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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2000 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004489
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000
  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:


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
University of North Carolina
Investigators
Study Chair: Robert Aris University of North Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004489     History of Changes
Other Study ID Numbers: 199/14270, UNCCH-FDR001518
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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:
Cystic Fibrosis
Fibrosis
Osteoporosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Carbonate
Cholecalciferol
Alendronate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014