2023-503790-37-00CompletedPhase 3
Efficacy, safety, PK, PD, and immunogenicity of BP16 in post-menopausal osteoporosis
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 615 (actual)
- First submitted
- 10 Jul 2023
- Start date
- 9 Jan 2024
- Lead sponsor
- Curateq Biologics Private Limited
- Diseases
- Osteoporosis
- EU CT number
- 2023-503790-37-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 615
- 44 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known history of hypersensitivity or allergic reactions to denosumab or any of its excipients.
Other
- T-score of <-4.0 at either region of lumbar spine, total hip, or femoral neck.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Medconsult Pleven OOD | Pleven | Bulgaria | Completed |
| Medical Centre Leo Clinic EOOD | Plovdiv | Bulgaria | Completed |
| Medical center "Artmed" LTD | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. | Plovdiv | Bulgaria | Completed |
| University Multiprophy Hospital For Active Treatment - Plovdiv AD | Plovdiv | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD | Sliven | Bulgaria | Completed |
| Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD | Sofia | Bulgaria | Completed |
| Medical Center Hera EOOD | Sofiya | Bulgaria | Completed |
| Center for Clinical and Basic Research AS | Tallinn | Estonia | Completed |
| East Tallinn Central Hospital | Tallinn | Estonia | Completed |
| MediTrials OÜ | Tartu Linn | Estonia | Completed |
| Kliiniliste Uuringute Keskus OÜ | Tartu Linn | Estonia | Completed |
| DRC Kft. | Balatonfüred | Hungary | Withdrawn |
| Qualiclinic Kft. | Budapest | Hungary | Withdrawn |
| SYNEXUS Magyarorszag Kft. | Budapest III | Hungary | Withdrawn |
| Obudai Egeszsegugyi Centrum Kft | Zalaegerszeg | Hungary | Withdrawn |
| Adoria SIA | Riga | Latvia | Completed |
| Veselibas Centrs 4 SIA | Riga | Latvia | Completed |
| Veselibas centru apvieniba AS | Riga | Latvia | Completed |
| Siguldas Slimnica | Siguldas Pagasts | Latvia | Completed |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik | Bialystok | Poland | Completed |
| Clinicmed Daniluk Nowak Sp. k. | Bialystok | Poland | Completed |
| Krakowskie Centrum Medyczne Sp. z o.o. | Cracow | Poland | Completed |
| Synexus Polska Sp. z o.o. | Czestochowa | Poland | Completed |
| Synexus Polska Sp z o.o. | Gdansk | Poland | Completed |
| Pratia S.A. | Gdynia | Poland | Completed |
| Synexus Polska Sp. z o.o. | Gdynia | Poland | Completed |
| Pratia S.A. | Katowice | Poland | Completed |
| Futuremeds Sp. z o.o. | Lodz | Poland | Completed |
| Somed Cr Sp. z o.o. sp.k. | Lodz | Poland | Completed |
| Synexus Polska Sp z o o | Poznan | Poland | Completed |
| Lukmed 2 Sp. z o.o. | Siedlce | Poland | Completed |
| Clinmedica Research sp. z o.o. | Skierniewice | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. | Torun | Poland | Completed |
| Futuremeds Sp. z o.o. | Warsaw | Poland | Completed |
| Klinika Reuma Park Sp. z o.o. S.K. | Warsaw | Poland | Completed |
| Synexus Polska Sp. z o.o. | Warsaw | Poland | Completed |
| Singua Sp. z o.o. | Warsaw | Poland | Completed |
| Futuremeds Sp. z o.o. | Wroclaw | Poland | Completed |
| Synexus Polska Sp. z o.o. | Wroclaw | Poland | Completed |
| OSTEOMED s.r.o. | Lučenec | Slovakia | Completed |
| Reum.hapi s.r.o. | Nove Mesto Nad Vahom | Slovakia | Completed |
| Thermium s.r.o. | Piestany | Slovakia | Completed |
| Chiremed, s.r.o. | Púchov | Slovakia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.