Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with
juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate
improved BMD of the spine and hip without any major side effects. There were no additional
fractures during therapy. The present study is designed to further evaluate the safety and
efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind,
randomized, placebo-controlled, cross-over protocol.
Phase:
Phase 2
Details
Lead Sponsor:
Medical University of South Carolina
Collaborators:
FDA Office of Orphan Products Development Merck Sharp & Dohme Corp.
Treatments:
Alendronate Calcium, Dietary Ergocalciferols Vitamin D Vitamins