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Study Comparing MAB-22 and Denosumab for Treating Osteoporosis in Postmenopausal Women

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What is this trial about?

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

This clinical trial is focused on studying osteoporosis, a condition that weakens bones, making them fragile and more likely to break. The study will compare two treatments: MAB-22 and Prolia, both of which contain the active substance denosumab. Denosumab is a type of protein used to help strengthen bones. The purpose of the study is to see if MAB-22 works as well as Prolia in treating osteoporosis in postmenopausal women.

Participants in the study will receive either MAB-22 or Prolia through a subcutaneous injection, which means the medicine is given under the skin using a pre-filled syringe. The study will last for a period of time, during which the effects of the treatments on bone health will be monitored. This includes looking at changes in bone mineral density, which is a measure of bone strength, and other markers in the blood that indicate bone health.

The study will also assess the safety of the treatments by monitoring any side effects or adverse reactions that may occur. Additionally, the study will look at how the body processes the medication, known as pharmacokinetics, and how the medication affects the body, known as pharmacodynamics. The goal is to ensure that MAB-22 is as effective and safe as Prolia for women with osteoporosis. Participants will be closely monitored throughout the study to ensure their well-being and to gather important data on the treatments' effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either MAB-22 or Prolia (60 mg solution for injection).

    The study is designed to compare the effects of these two treatments in postmenopausal women with osteoporosis.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate bone mineral density (BMD) using a scan called DXA, which measures bone density.

    Blood tests will be performed to check various health parameters, including liver function and calcium levels.

  3. Step 3

    Treatment administration

    The treatment involves a subcutaneous injection of the assigned medication every six months.

    The first injection will be administered at the start of the study, with subsequent injections at six-month intervals.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will occur at Weeks 26, 52, and 78 to monitor changes in bone mineral density and other health indicators.

    Blood samples will be collected to measure levels of specific markers related to bone health and to check for any immune response to the medication.

  5. Step 5

    Safety monitoring

    Throughout the study, participants will be monitored for any side effects or adverse reactions to the treatment.

    Regular check-ups will include physical examinations, blood tests, and heart monitoring using an ECG.

  6. Step 6

    Study completion

    The study is expected to conclude in October 2026.

    Final assessments will be conducted to evaluate the overall effects of the treatment on bone health and safety.

Who can join the trial?

13 criteria

  • You must sign a form agreeing to participate in the study.
  • You need to be a postmenopausal woman diagnosed with **osteoporosis**. This means your bone density is lower than normal, as measured by a special scan called **DXA**.
  • You should be between 55 and 80 years old.
  • Your body weight should be between 50 kg and 90 kg.
  • You must have at least 3 vertebrae in the lower spine and at least one hip joint that can be checked by the DXA scan.
  • Your organs need to be working well, which is checked by several blood tests:
  • **AST** and **ALT** are liver enzymes, and their levels should not be more than 2.5 times the normal limit.
  • **Total serum bilirubin** should not be more than 1.5 times the normal limit.
  • **Absolute neutrophil count** should be at least 1500 cells per microliter.
  • **Platelet count** should be at least 100,000 cells per microliter and not above the normal limit.
  • **Hemoglobin** should be at least 11 grams per deciliter and not above the normal limit.
  • **Albumin-adjusted serum calcium** should be within the normal range.
  • **Estimated glomerular filtration rate** should be more than 45 milliliters per minute, which checks how well your kidneys are working.

Who cannot join the trial?

4 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are not postmenopausal women cannot participate. This means women who have not yet gone through menopause are excluded.
  • People who do not have **osteoporosis** cannot participate. Osteoporosis is a condition where bones become weak and are more likely to break.
  • Individuals who are considered part of a **vulnerable population** cannot participate. This generally refers to groups who may need special protection or care.
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Investigated drugs

  • MAB-22

    is a medication being tested in this clinical trial to see if it works similarly to another treatment for osteoporosis. It is being studied to understand how well it can help improve bone mineral density in postmenopausal women. The trial also looks at how the body processes and responds to this medication.

  • Prolia

    is a medication already used in the European Union to treat osteoporosis in postmenopausal women. It helps to increase bone mineral density and reduce the risk of fractures. In this trial, Prolia is used as a comparison to see if MAB-22 works just as well.

What is already known about the treatment

  • Prolia

    Prolia is administered via subcutaneous injection and is primarily used to treat osteoporosis, particularly in postmenopausal women. It is well-established in medical literature as an effective treatment for increasing bone mineral density and reducing the risk of fractures. The medication works by inhibiting a protein involved in bone resorption, thereby slowing down the breakdown of bone. Prolia is classified as a monoclonal antibody and is widely recognized for its role in managing osteoporosis.

  • MAB-22

    MAB-22 is administered through subcutaneous injection and is currently being studied for its potential to treat osteoporosis in postmenopausal women. It is in clinical trials to assess its biosimilarity to Prolia, focusing on its efficacy in improving bone mineral density and its pharmacodynamic effects on bone turnover markers. MAB-22 is designed to work by targeting the same protein as Prolia, aiming to slow bone resorption. It is classified as a monoclonal antibody and is under investigation to confirm its therapeutic potential in osteoporosis management.

Investigated diseases

Osteoporosis – Osteoporosis is a condition characterized by weakened bones, making them more fragile and prone to fractures. It occurs when the creation of new bone doesn't keep up with the removal of old bone. This disease often progresses silently over many years, with no symptoms until a fracture occurs. Common fracture sites include the hip, wrist, and spine. As the disease advances, individuals may experience a decrease in height and a stooped posture. It is most commonly seen in postmenopausal women due to hormonal changes that affect bone density.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512417-41-00Protocol codeMAB-22-301Estimated enrolment440 patientsSponsorXentria Inc.

sourced from the EU Clinical Trials Register and site verification

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