Alendronate in Juvenile Osteoporosis
Condition: Juvenile Osteoporosis; Low Bone Density; Fractures
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has
      been recognized and diagnosed in recent years. The disease results from either diminished
      bone formation or increased bone removal (resorption) resulting in low bone density and
      fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an
      open label study, we earlier have shown that alendronate treatment (10 patients) for 12
      months increased bone density without side effects. Subsequently, in a double blind,
      crossover study, we have further confirmed that alendronate treatment (11 patients) increased
      bone density significantly whereas, placebo (11 patients with calcium and vitamin D),
      increased the bone density only minimally. There were no side effects. These patients were
      treated with alendronate only for 12 months and the clinical trials have been completed. We
      therefore, have designed a post study to evaluate the current status of the bone density and
      fracture history in the above participants after the discontinuation (1-6 years) of
      alendronate treatment. Available participants, who have completed the earlier study, will be
      scheduled for a one time clinic visit. Measurements include DXA bone density measurement of
      spine and hip, urinalysis and blood work. No treatment is involved.
    

Intervention name(s): Alendronate (Fosamax)
Intervention type(s): Drug
Intervention description(s): Pill, 35mg or 70mg depending upon the body weight for 12 months. This was given for participants during the open label or double blind study. Current study is a post study evaluation of the current status of bone density after the participants completed the study. In this post study, no treatment is involved.
Other intervention name(s): Fosamax
Intervention MeSH terms: Alendronate
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Available male and female children who have participated and Completed in our earlier open
        label or double blind clinical trial.
      
Keywords: Juvenile Osteoporosis; Bone Mineral Density; Fosamax; Dual Energy X-Ray Absorptiometry; Fracture