Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
Recruitment status was Recruiting
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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: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| 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--
- 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 | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7070 | |
| Contact: Robert Aris 919-966-2531 | |
| Study Chair: | Robert Aris | University of North Carolina |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004489 History of Changes |
| Other Study ID Numbers: | 199/14270, UNCCH-FDR001518 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
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:
|
Cystic Fibrosis Fibrosis Osteoporosis Bone Diseases Bone Diseases, Metabolic Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases |
Musculoskeletal Diseases Pancreatic Diseases Pathologic Processes Respiratory Tract Diseases Alendronate Bone Density Conservation Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015