drugset / Trial / NCT00277251
Alendronate Osteoporosis Study
Phase 2/3
Completed
20 enrolled
Boston Children's Hospital
Elizabeth Glaser Pediatric AIDS Foundation · collabGlaser Pediatric Research Network · collab
RandomizedFactorialDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2003-03
- Primary completion
- 2006-06
- Completion
- 2006-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | — | — |