DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Cystic Fibrosis

Intervention: alendronate sodium (Drug); calcium carbonate (Drug); cholecalciferol (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of North Carolina

Official(s) and/or principal investigator(s):
Robert Aris, Study Chair, Affiliation: University of North Carolina

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.

Clinical Details

Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Detailed description: 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. Completion date provided represents the completion date of the grant per OOPD records

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): 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

Locations and Contacts

University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7070, United States
Additional Information

Starting date: October 1998
Last updated: March 24, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017