The investigators earlier have shown that treatment of patients with juvenile osteoporosis
with alendronate (Fosamax) for 12 months increased the bone density without side effects. In
an open label study (10 patients) and double blind, crossover study (11 patients alendronate
and 11 patients placebo), the investigators have further observed that alendronate increased
the bone density significantly where as placebo (calcium and vitamin D) increased only
minimally. These trials were completed. Thus, a post study is designed to evaluate the
current status of the bone density and fractures after the patients discontinued the
alendronate treatment. No treatment is involved.
Details
Lead Sponsor:
Medical University of South Carolina
Collaborators:
FDA Office of Orphan Products Development Merck Sharp & Dohme Corp.