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

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina
• Treatments: Alendronate; Calcium; Calcium Carbonate; Cholecalciferol

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