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

NCT00106028 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2013-04-22

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Dietrich H Wenderoth, MD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-04-30
Completion
2010-03-31

Countries

  • United States
  • Australia
  • Belgium
  • Chile
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00106028 on ClinicalTrials.gov