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

Summary

The hypothesis for this study is that the GLP-1Ra Semaglutide has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 40-85 years at increased risk of bone fractures. Treatment involves injection of Semaglutide 1.34 mg/ml once a week or corresponding volume of placebo once a week for 52 weeks. 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.

Timeline

Start

2021-03-24

Primary completion

2022-08-31

Completion

2022-08-31

Outcome

Missed primary endpoint

paper estimated treatment difference (ETD) semaglutide versus placebo 3.8 μg/L [95% CI -5.6 to 13.3]; p = 0.418 PMID 38737002 ↗

paper There was no effect on changes in P-PINP from baseline to week 52 between the two groups PMID 38737002 ↗

Publications

• Hansen MS, Wolfel EM, Jeromdesella S, Moller JK, Ejersted C, Jorgensen NR, Eastell R, Hansen SG, Frost M. Once-weekly semaglutide versus placebo in adults with increased fracture risk: a randomised, double-blinded, two-centre, phase 2 trial. EClinicalMedicine. 2024 May 3;72:102624. doi: 10.1016/j.eclinm.2024.102624. eCollection 2024 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Semaglutide	Peptide	1 mg	Subcutaneous

Indications

No indication recorded.