Phase 2Active, not recruiting

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

The Effect of Oral Semaglutide on Bone Turnover in Patients With Type 2 Diabetes: a Randomized Placebo-controlled Clinical Trial - (SOBER II)

Sponsor
Odense University Hospital (Academic or other)
Enrolment
64 planned
Conditions
Type 2 Diabetes; Osteopenia
Interventions
oral Semaglutide/Rybelsus; Placebo
Ages
adults, older adults
Registry
NCT06050577

From the registry

The hypothesis for this study is that oral Semaglutide, a GLP-1Ra, 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 50-85 years with type 2 diabetes and an increased risk of bone fractures. 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.

Primary outcomes

  • Procollagen type 1 N-terminal propeptide (P1NP)
Full record on ClinicalTrials.gov