (time frame: Baseline and 52 weeks).

It also tracked 18 secondary outcomes, for example Collagen 1 cross link C-terminal telopeptide (CTX), Osteocalcin, Bone specific alkaline phosphatase (BALP), Bone mineral density (BMD), Estimated bone strength and Total volumetric BMD.

What This Means in Plain Language

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

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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