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Study Name: Alendronate in adults with CF related osteoporosis
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Aris, Robert

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 48
Single / Multi-Center: Single Center
STUDY BACKGROUND INFORMATION:
This study is enrolling male and females with Cystic Fibrosis and low bone density ages 18 to 45 years of age. Some participants will receive calcium and Vitamin D supplements with a placebo daily for one month. Other participants will 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.
Participants are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years.
ELIGIBILITY
Age: >= 18 Years
FEV1: 20 - 90 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00004489?term=Cholecalciferol+and+cystic+fibrosis&rank=5
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
NC
  • University of North Carolina at Chapel Hill (Adult), Chapel Hill, NC, 27599
    Contact Information:
        Shive, Nadia
        Phone: (919) 966-9198
        Email: nadiab@med.unc.edu
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