Status:
COMPLETED
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
Lead Sponsor:
mAbxience Research S.L.
Conditions:
Postmenopausal Women With Osteoporosis
Eligibility:
FEMALE
55-80 years
Phase:
PHASE3
Brief Summary
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmen...
Detailed Description
The study was planning to randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at ...
Eligibility Criteria
Inclusion
- Postmenopausal women, diagnosed with osteoporosis.
- Aged ≥ 55 and ≤ 80 years at screening.
- Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening.
- Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by Dual-energy X-ray Absorptiometry (DXA).
- At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint evaluable by DXA.
- Adequate organ function.
Exclusion
- Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal antibody.
- History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
- Recent long bone fracture (within 6 months).
- History and/or presence of bone metastases, bone disease or other metabolic disease.
- Intravenous bisphosphonate administered within 5 years of screening.
- Oral bisphosphonates ≥12 months cumulative use prior to screening. If used \<12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled.
- Ongoing use of any osteoporosis treatment or use of prohibited treatment.
- Other bone active drugs.
- History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia.
- Other Inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT05338086
Start Date
March 16 2022
End Date
May 22 2024
Last Update
March 21 2025
Active Locations (64)
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1
AES - DRS - Medical Center Synexus Sofia EOOD
Sofia, Sofia-Grad, Bulgaria
2
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
3
Medical Center Artmed OOD
Plovdiv, Bulgaria
4
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, Bulgaria