Efficacy, safety, PK, PD, and immunogenicity of BP16 in post-menopausal osteoporosis
Key facts
- Where
- Balatonfüred, Budapest, Budapest III és Zalaegerszeg, MagyarországSee the 4 sites
- Phase
- 3. fázis
Where in Magyarország
- DRC Kft.Balatonfüred, MagyarországNo longer taking part
- Qualiclinic Kft.Budapest, MagyarországNo longer taking part
- SYNEXUS Magyarorszag Kft.Budapest III, MagyarországNo longer taking part
- Obudai Egeszsegugyi Centrum KftZalaegerszeg, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Curateq Biologics Private Limited
- Trial code
- EU 2023-503790-37-00
- Record updated
- 2025. november 5.
- Original description
1. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of change in BMD at Week 52. 2. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of area under the effect curve (AUEC) in serum C-telopeptide (sCTX) up to Week 26Read full original descriptionShow less
A Phase III, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of BP16 Versus EU-Prolia® in Women with Post- Menopausal Osteoporosis
1. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of change in BMD at Week 52. 2. To demonstrate therapeutic and PD equivalence between BP16 and EU-Prolia in terms of area under the effect curve (AUEC) in serum C-telopeptide (sCTX) up to Week 26
Inclusion: Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the investigator; Post-menopausal women with age between 55 and 80 years (both inclusive) at screening visit; Evidence of osteoporosis as assessed by LS absolute BMD corresponding to T-score of -2.5 and -4.0 (both inclusive) at lumbar spine; Body weight: 50 to 90 kg (both inclusive); At least 3 intact, nonfractured vertebrae in the L1-L4 region are evaluable by DXA (as assessed by central imaging center).
Exclusion: Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab); Prior or ongoing use of any anti-osteoporotic treatment. For the rest of the exclusion criteria, please refer to the study protocol; Known history of hypersensitivity or allergic reactions to denosumab or any of its excipients; T-score of <-4.0 at either region of lumbar spine, total hip, or femoral neck.