The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

Recruiting · NCT07271771 · Interventional (participants receive a specific treatment) · Lead sponsor: Aarhus University Hospital

Interventions studied

DenosumabSaline (0.9% NaCl)

Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.

Age range

40 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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

1 location listed.