Alendronate in Juvenile Osteoporosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study.

Conditions
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Juvenile Osteoporosis, Low Bone Density, Fractures

Intervention / Treatment
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* Drug: Alendronate (Fosamax)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 Alendronate for 12 months, post study<br>Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved. | Drug: Alendronate (Fosamax)<br>* 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.<br>* Other names: Fosamax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). | 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. | Post study (1-6 yrs), one clinical visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). | 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. | Post study (1-6 years), one clincial visit | 
| Number of Participants With Fracture | 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. | Post study (1-6 years), one clinical visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Osteoporosis, Bone Mineral Density, Fosamax, Dual Energy X-Ray Absorptiometry, Fracture