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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of North Carolina |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004489 |
Purpose
OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis.
II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.
| Condition | Intervention |
|
Osteoporosis Cystic Fibrosis |
Drug: alendronate sodium Drug: calcium carbonate Drug: cholecalciferol |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis Osteoporosis |
| Drug Information available for: | Alendronate Alendronate sodium Calcium gluconate Calcium carbonate Cholecalciferol |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 1998 |
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). Patients are randomized to one of two treatment arms.
Patients undergo bioavailability assessment to confirm the ability to absorb alendronate.
Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month.
Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for one month.
Treatment continues if differences are seen in bone mineral density between the treatment arms.
Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years.
Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| United States, North Carolina | |||||
| University of North Carolina School of Medicine | Recruiting | ||||
| Chapel Hill, North Carolina, United States, 27599-7070 | |||||
| Contact: Robert Aris 919-966-2531 | |||||
| FDA Office of Orphan Products Development |
| University of North Carolina |
| Study Chair: | Robert Aris | University of North Carolina |
More Information
| Study ID Numbers: | 199/14270, UNCCH-FDR001518 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004489 |
| Health Authority: | United States: Federal Government |
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