BridgeMD
Efficacy, safety, PK, PD, and immunogenicity of BP16 in post-menopausal osteoporosis
EU CTIS ID: 2023-503790-37-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Known history of hypersensitivity or allergic reactions to denosumab or any of its excipients.
- Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab).
- T-score of <-4.0 at either region of lumbar spine, total hip, or femoral neck.
- Prior or ongoing use of any anti-osteoporotic treatment. For the rest of the exclusion criteria, please refer to the study protocol.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.