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

Sponsor
Odense University Hospital
Study ID
NCT06050577
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • oral Semaglutide/Rybelsus — DRUG
    Weeks 1-4: 3 mg of oral semaglutide once daily. Weeks 5-52: 7 mg of semaglutide once daily as maintenance dose. Dose may be increased to 14 mg of semaglutide once daily as maintenance dose after 2 months if glucose levels are out of range.
  • Placebo — DRUG
    Weeks 1-4: 3 mg of oral placebo once daily. Weeks 5-52: 7 mg of placebo once daily as maintenance dose. Dose may be increased to 14 mg of placebo once daily as maintenance dose after 2 months if glucose levels are out of range.

Study Details

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.

Key Dates

Start date
Jun 7, 2024
Status verified
Mar 2025
Primary completion
Jan 15, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: oral Semaglutide/Rybelsus
    oral Semaglutide 7-14 mg (or highest tolerated dose) once daily for 52 weeks (incl. titration)
  • Placebo Comparator: oral Placebo
    oral Placebo 7-14 mg (or highest tolerated dose) once daily for 52 weeks (incl. titration)

Primary Outcome Measure

Procollagen type 1 N-terminal propeptide (P1NP) [ Time Frame: Baseline and 52 weeks ]

Related Studies