Bisphosphonate Treatment of Osteogenesis Imperfecta - Tabular View

Tracking Information
First Received Date ^ICMJE	June 27, 2003
Last Updated Date	September 25, 2007
Start Date ^ICMJE	June 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Change in lumbar spine bone mineral density at month 12 relative to baseline
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00063479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Change in Z score of the lumbar spine at month 12 relative to baseline
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Bisphosphonate Treatment of Osteogenesis Imperfecta
Official Title ^ICMJE	Bisphosphonate Treatment of Osteogenesis Imperfecta
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Osteogenesis Imperfecta
Intervention ^ICMJE	Drug: Zoledronic Acid
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	158
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	3 Months to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063479
Responsible Party
Study ID Numbers ^ICMJE	CZOL446H2202
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP