Network Osteoporosis Study
Recruitment status was Active, not recruiting
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis|
- Mean change of individual AP spine BMD (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) at 6, 12,18, 24 and 30 Months.
|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.
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Children's Hospital, Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Emily von Scheven, MD||University of California, San Francisco|