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

1 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik Bialystok Poland
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Diagnostic Consulting Center XVII Sofia Ltd. Sofia Bulgaria
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Synexus Czech s.r.o. Prague Czechia
Rcmed Oddzial Sochaczew Sochaczew Poland
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
Solumed Sp. z o.o. sp.k. Poznan Poland
Mbal Lyulin EAD Sofia Bulgaria
Medical Centre Synexus Sofia EOOD Sofia Bulgaria
Medical Plus s.r.o. Uherske Hradiste Czechia
Ambulatorium Sp. z o.o. Elblag Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Synexus Polska Sp. z o.o. Poznan Poland
Somed Cr Sp. z o.o. sp.k. Lodz Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Mujsbphsk Ihjclhtnnr Cbkblrbx Sssnbjli Sjl z owqv Warsaw Poland
Mhqayak Cxrglh Hqanpohy 2iji Oty Haskovo Bulgaria
Gyyskkv Dgziuzkbjev i Lxnjzkfm Orclwvgjqmr Wtgwqeqf Pfgeraqeyju Gliwice Poland
G Ccodpdo Offmtka sizarj Olomouc Czechia
Sqawsjrkfgj Pomswkoro Zkirej Oygjgl Ziqqjkmsnf w Tkvnjbwmes Llwnduauc Tomaszow Lubelski Poland
Axcwekhso sdonnx Trebovice Czechia
Dasiercbdr Cioivytrsqws Cthslt Eipsqo Osc Varna Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
28.10.2024
Czechia Czechia
Not recruiting
28.10.2024
Poland Poland
Not recruiting
28.10.2024

Trial locations

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.

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 ID:
2024-512417-41-00
Protocol code:
MAB-22-301
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effects of Stopping Alendronic Acid in Patients with Osteoporosis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Denmark
  • Study on Zoledronic Acid Following Denosumab for Osteoporosis Patients

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark