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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

Sponsors and Collaborators: FDA Office of Orphan Products Development
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

Genetics Home Reference related topics:   cystic fibrosis   

MedlinePlus related topics:   Cystic Fibrosis    Osteoporosis   

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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety/Efficacy Study

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


Study ID Numbers:   199/14270, UNCCH-FDR001518
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004489
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

Study placed in the following topic categories:
Cholecalciferol
Fibrosis
Respiration Disorders
Rare Diseases
Osteoporosis
Bone Diseases, Metabolic
Calcium Carbonate
Bone Diseases
Digestive System Diseases
Musculoskeletal Diseases
Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Alendronate
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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