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New treatment option for Osteoporosis
Official title The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
ClinicalTrials.gov ID: NCT07271771
What this study is testing
What is Denosumab?
Denosumab is an investigational medicine, being studied as a potential treatment for osteoporosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.