Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis Clinical research trials and Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis clinical trial. Human subjects often obtain the finest healthcare possible for their Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.

Home > "R" Clinical Trials Conditions > Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

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



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

For Condition: Osteoporosis,Cystic Fibrosis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of North Carolina
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 60

Location and Contact Information:

Overall Study Official:
RobertAris,  Study Chair,  University of North Carolina

University of North Carolina School of Medicine *Recruiting*
Chapel Hill,  North Carolina,  27599-7070
United States
Recruiting Robert  Aris 919-966-2531


Additional Information:
Study ID Numbers:  199/14270;  UNCCH-FDR001518
Study Start Date: October 1998
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004489

Other Osteoporosis Studies:
1. A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis

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

3. Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

4. Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients with Cystic Fibrosis

5. Interferon gamma-1b by inhalation for the treatment of patients with cystic fibrosis

Related Studies:

Other Osteoporosis Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials

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

  Other Osteoporosis Clinical Trials
  Other North Carolina Clinical Trials
  Other Chapel Hill Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103