Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
alendronate sodium
+ calcium carbonate
+ cholecalciferol
Bone Diseases+15
+ Bone Diseases, Metabolic
+ Digestive System Diseases
Treatment Study
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of North Carolina School of Medicine
Chapel Hill, United StatesOpen University of North Carolina School of Medicine in Google Maps