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Sponsors and Collaborators: |
Glaser Pediatric Research Network Elizabeth Glaser Pediatric AIDS Foundation |
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Information provided by: | Glaser Pediatric Research Network |
ClinicalTrials.gov Identifier: | NCT00209469 |
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.
Condition | Intervention | Phase |
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Osteopenia Osteoporosis |
Drug: alendronate sodium |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis |
Estimated Enrollment: | 90 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | February 2007 |
This trial will test the hypothesis that among 90 children and adolescents 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.
Ages Eligible for Study: | 8 Years to 22 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
Stanford University | |
Stanford, California, United States, 94305 | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 | |
United States, Massachusetts | |
Children's Hospital, Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Emily von Scheven, MD | University of California, San Francisco |
Study ID Numbers: | GPRN1.OSTEO.PL.6.0 |
Study First Received: | September 12, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00209469 |
Health Authority: | United States: Food and Drug Administration |
Musculoskeletal Diseases Alendronate Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |