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

NCT00004489 | Completed

• 2 other identifiers: 199/14270UNCCH-FDR001518
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Cystic Fibrosis

Keywords

cardiovascular and respiratory diseases; cystic fibrosis; disease-related problem/condition; genetic diseases and dysmorphic syndromes; osteoporosis; rare disease

Interventions

alendronate sodium DRUG

calcium carbonate DRUG

cholecalciferol DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina: lead

Study Sites (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7070, United States

Location

MeSH Terms

Conditions

Osteoporosis; Cystic Fibrosis; Respiratory Tract Diseases; Genetic Diseases, Inborn; Rare Diseases

Interventions

Alendronate; Calcium Carbonate; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Robert Aris

  University of North Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: October 1, 1998
• Study Completion: September 1, 2002
• Last Updated: March 25, 2015

Record last verified: 2000-01

Locations

US (1)