Actively Recruiting

Phase 4
Age: 40Years +
FEMALE
NCT07271771

The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

Led by Aarhus University Hospital · Updated on 2025-12-15

40

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

S

Sponsor: MD, Professor, DMSc, PhD Bente Lomholt Langdahl

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

Who Can Participate

Age: 40Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women (postmenopausal for at least two years)
  • Age 40 years or older
  • Bone mineral density (BMD) T-score of -2.0 or higher at lumbar spine, total hip, or femoral neck
  • At least 2 lumbar vertebrae evaluable by dual-energy x-ray absorptiometry (DXA)
  • Diagnosis of type 2 diabetes mellitus
  • Treatment with metformin as the only diabetes medication
Not Eligible

You will not qualify if you...

  • Any previous treatment for osteoporosis
  • Use of antidiabetic medications other than metformin
  • History of low-energy vertebral fractures
  • History of low-energy hip fractures
  • Current treatment with systemic glucocorticoids
  • Presence of other metabolic bone diseases (e.g., osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism)
  • Treatments affecting bone, calcium metabolism, or muscle
  • Active cancer within the last 5 years except basal cell skin cancer
  • Estimated glomerular filtration rate (eGFR) of 35 mL/min or less
  • Inability to read and understand Danish
  • Immobility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark

Actively Recruiting

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Research Team

A

Anne Sophie Sølling, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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