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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of North Carolina |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004489 |
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 |
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Osteoporosis Cystic Fibrosis |
Drug: alendronate sodium Drug: calcium carbonate Drug: 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.
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--
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 |
Study Chair: | Robert Aris | University of North Carolina |
Study ID Numbers: | 199/14270, UNCCH-FDR001518 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004489 History of Changes |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition |
genetic diseases and dysmorphic syndromes osteoporosis rare disease |
Cholecalciferol Fibrosis Respiration Disorders Rare Diseases Osteoporosis Bone Density Conservation Agents Trace Elements Bone Diseases, Metabolic Calcium Carbonate Bone Diseases Calcium, Dietary Digestive System Diseases |
Musculoskeletal Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Alendronate Vitamins Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Antacids Micronutrients |
Cholecalciferol Molecular Mechanisms of Pharmacological Action Fibrosis Growth Substances Physiological Effects of Drugs Osteoporosis Bone Density Conservation Agents Bone Diseases, Metabolic Calcium Carbonate Bone Diseases Pharmacologic Actions Digestive System Diseases |
Pathologic Processes Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Alendronate Vitamins Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Antacids Micronutrients |