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

Sponsor:

Information provided by:

FDA Office of Orphan Products Development

Study Description

Brief Summary:

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

Detailed Description:

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Primary Purpose:	Treatment
Study Start Date :	October 1998
Study Completion Date :	September 2002

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Osteoporosis

Drug Information available for: Alendronate sodium

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599-7070

Sponsors and Collaborators

University of North Carolina

Investigators


Study Chair:	Robert Aris	University of North Carolina

More Information


ClinicalTrials.gov Identifier:	NCT00004489 History of Changes
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

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:


Fibrosis Cystic Fibrosis Osteoporosis 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 Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents

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