BridgeMD
Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid
EU CTIS ID: 2024-519705-36-00
What this study is testing
To determine if a two year spell of treatment with a drug called teriparatide (TPTD), followed by treatment with zoledronic acid (ZA) reduces the proportion of participants experiencing a broken bone (fracture) which has been confirmed by x-ray or other imaging. The effects of TPTD/ZA will be compared with standard care which may consist of no active treatment of treatment or treatment with a class of drugs called bisphosphonates depending on the preference of the patient and their normal care provider.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients age 18 years and above with a clinical diagnosis of OI
- Patients willing and able to consent and comply with the study protocol
You likely can't join if
- Current or previous treatment with an investigational (non-licensed) drug with effects on bone metabolism within two years of screening or treatment with teriparatide within two years of screening
- Contraindication to TPTD or ZA
- Women of childbearing potential not using highly effective methods of contraception (see below). Women of childbearing potential (WOCBP) can be enrolled into the study but will be required to use highly effective methods of contraception (as defined by the HMA Clinical Trial Facilitation Group recommendations) before, during the trial if they are being treated with TPTD or bisphosphonates. Examples of highly effective contraception include: • Established use of oral, injected or implanted hormonal methods of contraception. • Placement of an intrauterine device (IUD) or intrauterine system (IUS). • Bilateral tubal occlusion • Vasectomised partner True abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps with or without spermicidal foam/gel/film/cream/suppository) are not considered to be highly effective methods of contraception
- Pregnancy
- Women that are breastfeeding
- Age <18 years
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.