NCT07271771 The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
| NCT ID | NCT07271771 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aarhus University Hospital |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-05-21 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Eligibility Criteria
Inclusion Criteria: * Postmenopausal women (postmenopausal for at least two years) * Age ≥ 40 years * BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck) * At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA) * Diabetes Mellitus type 2 * Treatment with metformin as monotherapy Exclusion Criteria: * Treatment for osteoporosis at any time * Other antidiabetic medication than metformin * Low-energy vertebral fractures at any time * Low-energy hip fracture at any time * Ongoing treatment with systemic glucocorticoids * Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism) * Treatment affecting bone, calcium metabolism or muscle * Active cancer within the last 5 years with the exception of basal cell skin cancer * Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min * Unable to read and understand Danish * Immobility
Contact & Investigator
Bente Langdahl, MD, Professor, DMSc, PhD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT07271771 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07271771 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07271771 currently recruiting?
Yes, NCT07271771 is actively recruiting participants. Contact the research team at annesoel@rm.dk for enrollment information.
Where is the NCT07271771 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT07271771 clinical trial?
NCT07271771 is sponsored by Aarhus University Hospital. The principal investigator is Bente Langdahl, MD, Professor, DMSc, PhD at Aarhus University Hospital. The trial plans to enroll 40 participants.