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.
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
Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for
Treatment continues if differences are seen in bone mineral density between the treatment
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
PROTOCOL ENTRY CRITERIA:
- 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)
- Endocrine therapy: At least 3 months since prior corticosteroids
- 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