Bisphosphonate Therapy for Osteogenesis Imperfecta
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|ClinicalTrials.gov Identifier: NCT00159419|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : March 31, 2016
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone||Drug: Alendronate Drug: Pamidronate||Phase 4|
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). In its most severe form, the disorder is lethal in infancy. We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI.
Additionally, we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bisphosphonate Therapy for Osteogenesis Imperfecta|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Active Comparator: Alendronate
1 mg/kg po qd rounded to nearest 10 or 20 mg dose
Other Name: fosamax
Active Comparator: Pamidronate
3 mg/kg IV q4 months
- Bone Mineral Density [ Time Frame: 2 years ]By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome", or similar, as accurate and appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159419
|Principal Investigator:||Linda A DiMeglio, MD, MPH||Indiana University School of Medicine|