Not recruitingRare disease

Study on Treating Osteogenesis Imperfecta in Patients Using Teriparatide and Zoledronic Acid

Verified siteRegistered drugNo placebo

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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 certain treatments on a condition known as osteogenesis imperfecta, which is a genetic disorder characterized by fragile bones that break easily. The study will explore the use of a medication called teriparatide, followed by zoledronic acid, to see if this combination can reduce the number of bone fractures in participants. The effects of these medications will be compared to standard care, which may include no active treatment or the use of drugs known as bisphosphonates, depending on what the patient and their healthcare provider decide is best.

Participants in the study will first receive teriparatide for two years. This medication is given as an injection and is sometimes used to help strengthen bones. After this period, participants will receive zoledronic acid, which is administered as an infusion, to further support bone health. The study aims to determine if this treatment plan can effectively reduce the occurrence of fractures, which will be confirmed through imaging techniques like x-rays.

The study will also monitor other aspects such as the total number of fractures, bone pain, quality of life, and functional status over time. These will be assessed using various questionnaires and tools to ensure a comprehensive understanding of the treatment's impact. The study is expected to last for several years, with regular follow-ups to track the participants' progress and gather necessary data.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent, confirming your willingness to participate and comply with the study protocol.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of osteogenesis imperfecta and ensuring you meet the age requirement of 18 years or older.
Step 3
Treatment phase 1
You will begin treatment with a drug called teriparatide (TPTD). This medication is administered as a solution for injection using a pre-filled pen. The dosage is 20 micrograms per injection, and it is typically administered daily for a duration of two years.
Step 4
Treatment phase 2
After completing the two-year course of teriparatide, you will transition to treatment with zoledronic acid (ZA). This medication is given as a solution for infusion. The dosage is 5 mg per 100 ml of solution, administered once a year.
Step 5
Monitoring and follow-up
Throughout the study, your health will be monitored regularly. This includes checking for any fractures using x-rays or other imaging techniques. Your bone pain, quality of life, and functional status will be assessed at 12 months, 24 months, and at the end of the study, which is expected to last approximately 62 months.
Step 6
Completion of study
The study will conclude once 139 participants have experienced a clinical fracture confirmed by imaging. This is anticipated to occur after an average follow-up period of 62 months.

Who can join the trial?

2 criteria

Adults aged 18 years and older with a clinical diagnosis of Osteogenesis Imperfecta (OI). OI is a condition that affects the bones, making them fragile and more likely to break.
Patients who are willing and able to give their consent to participate in the study and follow the study guidelines.

Who cannot join the trial?

8 criteria

Participants who do not have a confirmed diagnosis of osteogenesis imperfecta. This is a condition where bones break easily, often with little or no apparent cause.
Participants who are not within the specified age range for the study.
Participants who are not willing to follow the study procedures or take the study medications.
Participants who have other medical conditions that might interfere with the study or make participation unsafe.
Participants who are currently taking medications that could interfere with the study drugs.
Participants who are pregnant or planning to become pregnant during the study period.
Participants who have a history of allergic reactions to the study drugs or similar medications.
Participants who have participated in another clinical trial recently and are still within the exclusion period.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aarhus University Hospital
Verified
Aarhus, Denmark
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Assistance Publique Hopitaux De Paris
Verified
Paris, France

Trial locations

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Investigated drugs

Teriparatide
is a medication used in this clinical trial to help strengthen bones. It is a form of parathyroid hormone, which is naturally found in the body and plays a key role in bone health. In this study, teriparatide is given to participants to see if it can reduce the risk of fractures in people with a condition called Osteogenesis Imperfecta, which makes bones fragile and more likely to break.
Zoledronic Acid
is another medication used in this trial. It belongs to a group of drugs known as bisphosphonates, which help to prevent bone loss. In this study, after participants have been treated with teriparatide, they receive zoledronic acid to see if it can further reduce the chances of fractures. This medication works by slowing down the process that breaks down bone tissue, helping to maintain bone strength.

What is already known about the treatment

Teriparatide
Teriparatide is administered via subcutaneous injection and is currently being studied for its effectiveness in treating osteogenesis imperfecta. It is a synthetic form of parathyroid hormone and is used to stimulate bone growth. The medication works by activating osteoblasts, which are cells that build bone, thereby increasing bone density. Teriparatide is classified as an anabolic (bone-building) agent.
Zoledronic Acid
Zoledronic acid is given through intravenous infusion and is also being evaluated for its role in managing osteogenesis imperfecta. It is a type of bisphosphonate, which helps to prevent bone breakdown by inhibiting osteoclasts, the cells responsible for bone resorption. This medication is used to strengthen bones and reduce the risk of fractures. Zoledronic acid is classified as an antiresorptive agent.

Investigated diseases

Osteogenesis imperfecta – Osteogenesis imperfecta is a genetic disorder characterized by fragile bones that break easily, often with little or no apparent cause. It is caused by a defect in the production of collagen, a protein that is crucial for bone strength. The condition can vary in severity, with some individuals experiencing frequent fractures, while others may have only a few throughout their lifetime. In addition to bone fragility, people with osteogenesis imperfecta may have other symptoms such as blue sclerae, hearing loss, and dental issues. The progression of the disease can lead to bone deformities and reduced mobility over time. The severity and specific symptoms can differ widely among individuals with the condition.