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The Effect of Semaglutide on Bone Health

Plain-language guide to NCT07165158: phase 4 randomized trial of Semaglutide, osteoporosis and bone density, 150 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07165158
Phase
phase 4
Status
not yet recruiting
Start
2025-09-15
Completion (planned or actual)
2026-12-31
Participants
150 (estimated)
Design
randomized, double-blind, screening
Conditions studied
Osteoporosis; Osteoporosis Fracture; T2DM
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide for osteoporosis and bone density.

Therefore, the goal of this clinical trial is to learn the effect of semaglutide on bone mineral density and fractures in patients with type 2 diabetes.

It had two arms (groups): The intervention group (experimental) and The control group (no intervention).

In the intervention group, the participants will receive semaglutide combined with metformin treatment.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 50 years up to 75 years.

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

Examples of who could join: Type 2 diabetes (according to WHO diagnostic criteria),. Age range: 50 to ≦75 years,. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening,. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: bone mineral density (lumbar spine, hip, or femoral neck) t-score \< -2.5,; history of secondary osteoporosis,; history of malignant tumors,.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Neither the osteoporosis and bone density participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2025-09-15 with completion listed for 2026-12-31.

It ran at 1 site in China.

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): lumbar bone mineral density (time frame: From enrollment to the end of treatment at 12 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 150 people with osteoporosis and bone density.

Its status is not yet 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.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.