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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Medical University of South Carolina |
Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00259857 |
We have previously evaluated the safety and efficacy of Fosamax in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Fosamax improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Fosamax in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Condition | Intervention | Phase |
Osteoporosis |
Drug: Alendronate |
Phase II |
MedlinePlus related topics: | Fractures Minerals Osteoporosis |
ChemIDplus related topics: | Alendronate Alendronate sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate (Fosamax) in Juvenile Osteoporosis (IND#60,017) |
Estimated Enrollment: | 20 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Placebo Comparator
Crossover study. Year-1, 10 participants will take study medication and other 10 participants will take placebo. Year-2, they will crossover to the second arm of the study. Those who took study medication in year-1, will take placebo in the year-2, and those 10 participants who took placebo in the year-1, will take study medications in the year-2.
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Drug: Alendronate
dosage form:tablet dosage: 35mg (<40kg body weight) or 70mg (>40kg body weight) at the time of start. frequency: weekly duration:12 months |
1: Placebo Comparator
year-1, 10 participants will take Alendronate (study medication). and another 10 participants will take placebo. In year-2 they will crossover.
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Drug: Alendronate
dosage form:tablet dosage: 35mg (<40kg body weight) or 70mg (>40kg body weight) at the time of start. frequency: weekly duration:12 months |
Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history. The disease results from either diminished bone formation or increased bone removal (resorption). No specific drug therapy has been recommended for juvenile osteoporosis. Alendronate (Fosamax) is effective in inhibiting bone resorption, increasing BMD and reducing fractures in adults with postmenopausal osteoporosis, but have not become established therapies in children. In the present study, we plan to evaluate the safety and efficacy of Fosamax in 20 patients with juvenile osteoporosis in a two-year period. This is a randomized, double-blind, placebo-controlled protocol. In the year-1, 10 patients will be assigned to receive Fosamax and 10 patients placebo. In the year-2, patients will be crossed over to the second arm of the study. Those who received Fosamax in the year-1, will receive placebo in the second year and vice versa. The patients will have 5 visits, the initial screening visit followed by 4 post therapy visits in a six-month interval. Measurements include DEXA of spine and hip, urinalysis and blood work.
Ages Eligible for Study: | 5 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
United States, South Carolina | |||||
Medical University of South Carolina | |||||
Charleston, South Carolina, United States, 29425 |
FDA Office of Orphan Products Development |
Medical University of South Carolina |
Principal Investigator: | Lyndon L Key, M.D. | Medical University of South Carolina |
Medical University of South Carolina, Children's Hospital 
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Responsible Party: | Medical University of South Carolina ( L Lyndon Key, MD, Prof and Chairman ) |
Study ID Numbers: | 5 R01 FD001847-05, FD-R-001847-03, FD-R01-2-0, FD-188-03 |
First Received: | November 29, 2005 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00259857 |
Health Authority: | United States: Food and Drug Administration |
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