Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteogenesis Imperfecta
Intervention: risedronate sodium (Actonel) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Procter and Gamble 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 (two groups will receive risedronate, and one group will receive placebo). 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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objective of the study is to determine the efficacy of risedronate compared to placebo in children 4 to <16 years of age with osteogenesis imperfecta as assessed by percent change from Baseline in lumbar spine bone mineral density at Month 12
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
Royal Hospital for Sick Children, Glasgow G3 8SJ, United Kingdom
Sheffield Children's Hospital, Sheffield S210 2TH, United Kingdom
University of Nebraska Medical Center, Children's Hospital, Omaha, Nebraska 68114, United States
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: August 2004
Ending date: March 2010
Last updated: February 13, 2008
|
