OsteoporosisPhase 3NCT06504966
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
A Phase 3 study testing MAB-22 and Prolia® in people with Osteoporosis, run by Xentria, Inc..
Trial summary
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- MAB-22 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained before participation in the study.
- Postmenopausal women diagnosed with osteoporosis (consistent with a lumbar spine bone mineral density (LS-BMD) [L1-L4] or TH-BMD T-score of ≤ -2.5 and ≥ -4.0 as measured by dual x-ray absorptiometry (DXA) at screening). Postmenopausal status is defined as at least 12 consecutive months of amenorrhea before date of screening, for which there is no other obvious pathological or physiological cause.
- Between ≥55 and ≤80 years of age at screening.
- Body weight ≥50 kg and ≤90 kg at screening.
- At least 3 vertebrae in the L1-L4 region (vertebrae to be assessed by local reading of lateral spine x-ray at screening) and at least one hip joint are evaluable by DXA.
- Adequate organ function as defined by the following criteria:
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- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN).
- Total serum bilirubin ≤1.5 × ULN.
- Absolute neutrophil count ≥1500 cells/μL (SI units: ≥1.5 × 109/L).
- Platelet count ≥100,000 cells/μL (SI units: ≥100 × 109/L) and ≤ULN.
- Hemoglobin ≥10 g/dL and ≤ULN.
- Albumin-adjusted serum calcium within the normal range for the testing laboratory.
- Estimated glomerular filtration rate >45 mL/min.
Who cannot join
- Previous exposure to denosumab (Prolia®, Xgeva®, or biosimilar denosumab).
- History of hypersensitivity to any recombinant protein drugs or any of the excipients used in MAB-22 or Prolia®.
- History and/or presence of 1 severe or more than 2 moderate vertebral fractures or hip fractures (as determined by local reading of lateral spine x-ray at screening). Osteoporotic-related fracture (i.e., crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 6 months of randomization.
- Recent long bone fracture (within 6 months) before screening. Presence of active healing fracture according to assessment of investigators.
- History and/or presence of bone metastases, bone disease, or metabolic disease, other than osteoporosis, which could interfere with the interpretation of the findings (e.g., osteogenesis imperfecta, osteopetrosis, osteomalacia, rheumatoid arthritis, Paget's disease, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, malabsorption syndrome, hypoparathyroidism or hyperparathyroidism [irrespective of current controlled or uncontrolled status], hypocalcemia or hypercalcemia [based on albumin-adjusted serum calcium]).
- Malignancy within the 5 years before screening (except cervical carcinoma in situ or basal cell carcinoma, which are acceptable).
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- Ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements). The following rules for washout periods for osteoporosis treatments must be adhered to:
- Drugs being investigated for osteoporosis (e.g., romosozumab): dose received at any time.
- Strontium or fluoride (for osteoporosis): dose received at any time.
- Tibolone, oral or transdermal estrogen, selective estrogen receptor modulators, systemic hormone replacement therapy: dose received within 12 months before screening.
- Calcitonin, calcitriol, maxacalcitol, falecalcitriol, or alfacalcidol: dose received within 3 months before screening.
- Cinacalcet: dose received within 3 months before screening.
- Any oral bisphosphonate treatment. Note: those participants who have taken oral bisphosphonates for up to 3 months, or >3 months but <3 years cumulatively are eligible after a 12-month washout period.
- Intravenous bisphosphonates: dose received within 5 years before the first administration of study treatment.
- Parathyroid hormone (PTH), or PTH derivatives within the last 12 months before the first administration of study treatment.
- Other bone active drugs including heparin, anti-convulsives (with the exception of benzodiazepines), systemic ketoconazole, adrenocorticotropic hormone, lithium, gonadotropin releasing hormone agonists, and anabolic steroids, within the past 3 months before the first administration of study treatment.
- Systemic glucocorticosteroids (≥5 mg prednisone equivalent per day for ≥10 days or a total cumulative dose of ≥50 mg) within the past 3 months before screening.
- Use of other investigational drugs within 2 months of screening (or 5 half-lives of the drug or until the expected Pharmacodynamic (PD) effect of the drug has returned to baseline, whichever is longer) or longer if required by local regulations.
- Oral or dental conditions: osteomyelitis or history and/or presence of osteonecrosis of the jaw (ONJ), presence of risk factors for ONJ (e.g., periodontal disease, poorly fitting dentures, invasive dental procedures such as tooth extractions in 6 months before screening), active dental or jaw condition which requires oral surgery and/or planned invasive dental procedure.
- Recent tooth extraction (within 6 months of the screening visit). Edentulous participants are permitted to enroll in the study, as long as the most recent tooth extraction occurred >6 months of the screening visit.
- Vitamin D deficiency (25-[OH] vitamin D serum level <20 ng/mL). Vitamin D repletion is permitted at the discretion of the investigator, and participants will be rescreened to reevaluate vitamin D level post-repletion.
- Known intolerance to, or malabsorption of calcium or vitamin D supplements.
- History and/or presence of a severe allergic reaction (e.g., anaphylaxis).
- Has a hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody positive at screening.
