CompletedPhase 2

Bisphosphonate Treatment of Osteogenesis Imperfecta

United States158 participantsStarted 2003-06

Plain-language summary

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Who can participate

Age range3 Months – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion * Male or Female children between 3 months and 17 years old * OI type I, III or IV Exclusion * Deformity or abnormality which would prevent spine bone density from being done * Any surgical bone-lengthening procedure * Any kidney diseases or abnormalities * Low calcium or vitamin D levels in the blood Other protocol-defined inclusion/exclusion criteria may apply.

What they're measuring

Change in lumbar spine bone mineral density at month 12 relative to baseline

Trial details

NCT IDNCT00063479

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-05

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