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

PHASE3CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

April 30, 2008

Study Completion Date

March 31, 2010

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

risedronate sodium (Actonel)

risedronate tablet once a day for one year followed by risedronate once a day for two years

DRUG

Placebo

placebo tablet once a day for one year followed by risedronate once a day for two years

Trial Locations (20)

10021

Hospital for Special Surgery, New York

33155

Miami Children's Hospital, Miami

45409

Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital, Dayton

68114

University of Nebraska Medical Center, Children's Hospital, Omaha

97239

Oregon Health & Science University, Portland

Unknown

The Children's Hospital at Westmead, Westmead

Princess Margaret Hospital for Children, Perth

Cliniques Universitaires Saint Luc, Brussels

Pontificia Universidad Catolica de Chile, Santiago

Osteocentrum, II. Interní klinika, Fakultní nemocnice Plzeň-Bory, Pilsen

Hospital for Children and Adolescents, Helsinki

Klinikum und Poliklinik für Kinderheilkunde der Universität zu Köln, Cologne

2nd Department of Pediatrics, Semmelwies University, Faculty of Medicine, Budapest

Rheumatologic Rehabilitation Unit of the University of Verona, Valeggio sul Mincio

"Zaklad Biochemii i Medycyny Doswiadczalnej (Biochemisty Dept, Institute Monument-Children Health Centre", Warzawa-Międzylesie

Little Company of Mary Hospital, Pretoria

Hospital Sant Joan de Deu, Barcelona

Bristol Royal Hospital for Children,, Bristol

G3 8SJ

Royal Hospital for Sick Children, Glasgow

S210 2TH

Sheffield Children's Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Warner Chilcott

INDUSTRY

NCT00106028 - Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children | Biotech Hunter | Biotech Hunter