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| Sponsored by: |
Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00159419 |
Purpose
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone |
Drug: Alendronate Drug: Pamidronate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Bisphosphonate Therapy for Osteogenesis Imperfecta |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 1999 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen, OR by bone mineral density (BMD) <2.5 standard deviations (SD) for age plus two of the following:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| IU School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: LeeAnn Ford, RN, CCRC 317-274-0668 lford@iupui.edu | |
| Contact: Linda A DiMeglio, MD 317/274-3889 dimeglio@iupui.edu | |
| Principal Investigator: Linda A DiMeglio, MD, MPH | |
| Principal Investigator: | Linda A DiMeglio, MD, MPH | Indiana University School of Medicine |
More Information
| Responsible Party: | Indiana University School of Medicine ( Linda DiMeglio, MD ) |
| Study ID Numbers: | NIH/NCRR |
| Study First Received: | September 7, 2005 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00159419 |
| Health Authority: | United States: Institutional Review Board |
|
Osteogenesis Imperfecta Fractures Pediatric Osteoporosis Juvenile Pagets |
|
Osteogenesis Imperfecta Osteogenesis imperfecta Collagen Diseases Fractures, Bone Osteochondrodysplasias Osteoporosis Bone Diseases, Metabolic Bone Diseases Pagets disease |
Diphosphonates Musculoskeletal Diseases Genetic Diseases, Inborn Alendronate Osteitis Deformans Bone Diseases, Developmental Connective Tissue Diseases Pamidronate Osteitis |
|
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |
