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NCT00106028 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Osteogenesis Imperfecta, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
143
Enrollment target
20
Study locations

NCT00106028 is a Phase 3 study of Osteogenesis Imperfecta that has completed, run by Warner Chilcott. The registered enrollment target is 143 participants, roughly in line with the 150-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target. The trial reports 20 study locations across 10 states.

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The verdict

NCT00106028, a Phase 3 study of Osteogenesis Imperfecta, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
143 participants
Enrollment target
20
Study locations

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

Osteogenesis Imperfecta

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

FieldValue
Enrollment Target 143 participants
Start Date 2004-11
Est. Completion 2010-03
Phase Phase 3

Sponsor

Warner Chilcott

53 total trials

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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, categorized as Phase 3. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 150-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.

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.

NCT00106028 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Florida, Nebraska.

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.

What interventions are being tested in trial NCT00106028?

The interventions under investigation include: Placebo (DRUG), risedronate sodium (Actonel) (DRUG).

Who is sponsoring clinical trial NCT00106028?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.