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

Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteogenesis Imperfecta

Intervention: risedronate sodium (Actonel) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Warner Chilcott

Official(s) and/or principal investigator(s):
Dietrich H Wenderoth, MD, Study Director, Affiliation: Procter and Gamble

Summary

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.

Clinical Details

Official title: Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population

Secondary outcome:

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population

Percent Change From Baseline in Total Body BMD at Month 12, ITT Population

Percent Change From Baseline in Total Body BMD at Month 24, ITT Population

Percent Change From Baseline in Total Body BMD at Month 36, ITT Population

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population

Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population

Percent Change From Baseline in Total Body BMC at Month 12, ITT Population

Percent Change From Baseline in Total Body BMC at Month 24, ITT Population

Percent Change From Baseline in Total Body BMC at Month 36, ITT Population

Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population

Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population

Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population

Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population

Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population

Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population

Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population

Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population

Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population

Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population

Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population

Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population

New Morphometric Vertebral Fracture at Month 12, ITT Population

New Morphometric Vertebral Fracture at Month 36, ITT Population

Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT

Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT

Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population

Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population

Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population

Number of Clinical Fractures, Month 12, ITT Population

Serum BAP - Percent Change From Baseline to Month 12, ITT Population

Serum BAP - Percent Change From Baseline to Month 24, ITT Population

Serum BAP - Percent Change From Baseline to Month 36, ITT Population

Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population

Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population

Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population

Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population

Bone Age (Years), Change From Baseline to Month 12, ITT Population

Bone Age (Years), Change From Baseline to Month 24, ITT Population

Bone Age (Years), Change From Baseline to Month 36, ITT Population

Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population

Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population

Eligibility

Minimum age: 4 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- Any bisphosphonate use within one year of enrollment

Locations and Contacts

Princess Margaret Hospital for Children, Perth, Australia

Cliniques Universitaires Saint Luc, Bruxelles, Belgium

Pontificia Universidad Catolica de Chile, Santiago, Chile

Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory, Plzen, Czech Republic

Hospital for Children and Adolescents, Helsinki, Finland

Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln, Koln, 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

Hospital Sant Joan de Deu, Barcelona, Spain

Bristol Royal Hospital for Children,, Bristol, United Kingdom

Royal Hospital for Sick Children, Glasgow G3 8SJ, United Kingdom

Sheffield Children's Hospital, Sheffield S210 2TH, United Kingdom

Miami Children's Hospital, Miami, Florida 33155, United States

Little Company of Mary Hospital, Pretoria, Gauteng, South Africa

University of Nebraska Medical Center, Children's Hospital, Omaha, Nebraska 68114, United States

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Hospital for Special Surgery, New York, New York 10021, United States

Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital, Dayton, Ohio 45409, United States

Oregon Health & Science University, Portland, Oregon 97239, United States

Additional Information

Starting date: November 2004
Last updated: April 15, 2013

Page last updated: August 20, 2015

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