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| Sponsors and Collaborators: |
Children's Hospital Boston Glaser Pediatric Research Network Elizabeth Glaser Pediatric AIDS Foundation |
| Information provided by: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00277251 |
Purpose
This trial will test the hypothesis that among 20 children and adolescents from Children's Hospital, Boston with Crohn’s disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of standard of care therapy.
| Condition | Intervention | Phase |
|
Glucocorticoid-Associated Osteopenia and Osteoporosis |
Drug: Alendronate |
Phase II Phase III |
| MedlinePlus related topics: | Connective Tissue Disorders Crohn's Disease Juvenile Rheumatoid Arthritis Lupus Osteoporosis Rheumatoid Arthritis Vasculitis |
| ChemIDplus related topics: | Alendronate Alendronate sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2003 |
Eligibility
| Ages Eligible for Study: | 8 Years to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 04-12-187R |
| First Received: | July 7, 2005 |
| Last Updated: | January 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00277251 |
| Health Authority: | United States: Food and Drug Administration |
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