Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid
This ongoing study, called a Phase IV trial, is investigating various treatments for adults living with Osteogenesis Imperfecta, often called brittle bone disease. The main goal is to find out how many people experience bone breaks (fractures) and how different medications might help reduce these. Researchers are tracking participants over an average of five years to see the real-world effects of existing treatments like Alendronic Acid, Zoledronic Acid, and others. They will record all bone breaks confirmed by X-rays or other scans until 139 participants have had a fracture. The study also looks at how these treatments affect bone pain, quality of life, and daily activities, while also monitoring for any side effects.
At a glance
What is this study about?
This study is focused on a condition called Osteogenesis Imperfecta (OI), which makes bones very fragile and likely to break easily. This is often known as brittle bone disease. The study is a 'Phase IV' trial, which means it's looking at medicines that are already approved and being used to treat people. Researchers want to understand how well these different treatments work in the real world for adults with OI.
The main aim is to see how many people experience a bone fracture (break) while on these treatments. They'll be carefully checking all types of breaks, especially those confirmed by X-rays or other scans. The study will continue until 139 people have had a fracture, which they expect will take about five years for each person enrolled. This way, they can compare the effectiveness of various medications on preventing breaks.
Beyond just counting fractures, the study will also look at other important aspects of living with OI. This includes gathering information on how much bone pain people experience, how their quality of life is affected, and how well they can carry out daily activities. They will also look for any side effects of the medications. By collecting all this information, doctors can gain a better understanding of which treatments might be most helpful for people with Osteogenesis Imperfecta.
Key takeaways
- This study is for adults with Osteogenesis Imperfecta (brittle bone disease).
- It aims to understand how well existing treatments reduce bone breaks.
- Participants will be followed for about five years on average.
- The study also checks pain, quality of life, and daily activities.
- It's a 'real-world' study of approved medications.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit for taking part, meaning people of all adult ages can potentially join.
Both men and women are welcome to participate. The study is designed to include a wide range of people with Osteogenesis Imperfecta to get a good picture of how the treatments work across different individuals.
The clinical trial team will have specific medical criteria that you'll need to meet to ensure the study is safe and suitable for you. These will likely focus on your diagnosis of Osteogenesis Imperfecta and your general health. It's best to discuss your individual situation with your doctor.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Osteogenesis Imperfecta?
- Are you able to attend regular check-ups and assessments?
- Are you currently receiving or considering treatment for OI?
What does participation involve?
If you join this study, you would be receiving one of the existing treatments for Osteogenesis Imperfecta that your doctor would normally prescribe. This is not a study testing new, unapproved medicines. The main things involved would be regular check-ups where doctors will carefully monitor your health and any bone fractures you experience, confirmed by X-rays or other imaging. You would also be asked to complete questionnaires to assess your bone pain, how your condition affects your daily life (quality of life), and your ability to do different activities. These assessments would happen at the start, then after 12 months, 24 months, and finally at the end of the study, which is expected to be around 62 months (just over five years) on average after you begin.
Potential risks and benefits
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Common questions
What is Osteogenesis Imperfecta?
Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a genetic condition that makes your bones easily breakable, even from minor bumps or falls.
Is this study testing a new medicine?
No, this study is looking at existing, approved medicines already used to treat OI. It's trying to gather more information on how well they work in real-world situations.
How long will I be in the study?
On average, participants are expected to be followed for about 62 months, which is just over five years. The study will continue until enough bone fractures have been observed across all participants.
What happens if I break a bone during the study?
Any bone breaks (fractures) you experience will be carefully recorded and confirmed with X-rays or other scans, as this is a key part of what the researchers are studying.
Will I have to take different medicines than my doctor prescribes?
No, this study observes the effects of standard treatments that your doctor would normally recommend or prescribe for your Osteogenesis Imperfecta.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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