RecruitingPhase 4NCT07271771

The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

Sponsor

Aarhus University Hospital

Enrollment

40 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Osteoporosis

Summary

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

Eligibility

Sex: FEMALEMin Age: 40 Years

Inclusion Criteria6

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 Criteria11

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

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Interventions

DRUGDenosumab

Denosumab 60 mg

DRUGSaline (0.9% NaCl)

Placebo

Locations(1)

Aarhus University Hospital

Aarhus, Denmark

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NCT07271771

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