NCT04702516

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

The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Morten Frost · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Ozempic	2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.
DRUG	Placebo	2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.

Timeline

• Start date: 2021-03-24
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-01-11
• Last updated: 2021-03-30

Locations

1 site across 1 country: Denmark