Alendronate in Juvenile Osteoporosis

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.

Inclusion Criteria:

- Participated in our earlier clinical study;

- Completed the earlier open label or double blind study;

- Availability to participate in the post study;

- Male and female children who have earlier participated in our clinical trial; AND

- Parental consent (and patient assent after age 12 years) to participate in the study.
Participant's consent for those who have completed 18 years of age and above at the
time of clinic visit.

Exclusion Criteria:

- Not participated in our earlier clinical study;

- Not completed our earlier trials; OR

- Pregnancy.