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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 2

    Baseline assessments

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

  3. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

  • BP16

    BP16 is administered as an injection, typically given under the skin. It is currently being studied in clinical trials to assess its effectiveness and safety compared to an existing medication, EU-Prolia, for treating post-menopausal osteoporosis. The main therapeutic use of BP16 is to strengthen bones and reduce the risk of fractures in women who have gone through menopause. It works by inhibiting a protein involved in bone breakdown, thereby helping to maintain bone density. BP16 is classified as a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

  • EU-Prolia

    EU-Prolia is administered via subcutaneous injection, meaning it is injected under the skin. It is an established medication used in the treatment of post-menopausal osteoporosis, with a well-documented presence in medical literature. The primary therapeutic indication for EU-Prolia is to increase bone strength and decrease the likelihood of fractures in post-menopausal women. It functions by targeting and inhibiting a protein that causes bone loss, thus helping to preserve bone density. EU-Prolia is also classified as a monoclonal antibody, specifically designed to interact with certain proteins in the body to achieve its effects.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503790-37-00Protocol codeBP16-301Estimated enrolment615 patientsSponsorCurateq Biologics Private Limited

sourced from the EU Clinical Trials Register and site verification

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