Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteogenesis Imperfecta

In brief

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Key facts

Study ID

NCT00106028

Run by

Warner Chilcott

People needed

143

Starts

2004-11-01

Expected to finish

2010-03-01

Last updated by the study team

2013-04-22

Who can join

Age: 4 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• OI diagnosis
• increased risk of fracture: either has a history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or has very low BMD with or without a history of fractures.

You may not qualify if…

• Any bisphosphonate use within one year of enrollment

Where it is running

• Miami Children's Hospital — Miami, Florida, United States
• University of Nebraska Medical Center, Children's Hospital — Omaha, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital — Dayton, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Princess Margaret Hospital for Children — Perth, Australia
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• Pontificia Universidad Catolica de Chile — Santiago, Chile
• Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory — Pilsen, Czechia
• Hospital for Children and Adolescents — Helsinki, Finland
• Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln — Cologne, Germany
• 2nd Department of Pediatrics, Semmelwies University, Faculty of Medicine — Budapest, Hungary
• Rheumatologic Rehabilitation Unit of the University of Verona — Valeggio sul Mincio, Italy
• Zaklad Biochemii i Medycyny Doswiadczalnej (Biochemisty Dept, Institute "Monument-Children Health Centre" — Warzawa-Międzylesie, Poland
• Little Company of Mary Hospital — Pretoria, Gauteng, South Africa
• Hospital Sant Joan de Deu — Barcelona, Spain
• Royal Hospital for Sick Children — Glasgow, Glasgow, United Kingdom
• Sheffield Children's Hospital — Sheffield, Sheffield, United Kingdom
• Bristol Royal Hospital for Children, — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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