- History and/or presence of significant cardiac disease as per investigator's discretion, including but not restricted to: Electrocardiogram (ECG) abnormalities at screening indicating significant risk of safety for participants participating in the study, history and/or presence of myocardial infarction within 6 months before screening, history and/or presence of New York Heart Association (NYHA) class III or IV heart failure.
- History of prior allogeneic transplantation.
- Have a history of alcohol or drug abuse in the judgment of the investigator within the previous 12 months before screening.
- Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
- Have major surgery (including surgery to bone), or significant traumatic injury occurring within 4 weeks before randomization.
About this study
Official title: A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
Read the detailed description
A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced from the European Union in Postmenopausal Women with Osteoporosis
- Conditions
- Osteoporosis
- Being tested
- MAB-22, Prolia®
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAB-22Drug
Single subcutaneous dose of 60 mg
Prolia®Drug
Single subcutaneous dose of 60 mg
| Study group | Role | What they receive |
|---|---|---|
| MAB-22 | Experimental | Single subcutaneous dose at Day 1 (baseline), 6 months (Week 26) and Visit 12 (Week 52) Receives: Drug: MAB-22 |
| Prolia® and MAB-22 | Experimental | Single subcutaneous dose of Prolia® at Day 1 (baseline), 6 months (Week 26) and single subcutaneous dose of MAB-22 (switching) or Prolia ® (non-switching) at Visit 12 (Week 52) Receives: Drug: MAB-22; Drug: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to efficacy profile in terms of bone mineral density (BMD).
Efficacy coprimary endpoint: percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) (LS-BMD)
Measured: Day 1 to Week 52
To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to Pharmacodynamic (PD) profile in terms of serum cross-linked C telopeptide of type I collagen (sCTX).
PD coprimary endpoint: area under the effect curve (AUEC) of C telopeptide of type I collagen (sCTX) over the initial 6-month period
Measured: Day 1 to Week 26 [Predose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: Business decision not to proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504966
- Sponsor's protocol ID
- MAB-22-301
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT06504966
- Acronym / sponsor ID
- MAB-22-301
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision not to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
Detailed description
A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced from the European Union in Postmenopausal Women with Osteoporosis
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAB-22 | Experimental | Drug: MAB-22Single subcutaneous dose at Day 1 (baseline), 6 months (Week 26) and Visit 12 (Week 52) |
| Prolia® and MAB-22 | Experimental | Drug: MAB-22, Drug: Prolia®Single subcutaneous dose of Prolia® at Day 1 (baseline), 6 months (Week 26) and single subcutaneous dose of MAB-22 (switching) or Prolia ® (non-switching) at Visit 12 (Week 52) |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent must be obtained before participation in the study.
- Postmenopausal women diagnosed with osteoporosis (consistent with a lumbar spine bone mineral density (LS-BMD) [L1-L4] or TH-BMD T-score of ≤ -2.5 and ≥ -4.0 as measured by dual x-ray absorptiometry (DXA) at screening). Postmenopausal status is defined as at least 12 consecutive months of amenorrhea before date of screening, for which there is no other obvious pathological or physiological cause.
- Between ≥55 and ≤80 years of age at screening.
- Body weight ≥50 kg and ≤90 kg at screening.
- At least 3 vertebrae in the L1-L4 region (vertebrae to be assessed by local reading of lateral spine x-ray at screening) and at least one hip joint are evaluable by DXA.
Key exclusion criteria (29 listed)
- Previous exposure to denosumab (Prolia®, Xgeva®, or biosimilar denosumab).
- History of hypersensitivity to any recombinant protein drugs or any of the excipients used in MAB-22 or Prolia®.
- History and/or presence of 1 severe or more than 2 moderate vertebral fractures or hip fractures (as determined by local reading of lateral spine x-ray at screening). Osteoporotic-related fracture (i.e., crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 6 months of randomization.
- Recent long bone fracture (within 6 months) before screening. Presence of active healing fracture according to assessment of investigators.
- History and/or presence of bone metastases, bone disease, or metabolic disease, other than osteoporosis, which could interfere with the interpretation of the findings (e.g., osteogenesis imperfecta, osteopetrosis, osteomalacia, rheumatoid arthritis, Paget's disease, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, malabsorption syndrome, hypoparathyroidism or hyperparathyroidism [irrespective of current controlled or uncontrolled status], hypocalcemia or hypercalcemia [based on albumin-adjusted serum calcium]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAB-22Single subcutaneous dose of 60 mg | Drug | MAB-22, Prolia® and MAB-22 |
| Prolia®Single subcutaneous dose of 60 mg | Drug | Prolia® and MAB-22 |
Primary outcome
To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to efficacy profile in terms of bone mineral density (BMD).
Time frame: Day 1 to Week 52
Efficacy coprimary endpoint: percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) (LS-BMD)
To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to Pharmacodynamic (PD) profile in terms of serum cross-linked C telopeptide of type I collagen (sCTX).
Time frame: Day 1 to Week 26 [Predose]
PD coprimary endpoint: area under the effect curve (AUEC) of C telopeptide of type I collagen (sCTX) over the initial 6-month period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MAB-22 and Prolia® in people with Osteoporosis, run by Xentria, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to efficacy profile in terms of bone mineral density (BMD). (time frame: Day 1 to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.