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Clinical Trial Details

Trial ID: L7126
Source ID: NCT06050577
Associated Drug: Oral Semaglutide/Rybelsus
Title: The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Osteopenia
Interventions: DRUG: oral Semaglutide/Rybelsus|DRUG: Placebo
Outcome Measures: Primary: Procollagen type 1 N-terminal propeptide (P1NP), Percentage changes in bone formation marker P1NP from baseline and after 12 months, Baseline and 52 weeks | Secondary: Collagen 1 cross link C-terminal telopeptide (CTX), Changes in bone resorption marker CTX from baseline and after 12 months, Baseline and 52 weeks|Osteocalcin, Changes in bone formation marker osteocalcin from baseline and after 12 months, Baseline and 52 weeks|Bone specific alkaline phosphatase (BALP), Changes in bone formation marker BALP from baseline and after 12 months, Baseline and 52 weeks|Bone mineral density (BMD), Changes in BMD (total hip, femoral neck and lumbar spine (L1-4)) assessed by DXA scans from baseline and after 12 months, Baseline and 52 weeks|Estimated bone strength, Changes in estimated bone strength assessed by finite elemental analysis (HR-pQCT scan) from baseline and after 12 months, Baseline and 52 weeks|Total volumetric BMD, Changes in total volumetric BMD (mg/cm\^3) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Trabecular volumetric BMD, Changes in trabecular volumetric BMD (mg/cm\^3) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Cortical volumetric BMD, Changes in cortical volumetric BMD (mg/cm\^3) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Bone volume, Changes in trabecular bone volume pr total volume (BV/TV) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Trabecular thickness, Changes in trabecular thickness (mm) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Cortical thickness, Changes in cortical thickness (mm) assessed by HR-pQCT scan of distal tibia and radius, Baseline and 52 weeks|Cortical porosity, Changes in cortical porosity assessed by HR-pQCT scan of tibia and radius, Baseline and 52 weeks|Bone formation rate, Changes in bone formation rate (BRF/BS, µm\^3/µm\^2 per day), the volume of mineralized bone made per unit surface of bone per year, based on dynamic histomorphometry of bone tissue, 52 weeks|Fat tissue distribution, Change in fat tissue distribution, assessed by DXA, Baseline and 52 weeks|Lean tissue distribution, Change in lean tissue distribution, assessed by DXA, Baseline and 52 weeks|Glycosylated haemoglobin (HbA1C), Change in HbA1c from baseline and after 12 months, Baseline and 52 weeks|Physical activity, Change in physical activity based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF) from baseline and after 12 months, Baseline and 52 weeks|Body mass index (BMI), Change in BMI from baseline and after 12 months, Baseline and 52 weeks | Other: Osteogenic potential, Change in osteogenic potential, i.e., ability to form new bone, assessed using spatial transcriptomics and single-cell RNA sequencing., 52 weeks
Sponsor/Collaborators: Sponsor: Odense University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2025-11
Results First Posted:
Last Update Posted: 2025-03-30
Locations: Odense University Hospital, Odense, 5000, Denmark
URL: https://clinicaltrials.gov/show/NCT06050577