Fractures Clinical Trial
Official title:
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.
Verified date | November 2010 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | October 2010 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | FDA Office of Orphan Products Development, Merck Sharp & Dohme Corp. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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