Denosumab effects on muscle strength and insulin sensitivity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled, prospective phase 4 trial comparing denosumab injections to saline in postmenopausal women with osteoporosis and type 2 diabetes treated with metformin. The study will measure changes in insulin sensitivity and muscle strength, with secondary measures including bone mineral density and metabolic markers related to the RANKL–osteoclast–DPP-4–GLP-1 pathway. Eligible participants are postmenopausal women aged 40 or older with a BMD T-score ≥ -2.0 and on metformin monotherapy, while key exclusions include prior osteoporosis treatment, other antidiabetic drugs, severe kidney disease, active cancer, and immobility. The trial is conducted at Aarhus University Hospital and uses standard denosumab dosing versus saline placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting

Study contacts

• Principal investigator: Bente Langdahl, MD, Professor, DMSc, PhD — Aarhus University Hospital
• Study coordinator: Anne Sophie Sølling, MD, PhD
• Email: annesoel@rm.dk
• Phone: +45 22 30 05 24

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ibandronate vs. Zoledronic Acid After Denosumab: Is Either Equal for Postmenopausal Osteoporosis?

  In postmenopausal osteoporosis, this study tests whether intravenous ibandronate given after stopping denosumab works as well as zoledronic acid over a year.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT07406685

• Romosozumab and denosumab alone or together for postmenopausal osteoporosis

  This 6-month pilot tests whether cyclic romosozumab combined with denosumab improves bone density more than denosumab alone in postmenopausal women with osteoporosis.

  Recruiting Phase 4 National Taiwan University Hospital · Douliu, Taiwan · NCT07283887

• Comparing two treatment regimens for osteoporosis in postmenopausal women

  This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT06938152

• Preventing bone loss in critically ill adults using medications

  This study is testing if two medications can help prevent bone loss in critically ill adults over 50 who have been in the ICU for more than a day.

  Recruiting at 20 sites Phase 2 Australian and New Zealand Intensive Care Research Centre · Sydney, New South Wales and 21 other locations · NCT04608630

• Evaluating new treatments for osteoporosis after denosumab therapy in Japanese patients

  This study tests different treatment options for Japanese patients with osteoporosis who have been on denosumab for two years to see which one works best and is safe to use for another two years.

  Recruiting Phase 2 Shinshu University · Matsumoto, Nagano · NCT03755193

• Role of LH and hCG in adults being evaluated for endocrine disorders

  This study looks at whether levels of luteinizing hormone (LH) and hCG in adults undergoing endocrine evaluation relate to their disease presence and outcomes.

  Recruiting Copenhagen University Hospital at Herlev · Herlev · NCT07824102

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.