Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
NCT ID: NCT00106028
Last Updated: 2013-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2004-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo Daily
placebo tablet, once a day for one year then for two years open label risedronate
Placebo
placebo tablet once a day for one year followed by risedronate once a day for two years
Risedronate Daily
risedronate tablet, once a day for one year then for two years open label risedronate once a day
risedronate sodium (Actonel)
risedronate tablet once a day for one year followed by risedronate once a day for two years
Interventions
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risedronate sodium (Actonel)
risedronate tablet once a day for one year followed by risedronate once a day for two years
Placebo
placebo tablet once a day for one year followed by risedronate once a day for two years
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
4 Years
15 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Dietrich H Wenderoth, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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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
Countries
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References
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Bishop N, Adami S, Ahmed SF, Anton J, Arundel P, Burren CP, Devogelaer JP, Hangartner T, Hosszu E, Lane JM, Lorenc R, Makitie O, Munns CF, Paredes A, Pavlov H, Plotkin H, Raggio CL, Reyes ML, Schoenau E, Semler O, Sillence DO, Steiner RD. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Oct 26;382(9902):1424-32. doi: 10.1016/S0140-6736(13)61091-0. Epub 2013 Aug 6.
Other Identifiers
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HMR4003I/3001
Identifier Type: -
Identifier Source: secondary_id
2003100
Identifier Type: -
Identifier Source: org_study_id
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