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

Osteoporosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Osteoporosis

Cystic Fibrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:alendronate sodium

Drug:calcium carbonate

Drug:cholecalciferol

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: October 1998

Completed Date: September 2002

Phase: N/A

Type: Interventional

Design:

Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Robert Aris

Lead Sponsor: University of North Carolina

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00004489

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