Network Osteoporosis Study

Osteoporosis Clinical Trial

Official title: Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis

Status Active, not recruiting

Clinical Trial Summary

This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

• NCT number: NCT00209469
• Study type: Interventional
• Source: Glaser Pediatric Research Network
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2002
• Completion date: February 2007