View Clinical Trial (Medical Research Study)

Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis - NCT00004489-27599(Clinical Trial 112622)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Chapel Hill
State:  
NC
Zip Code: 27599
Conditions: Osteoporosis - Cystic Fibrosis
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.
Study summary: 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.
Criteria: 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
Study is available at: University of North Carolina School of Medicine
Chapel Hill, NC 27599
United States

Primary Contact:
Robert Aris
Phone: 919-966-2531
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.