Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2000

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	University of North Carolina
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004489

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.

Condition	Intervention
Osteoporosis Cystic Fibrosis	Drug: alendronate sodium Drug: calcium carbonate Drug: cholecalciferol

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Osteoporosis

Drug Information available for: Cholecalciferol Alendronate Alendronate sodium Fosamax Calcium gluconate Calcium carbonate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	60
Study Start Date:	October 1998

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004489

Locations

United States, North Carolina
University of North Carolina School of Medicine	Recruiting
Chapel Hill, North Carolina, United States, 27599-7070
Contact: Robert Aris 919-966-2531

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of North Carolina

Investigators

Study Chair:

Robert Aris

University of North Carolina

More Information

No publications provided

Study ID Numbers:	199/14270, UNCCH-FDR001518
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004489 History of Changes
Health Authority:	United States: Federal Government

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:

Molecular Mechanisms of Pharmacological Action
Fibrosis
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Carbonate
Bone Diseases
Pathologic Processes
Respiratory Tract Diseases
Musculoskeletal Diseases
Alendronate
Vitamins
Infant, Newborn, Diseases
Micronutrients

Cholecalciferol
Growth Substances
Osteoporosis
Bone Diseases, Metabolic
Pharmacologic Actions
Digestive System Diseases
Genetic Diseases, Inborn
Cystic Fibrosis
Lung Diseases
Osteoporosis, Postmenopausal
Pancreatic Diseases
Antacids

ClinicalTrials.gov processed this record on March 18, 2010