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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004489
• Other study ID #: 199/14270
• Secondary ID: UNCCH-FDR001518
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: October 1998
• Est. completion date: September 2002

Study information

• Verified date: January 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Osteoporosis

Intervention

Drug:
• alendronate sodium

• calcium carbonate

• cholecalciferol

Locations

Country	Name	City	State
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina

Country where clinical trial is conducted

United States,