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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 15, 2026 → Jan 15, 2027
See other at-risk trials from Odense University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
  2. Primary completion pushed from Jan 15, 2026 to Jan 15, 2027 Show 4 more changesShow less
    • Study completion pushed from Jan 15, 2027 to Mar 15, 2027
    • Interventions: Placebo (Drug), oral Semaglutide/Rybelsus (Drug) to Placebo (Drug), oral Semaglutide/Rybelsus (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 18 entries
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Nov 2025 to Jan 15, 2026
    • Study completion date: Nov 2025 to Jan 15, 2027
    • Site details revised
    v4
  4. Start date changed from estimate of Jun 2024 to Jun 7, 2024v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2023 to Jun 2024
    • Secondary endpoints: 19 to 18
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06050577
Lead Sponsor Odense University Hospital
Conditions
(from sponsor)		 Type 2 Diabetes, Osteopenia
Related terms Bone Diseases, Metabolic, Diabetes Mellitus, Type 2
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov