Bisphosphonate Treatment of Osteogenesis Imperfecta
- Conditions
- Osteogenesis ImperfectaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003539-37-Outside-EU/EEA
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 158
Inclusion Criteria
Inclusion
•Male or Female children between 3 months and 17 years old
•OI type I, III or IV
Are the trial subjects under 18? yes
Number of subjects for this age range: 158
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Change in Z score of the lumbar spine at month 12 relative to baseline<br>;Primary end point(s): Primary Outcome Measures: •Change in lumbar spine bone mineral density at month 12 relative to baseline<br><br>;Timepoint(s) of evaluation of this end point: Change in lumbar spine bone mineral density at month 12 relative to baseline<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Outcome Measures: •Change in Z score of the lumbar spine at month 12 relative to baseline<br>;Timepoint(s) of evaluation of this end point: Change in Z score of the lumbar spine at month 12 relative to baseline<br>