Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Eligibility
Sex
FEMALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Insulin sensitivity: HbA1c — 12 months Changes in Hb1Ac (mmol/mol) from baseline to month 12
Insulin sensitivity: HOMA-IR — 12 months Changes in HOMA-IR from baseline to month 12
Insulin sensitivity: fasting glucose — 12 months Changes in fasting glucose (mmol/l) from baseline to month 12
Insulin sensitivity: oral glucose tolerance test — 12 months Changes in oral glucose tolerance test (OGTT) (mmol/l) from baseline to month 12
Muscle mass — 12 months Changes in muscle mass (kg) from baseline to month 12.
Muscle strength — 12 months Changes in muscle strength (N) from baseline to month 12.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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