Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
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ClinicalTrials.gov Identifier: NCT00004489 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Cystic Fibrosis | Drug: alendronate sodium Drug: calcium carbonate Drug: cholecalciferol | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Primary Purpose: | Treatment |
Study Start Date : | October 1998 |
Study Completion Date : | September 2002 |


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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
ClinicalTrials.gov Identifier: | NCT00004489 |
Other Study ID Numbers: |
199/14270 UNCCH-FDR001518 |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | January 2000 |
cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition |
genetic diseases and dysmorphic syndromes osteoporosis rare disease |
Osteoporosis Cystic Fibrosis Fibrosis 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 Metabolic Diseases |
Cholecalciferol Alendronate Calcium Carbonate Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |