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NCT00106028COMPLETEDanonymous

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

Sponsor

Source record

Warner Chilcott

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

risedronate sodium (Actonel), Placebo

Indication / condition

AI-normalized

Osteogenesis Imperfecta

Intervention

Source record

risedronate sodium (Actonel), Placebo

Source & freshness

Source record

NCT ID

NCT00106028

Original source

ClinicalTrials.gov

Source last updated

Apr 22, 2013

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT00106028

Title

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

Sponsor

Warner Chilcott

Status

COMPLETED

Phase

PHASE3

Condition raw

Osteogenesis Imperfecta

Condition normalized

Osteogenesis Imperfecta

Modality raw

small molecule

Modality normalized

small molecule

Target raw

risedronate sodium (Actonel), Placebo

Target normalized

risedronate sodium (Actonel), Placebo

Interventions

risedronate sodium (Actonel), Placebo

Public preview

Source record

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.

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