Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
University of North Carolina
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000

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
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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004489

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
Study Chair: Robert Aris University of North Carolina
  More Information

No publications provided 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
rare disease

Additional relevant MeSH terms:
Cystic Fibrosis
Bone Diseases
Bone Diseases, Metabolic
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Musculoskeletal Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 27, 2015