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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 |
| 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:
Creatinine clearance = [(height in cm x 0.55)/plasma creatinine] for all females and for males < 13 years old; [(height in cm x 0.70)/plasma creatinine] for males ³ 13 years old.
Contacts and Locations
More Information
| Study ID Numbers: | 04-12-187R |
| Study First Received: | July 7, 2005 |
| Last Updated: | January 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00277251 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Crohn’s disease systemic-onset juvenile rheumatoid arthritis juvenile dermatomyositis |
systemic lupus erythematosus (SLE) Mixed connective tissue disease (MCTD) vasculitis |
|
Crohn's Disease Arthritis, Juvenile Rheumatoid Vasculitis Ileitis Lupus Enteritis Arthritis, Rheumatoid Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Juvenile Dermatomyositis |
Glucocorticoids Bone Diseases Dermatomyositis Sharp Syndrome Musculoskeletal Diseases Lupus Erythematosus, Systemic Alendronate Mixed Connective Tissue Disease Arthritis Crohn Disease Connective Tissue Diseases |
|
Musculoskeletal Diseases Alendronate Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |