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Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
NCT00106028 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG risedronate sodium (Actonel)
Study Locations (20)
Other
- 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
- Hospital Sant Joan de Deu — Barcelona
- Bristol Royal Hospital for Children, — Bristol
Florida
- Miami Children's Hospital — Miami
Nebraska
- University of Nebraska Medical Center, Children's Hospital — Omaha
New York
- Hospital for Special Surgery — New York
Ohio
- Wright State University BioMedical Imaging Laboratory and Miami Valley Hospital — Dayton
Oregon
- Oregon Health & Science University — Portland
New South Wales
- The Children's Hospital at Westmead — Westmead
Gauteng
- Little Company of Mary Hospital — Pretoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2004-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106028
The ClinicalTrials.gov registry entry for NCT00106028 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00106028 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00106028 about?
NCT00106028 is a clinical study titled "Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children". 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 r...
What is the current status of trial NCT00106028?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2004-11. Estimated completion is 2010-03.
What conditions does trial NCT00106028 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00106028?
The interventions under investigation include: Placebo (DRUG), risedronate sodium (Actonel) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00106028?
This trial is sponsored by Warner Chilcott, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00106028 being conducted?
This trial has 20 study locations across Florida, Nebraska, New York, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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