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Study of Denosumab Effects on Muscle Strength and Insulin Sensitivity in Patients with Postmenopausal Osteoporosis and Diabetes Mellitus

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying the effects of denosumab in patients with Type 2 Diabetes Mellitus and postmenopausal osteoporosis. Denosumab is a human monoclonal antibody that is being investigated to understand how it affects muscle strength and the body's response to insulin. The medication will be administered through subcutaneous injection, which means it is given as a shot under the skin.

The study will compare denosumab with placebo to determine its effectiveness. Participants will receive either 60 mg of denosumab or saline solution (salt water) injections. The purpose of this research is to evaluate how denosumab influences muscle mass, strength, and how well the body processes insulin in postmenopausal women who have both diabetes and bone health concerns.

The treatment period will last for 12 months, during which various measurements will be taken to track changes in muscle strength and the body's response to insulin. Throughout the study, participants will undergo regular check-ups to monitor their progress and any changes in their condition. The study will measure several factors related to bone health, muscle function, and blood sugar control to better understand how the medication works.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and measurements

    The study begins with measuring your bone density using a special X-ray scan called DXA

    Your blood sugar levels will be tested through various methods including fasting glucose and glucose tolerance test

    Initial measurements of your muscle mass and muscle strength will be taken

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either denosumab or saline (inactive substance)

    Both medications will be given as an injection under the skin (subcutaneous injection)

  3. Step 3

    Follow-up at 1 month

    Your muscle strength will be measured

    Blood tests will be performed to check your blood sugar control

  4. Step 4

    Follow-up at 3 months

    Another set of muscle strength measurements will be taken

    Additional blood sugar control tests will be conducted

  5. Step 5

    Final assessment at 12 months

    Final measurements of your muscle mass and strength will be taken

    Comprehensive blood tests will be performed to assess blood sugar control

    Bone density will be measured again using DXA scan

    Additional blood markers related to bone health will be tested

Who can join the trial?

6 criteria

  • You must be a woman who has gone through menopause (no menstrual periods for at least two years)
  • You must be 40 years of age or older
  • Your bone density measurement (T-score) must be -2.0 or higher when measured at your lower spine, hip area, or upper thigh bone. This is measured using a special X-ray test
  • You must have at least 2 vertebrae (bones in your lower back) that can be properly examined using a special type of X-ray called DXA (a low-radiation scan that measures bone density)
  • You must have been diagnosed with Type 2 Diabetes (a condition where your body has trouble controlling blood sugar levels)
  • You must be currently taking only metformin (a common diabetes medication) as your diabetes treatment, with no other diabetes medications

Who cannot join the trial?

14 criteria

  • Male individuals (only females can participate)
  • People under 18 or over 65 years of age
  • Individuals who do not have both diabetes mellitus (high blood sugar condition) and postmenopausal osteoporosis (bone loss after menopause)
  • Pregnant or breastfeeding women
  • Persons belonging to vulnerable populations (such as those unable to give informed consent)
  • Individuals with severe kidney disease
  • People with active infections
  • Those who have participated in another clinical trial within the past 30 days
  • Individuals with known allergies to the study medication or its components
  • People with uncontrolled high blood pressure
  • Those with severe liver problems
  • Individuals with blood clotting disorders
  • People with a history of severe allergic reactions
  • Those currently using medications that could interact with the study drug
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Investigated drugs

Denosumab is a medication that works by blocking a protein involved in bone loss. It is commonly used to treat osteoporosis and prevent bone-related complications. In this trial, researchers are studying how this medication might affect muscle strength and how the body processes insulin (insulin sensitivity). It is given as an injection under the skin.

What is already known about the treatment

Denosumab - A subcutaneously administered monoclonal antibody medication that works by inhibiting RANK ligand, a protein essential for the formation and function of bone-dissolving cells called osteoclasts. This medication is primarily used for treating postmenopausal osteoporosis and is classified as a bone metabolism regulator. Denosumab helps prevent bone loss by decreasing bone breakdown, increasing bone density, and reducing the risk of fractures, while recent clinical trials are also investigating its potential effects on muscle strength and insulin sensitivity in patients with diabetes mellitus. The medication is typically administered as an injection under the skin every six months in a healthcare setting.

Investigated diseases

  • Diabetes Mellitus

    A chronic metabolic disorder characterized by high blood sugar levels due to the body's inability to produce enough insulin or use it effectively. The condition affects how the body processes glucose, which is vital for energy production in cells. Over time, the pancreas may produce less insulin, or body cells become resistant to insulin's effects. The disease can develop gradually, often with subtle initial symptoms such as increased thirst, frequent urination, and fatigue.

  • Postmenopausal Osteoporosis

    A condition that occurs in women after menopause, characterized by decreased bone density and increased bone fragility. The condition develops when bone breakdown occurs faster than bone formation, leading to progressive loss of bone mass. This process accelerates after menopause due to decreased estrogen levels. The bones become more porous and weaker over time, making them more susceptible to structural changes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510637-18-00Estimated enrolment40 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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