Matrix-directed therapy in older adolescents and adults with osteogenesis imperfecta – the MOI-A study

Sheffield Children's NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2023年8月17日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1. Age 16 years and above
•2. Diagnosed with osteogenesis imperfecta (any type)
•3. Prior treatment with up to and including 6 weeks of oral bisphosphonate therapy is allowed provided there has been a 6-month washout period since the last dose of treatment
•4. Prior treatment with a single dose of an intravenous bisphosphonate is allowed provided there has been a 6-month washout period since the treatment was given
•5. Prior treatment with a single dose of denosumab is allowed provided there has been a 6-month washout period since the treatment was given
•6. A woman of childbearing potential (WOCBP) who agrees to use an effective method of contraception from point of signing the informed consent throughout the study
•7. Agreed not to participate in another interventional research project during their involvement in this study
•8. Not taking prohibited concomitant medications, listed in exclusion criteria
•9. Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator

•1. Current use of losartan
•2. Prior use of losartan within the preceding 6 months to enrolment
•3. Presence of other chronic illnesses including renal failure likely to affect bone metabolism or structure
•4. Known severe hypotension resulting in dizziness, fainting or headaches
•5. Hyperkalaemia
•6. Current medication that increases potassium retention, or may increase potassium levels, such as potassium-retaining diuretics
•7. Current medication with lithium
•8. Current medication with other substances which may induce hypotension
•9. Currently taking oral bisphosphonates or intravenous bisphosphonates
•10. Prior treatment with more than 6 weeks oral bisphosphonates treatment
•11. Prior treatment with more than a single dose of intravenous bisphosphonate
•12. Prior treatment with more than one dose of denosumab
•13. 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 3 months of oral steroids in previous 12 months)
•14. Severe hepatic impairment
•15. Renal impairment (glomerular filtration rate [GFR] <60 ml/min/m²) if treated with aliskiren-containing products
•16. Diabetes mellitus if treated with aliskiren-containing products
•17. Cardiac failure treated with diuretics
•18. Pregnancy or lactation
•19. Known hypersensitivity to losartan or any of the excipients

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