NCT00209469

Network Osteoporosis Study

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: Glaser Pediatric Research Network · Network
• Sex: All
• Age: 8 Years – 22 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	alendronate sodium

Timeline

• Start date: 2002-07-01
• Completion: 2007-02-01
• First posted: 2005-09-21
• Last updated: 2005-09-21

Locations

4 sites across 1 country: United States