osartan for older adolescents and adults with osteogenesis imperfecta

Phase 2

• Conditions: Osteogenesis imperfecta; Musculoskeletal Diseases

• Registration Number: ISRCTN13317811
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-17
• Last Update Posted: 20 November 2023
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified