The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity (NCT07271771) | Clinical Trial Compass
RecruitingPhase 4
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
Denmark40 participantsStarted 2024-05-21
Plain-language summary
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.