Study on the Effects of BP16 and Denosumab in Women with Post-Menopausal Osteoporosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called BP16 in women with post-menopausal osteoporosis. Osteoporosis is a condition where bones become weak and are more likely to break. The study will compare BP16 to another medication known as EU-Prolia. The purpose of the study is to see if BP16 is as effective and safe as EU-Prolia in treating this condition.

Participants in the study will receive either BP16 or EU-Prolia through a method called subcutaneous injection, which means the medication is given under the skin. The study will also include a group that receives a placebo. The trial will last for about a year, during which participants will have regular check-ups to monitor their bone health and overall well-being. The study will look at changes in bone mineral density, which is a measure of bone strength, and other markers of bone health.

In addition to BP16 and EU-Prolia, the study will also involve the use of Vitamin D3 and calcium carbonate, which are commonly used to support bone health. Participants will be monitored for any side effects or reactions to the medications. The study aims to provide valuable information on the effectiveness and safety of BP16 for women with post-menopausal osteoporosis, potentially offering a new treatment option for this condition.

1 initial visit and consent

Upon joining the study, the first step involves signing a written informed consent form. This confirms understanding and agreement to follow the study procedures and requirements.

Eligibility is confirmed based on criteria such as age, evidence of osteoporosis, body weight, and the condition of vertebrae in the lumbar spine.

2 baseline assessments

Initial assessments are conducted to establish baseline measurements. These include bone mineral density (BMD) tests and other health evaluations.

3 medication administration

The study involves the administration of BP16 or a comparator, EU-Prolia, through subcutaneous injection. The frequency and dosage are determined by the study protocol.

Additional medications include Vitamin D3 in the form of 400 IU soft capsules and Calcium Carbonate, both taken orally.

4 follow-up visits

Regular follow-up visits are scheduled to monitor progress and collect data. These visits include assessments of bone turnover markers and BMD at specified intervals, such as Week 26, Week 52, and Week 78.

Blood samples may be taken to measure serum concentrations and check for any antibodies against the medication.

5 safety monitoring

Throughout the study, safety is monitored through physical examinations, vital signs, and laboratory tests. Any adverse events or reactions are recorded and assessed.

6 final assessment

At the end of the study period, a final assessment is conducted to evaluate the overall effects of the treatment on bone mineral density and other health parameters.

Who Can Join the Study?

The patient must provide a signed and dated written informed consent before any study-specific procedures. This means they agree to participate and understand what the study involves.
The patient must be a post-menopausal woman, which means she has stopped having menstrual periods, and be between the ages of 55 and 80 years old at the time of the screening visit.
The patient must have evidence of osteoporosis, a condition where bones become weak and brittle. This is assessed by a test called BMD (Bone Mineral Density) at the lumbar spine, with a T-score between -2.5 and -4.0.
The patient’s body weight must be between 50 and 90 kg.
The patient must have at least 3 intact, nonfractured vertebrae in the L1-L4 region of the spine that can be evaluated by a test called DXA (Dual-energy X-ray Absorptiometry), which is done by a central imaging center.

Who Cannot Join the Study?

Patients who are not post-menopausal women cannot participate.
Men are not eligible to join the study.
Individuals who are considered part of a vulnerable population are excluded. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities who might need extra protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD	Sliven	Bulgaria
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Łódź	Lodz	Poland
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Veselibas Centrs 4 SIA	Riga	Latvia
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Synexus Polska Sp. z o.o.	Wroclaw	Poland
Synexus Polska Sp. z o.o.	Poznan	Poland
University Multiprophy Hospital For Active Treatment – Plovdiv AD	Plovdiv	Bulgaria
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Somed Cr Sp. z o.o. sp.k.	Lodz	Poland
Reum.hapi s.r.o.	Nove Mesto Nad Vahom	Slovakia
Siguldas Slimnica	Siguldas Pagasts	Latvia
Medical Centre Pratia Clinic EOOD	Plovdiv	Bulgaria
MediTrials OÜ	Tartu	Estonia
Synexus Polska Sp. z o.o.	Warsaw	Poland
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.	Plovdiv	Bulgaria
SYNEXUS Magyarorszag Kft.	Budapest	Hungary
Obudai Egeszsegugyi Centrum Kft.	Zalaegerszeg	Hungary
Medical Center Hera EOOD	Sofia	Bulgaria
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Mcm Polimedica 2 Sp. z o.o.	Warsaw	Poland
Pratia S.A.	Skorzewo	Poland
Veselibas centru apvieniba AS	Riga	Latvia
Adoria SIA	Riga	Latvia
Lukmed 2 Sp. z o.o.	Siedlce	Poland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Qualiclinic Kft.	Budapest	Hungary
Thermium s.r.o.	Piestany	Slovakia
DRC Kft.	Balatonfured	Hungary
Chiremed s.r.o.	Puchov	Slovakia
Center for Clinical and Basic Research AS	Tallin	Estonia
Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD	Sofia	Bulgaria
Spaggwv Ptpmfk Sru z ogrm	Gdansk	Poland
Pndjlt Sxic	Gdynia	Poland
Ovivmqcc sfpzvr	Lučenec	Slovakia
Mkimpazmn Isascgxmqd Cispgjig Silqnrto Stb z oxwa	Warsaw	Poland
Sujjnpn Pmlsvs Sta z oyzp	Gdynia	Poland
Sjnlemu Pjulkk Sxu z otcm	Czestochowa	Poland
Mvmkumx Cuoqzf Mbiqwtgnwm Posmlf Ofh	Pleven	Bulgaria
Ewyw Thonbpn Cqmefbh Hinfyjem	Tallin	Estonia

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.10.2023
Estonia	Not recruiting	30.10.2023
Hungary	Not yet recruiting	30.10.2023
Latvia	Not recruiting	30.10.2023
Poland	Not recruiting	30.10.2023
Slovakia	Not recruiting	30.10.2023

Trial locations

Investigated drugs:

BP16 is a medication being studied for its effects on bone mineral density (BMD) and bone turnover markers in women with post-menopausal osteoporosis. The trial aims to determine if BP16 is equivalent to another treatment in terms of its ability to improve bone health and reduce bone breakdown.

EU-Prolia is a medication used to treat osteoporosis in post-menopausal women. It works by slowing down the process of bone loss, helping to maintain bone strength and reduce the risk of fractures. The trial is comparing the effects of EU-Prolia with BP16 to see if they provide similar benefits in terms of bone health.

Investigated diseases:

Osteoporosis postmenopausal

Post-Menopausal Osteoporosis – This condition occurs in women after menopause, characterized by a decrease in bone density, making bones more fragile and prone to fractures. The reduction in estrogen levels after menopause accelerates bone loss, leading to a higher risk of fractures, particularly in the spine, hip, and wrist. Over time, the bones become porous and brittle, which can result in fractures even with minor falls or injuries. The progression of the disease is gradual, often without symptoms until a fracture occurs. Regular monitoring of bone mineral density can help in understanding the progression of this condition.

Trial ID:

2023-503790-37-00

Protocol code:

BP16-301

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of BP16 and Denosumab in Women with Post-Menopausal Osteoporosis

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