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	Treatment or Intervention
Osteoporosis Cystic Fibrosis	Drug: alendronate sodium  Drug: calcium carbonate  Drug: cholecalciferol

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   -   45 Years,  Genders Eligible for Study:  Both

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

North Carolina
      University of North Carolina School of Medicine, Chapel Hill,  North Carolina,  27599-7070,  United States; Recruiting

Study chairs or principal investigators

Robert Aris,  Study Chair,  University of North Carolina   

Study ID Numbers:  199/14270; UNCCH-FDR001518
Record last reviewed:  January 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004489
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09