Denosumab effects on muscle strength and insulin sensitivity
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
This trial will test whether denosumab improves muscle strength and insulin sensitivity in postmenopausal women with osteoporosis and type 2 diabetes who are taking metformin.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT07271771 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled, prospective phase 4 trial comparing denosumab injections to saline in postmenopausal women with osteoporosis and type 2 diabetes treated with metformin. The study will measure changes in insulin sensitivity and muscle strength, with secondary measures including bone mineral density and metabolic markers related to the RANKL–osteoclast–DPP-4–GLP-1 pathway. Eligible participants are postmenopausal women aged 40 or older with a BMD T-score ≥ -2.0 and on metformin monotherapy, while key exclusions include prior osteoporosis treatment, other antidiabetic drugs, severe kidney disease, active cancer, and immobility. The trial is conducted at Aarhus University Hospital and uses standard denosumab dosing versus saline placebo.
Who should consider this trial
Good fit: Postmenopausal women aged 40 or older with type 2 diabetes on metformin alone, a BMD T-score ≥ -2.0, ability to read Danish, and no prior osteoporosis treatment are the intended participants.
Not a fit: Patients unlikely to receive benefit include those using other antidiabetic medications, with prior osteoporosis treatments or low-energy fractures, severe renal impairment (eGFR ≤ 35 mL/min), active recent cancer, or those who are immobile or cannot read Danish.
Why it matters
Potential benefit: If successful, denosumab could improve insulin sensitivity and muscle strength in this patient group, potentially improving diabetes control and physical function.
How similar studies have performed: Animal models and small human studies have suggested metabolic benefits of denosumab, but larger clinical data are limited and results to date have been inconsistent.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Bente Langdahl, MD, Professor, DMSc, PhD — Aarhus University Hospital
- Study coordinator: Anne Sophie Sølling, MD, PhD
- Email: annesoel@rm.dk
- Phone: +45 22 30 05 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.