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Matrix-Directed Therapy In Older Adolescents And Adults With Osteogenesis Imperfecta
EU CTIS ID: 2024-515516-50-00
What this study is testing
To establish the effective dose of losartan in patients aged 16 years and above with Osteogenisis Imperfecta, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX)
- Therapeutic exploratory (Phase II)
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
- Age 16 years and above
- Not taking prohibited concomitant medications, listed in exclusion criteria
- Does not have any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator.
- Prior treatment with the oral bisphosphonate risedronate of any duration is permitted provided there has been a 12 month washout period since the last dose of treatment was given
- Prior treatment with more than 6 weeks of oral or more than one single intravenous bisphosphonate therapy is allowed provided there has been a 10-year washout period since the last dose of treatment.
- Subjects not eligible (i.e., safety, tolerability and/or compliance issues, investigator’s judgement, etc.) or do not have access to the authorized products (i.e., neridronate in Italy).
You likely can't join if
- Current use of losartan
- Current medication with other substances which may induce hypotension
- Currently taking oral bisphosphonates or intravenous bisphosphonates
- Prior treatment with more than 6 weeks oral bisphosphonates treatment within 10 years of the consent
- Prior treatment with more than a single dose of intravenous bisphosphonate within 10 years of the consent
- Prior treatment with more than one dose of denosumab within 1 year of the consent
See the full eligibility criteria
- Age 16 years and above
- Not taking prohibited concomitant medications, listed in exclusion criteria
- Does not have any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator.
- Prior treatment with the oral bisphosphonate risedronate of any duration is permitted provided there has been a 12 month washout period since the last dose of treatment was given
- Prior treatment with more than 6 weeks of oral or more than one single intravenous bisphosphonate therapy is allowed provided there has been a 10-year washout period since the last dose of treatment.
- Subjects not eligible (i.e., safety, tolerability and/or compliance issues, investigator’s judgement, etc.) or do not have access to the authorized products (i.e., neridronate in Italy).
- Prior treatment with more than a single dose of denosumab is allowed provided there has been a 1-year washout period since the last dose of treatment.
- Diagnosed with osteogenesis imperfecta (any type)
- Prior treatment with up to and including 6 weeks of oral bisphosphonate therapy is allowed provided there has been a 12 month washout period since the last dose of treatment.
- Prior treatment with a single dose of an intravenous bisphosphonate is allowed provided there has been an 18 month washout period since the treatment was given
- A women of childbearing potential (WOCBP) who agrees to use an effective method of contraception from point of signing the informed consent throughout the study.
- Agreed not to participate in another interventional research project during their involvement in this study.
- Current use of losartan
- Current medication with other substances which may induce hypotension
- Currently taking oral bisphosphonates or intravenous bisphosphonates
- Prior treatment with more than 6 weeks oral bisphosphonates treatment within 10 years of the consent
- Prior treatment with more than a single dose of intravenous bisphosphonate within 10 years of the consent
- Prior treatment with more than one dose of denosumab within 1 year of the consent
- Recent (last 12 months) or current treatment likely to affect bone – this does not include inhaled or intermittent oral therapy with steroids for asthma (no more than three months of oral steroids in previous 12 months)
- Severe Hepatic impairment (AST ≥ 144U/L, ALT ≥ 165U/L, GGT ≥ 183 U/L)
- Renal impairment (GFR <60ml/min/m2; GFR in children will be assessed using the Bedside Schwartz equation) if treated with aliskiren-containing products.
- Diabetes mellitus if treated with aliskiren-containing products
- Cardiac failure if treated with diuretics (excluding grade 1 according to the NYHA Functional Classification)
- Known hypersensitivity to losartan or any of the excipients
- Pregnancy or lactation
- Prior treatment with more than 6 weeks oral bisphosphonates, except risedronate, within 10 years of consent
- Prior treatment with risedronate within 12 months of consent
- Drinking grapefruit juice throughout the study duration
- Prior use of losartan within preceding 6 month to enrolment
- Recent fracture in the prior 6 months to enrolment
- Presence of other chronic illnesses including renal failure likely to affect bone metabolism or structure. GFR in children will be assessed using the Bedside Schwartz equation
- Known severe hypotension resulting in dizziness, fainting or headaches
- Hyperkalaemia
- Current medication that increases potassium retention, or may increase potassium levels, such as potassium-retaining diuretics
- Current medication with lithium
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, 0-17 years, 18-64 years, 65+ 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.