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.

• Alendronate (Fosamax) (Drug), also known as Fosamax: 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.

Primary outcomes

• Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). [Post study (1-6 yrs), one clinical visit]: Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.

Secondary outcomes

• Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). [Post study (1-6 years), one clincial visit]: Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.
• Number of Participants With Fracture [Post study (1-6 years), one clinical visit]: Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.

Sex: All, ages: 8 Years to 21 Years

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.

Participant flow

Outcome results

• Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). (Primary), Number, participants: 1 Alendronate for 12 Months, Post Study 11
• Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). (Secondary), Number, participants: 1 Alendronate for 12 Months, Post Study 10
• Number of Participants With Fracture (Secondary), Number, participants: 1 Alendronate for 12 Months, Post Study 0

Adverse events

Time frame: 1-6 years post study

• Results publication: Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6. PMID 12795371

• Deborah A Bowlby, M.D., Principal investigator, Medical University of South Carolina

NIH grants: R01FD001847