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Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
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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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 1998 |
| Estimated Study Completion Date: | September 2002 |
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.
Completion date provided represents the completion date of the grant per OOPD records
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of cystic fibrosis Mild to moderate lung disease
- At least one site specific (spine or femur) bone mineral density representing low bone mass or osteopenia (greater than 1 standard deviation below peak bone mass)
--Prior/Concurrent Therapy--
- Endocrine therapy: At least 3 months since prior corticosteroids
--Patient Characteristics--
- Performance status: Ambulatory
- Renal: Creatinine no greater than 3 mg/dL No renal failure
- Other: No history of esophagitis No allergies to alendronate Not pregnant Fertile female patients must use effective barrier contraception or progestin only oral contraceptives (e.g., norethindrone) Ability to comply with treatment No intestinal problems other than cystic fibrosis
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004489
| United States, North Carolina | |
| University of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 27599-7070 | |
| Study Chair: | Robert Aris | University of North Carolina |
More Information
| ClinicalTrials.gov Identifier: | NCT00004489 History of Changes |
| Other Study ID Numbers: |
199/14270 UNCCH-FDR001518 |
| Study First Received: | October 18, 1999 |
| Last Updated: | March 24, 2015 |
Keywords provided by FDA Office of Orphan Products Development:
|
cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition |
genetic diseases and dysmorphic syndromes osteoporosis rare disease |
Additional relevant MeSH terms:
|
Fibrosis Cystic Fibrosis Osteoporosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Cholecalciferol Alendronate Calcium Carbonate Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 21, 2017