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Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157690
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 23, 2008
Centre hospitalier de l'Université de Montréal (CHUM)
London Health Sciences Centre
University of Calgary
McGill University
Laval University
Merck Frosst Canada Ltd.
Information provided by:
McMaster University

Brief Summary:
The primary objective of this study is to determine efficacy of 70 mg alendronate once weekly compared to placebo. This will be measured by percent changes in lumbar spine(LS) bone mineral density(BMD) in adult cystic fibrosis(CF)patients after one year of treatment. The investigators hypothesize that in adult CF patients with osteopenia or osteoporosis, alendronate 70 mg once weekly will produce a mean increase from baseline in lumbar spine BMD that is greater than that observed with placebo at 12 months.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Osteoporosis Bone Diseases, Metabolic Drug: Alendronate Drug: Placebo Phase 4

Detailed Description:
Randomized controled trial have begun to establish the efficacy and safety of bisphosphonates in CF patients with decreased BMD. The development of a once weekly dosing regimen of alendronate and the low prevalence of esophageal adverse events may be an advantageous therapeutic option for this high-risk population. This is a one-year randomized, double-blind, placebo-controlled, multicentre study in 55 CF patients with osteopenia or osteoporosis. Six Canadian centres are participating in this study. Patients randomized to treatment will receive 70 mg oral alendronate once weekly, while controls will receive identical placebo once weekly. All medication dispensed will be concealed. There will be no dose modification during the course of the trial. All patients will receive a total of 1000 mg calcium, 500 through supplementation and 500 through diet. All patients will continue to take vitamin D supplementation ( 2 tablets per day, 400 IU vitamin D/tablet).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis Patients
Study Start Date : December 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Arm Intervention/treatment
Active Comparator: 1
Drug: Alendronate
70 mg 1x weekly for 12 months
Other Name: Fosamax

Placebo Comparator: 2
Drug: Placebo
70 mg 1 x weekly for 12 months

Primary Outcome Measures :
  1. To determine efficacy of 70 mg alendronate once weekly compared to placebo, measured by changes in LS BMD in adult CF patients after one year of treatment [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To determine the efficacy of 70 mg alendronate once weekly compared to placebo measured by percent changes in total hip BMD, proximal femur BMD, and N-telopeptide at one year in adult CF patients. [ Time Frame: 12 months ]
  2. To determine health-related quality of life (HRQL) using the SF-36 instrument. [ Time Frame: 12 months ]
  3. To determine HRQL using the Cystic Fibrosis Questionnaire (CFQ). [ Time Frame: 12 months ]
  4. To determine the safety of 70 mg of alendronate given once weekly compared with placebo in adult CF patients [ Time Frame: 12 months ]
  5. To determine correlations between BMD and patient characteristics, including but not limited to the following: corticosteroid use, height, weight, body mass index BMI) and forced expired volume in 1 minute (FEV1). [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. CF; confirmed by a positive sweat test or DNA analysis
  2. age 18 years or above at the time of informed consent
  3. osteopenia (-2.5< BMD t-score<1.0) or osteoporosis (BMD t-score <-2.5)t-score at the LS (1-4)or total hip
  4. provision of informed consent

Exclusion Criteria:

  1. endoscopy-proven esophagitis, gastritis, ulceration, or abnormalities of the esophagus which delay esophageal emptying such as stricture, achalasia, or esophageal varices
  2. significantly impaired renal function; this is defined as serum creatinine >177 umol/L
  3. current or recent (within 1 year prior to randomization) consumption of an excess of alcohol or abuse of drugs; an excess of alcohol is defined as more than four of any of the following per day, or a combination of more that four of the following per day: 30 mL distilled spirits, 240 mL beer, or 120 mL wine
  4. history of prior organ transplantation
  5. any condition which may interfere with the evaluation of LS BMD as determined in a screening radiograph by a radiologist at the central facility e.g. spinal fusion, confluent aortic calcifications, surgical artefact, excessive osteophytes, or other permanent artefact; hip prostheses or any other condition that may interfere with the evaluation of hip BMD
  6. participation in another clinical trial 30 days prior to enrolment or within 6 half-lives of the study drug if applicable
  7. pregnancy, lactation, or a desire to become pregnant; safe effective birthcontrol must be used
  8. know hypersensitivity or abnormal reaction to study drug or other bisphosphonates
  9. use of drugs know to affect bone within 6 months of starting trial medication (e.g. thiazide, diuretics, calcitonin, calcitriol, anabolic steroids, estrogen or estrogen-related drugs (e.g. tamoxifen, raloxifene, tibolone high dose vaginal estrogen), progesterone, fluoride: this does not include the birth control pill
  10. patients currently receiving another bisphosphonate in whom treatment efficacy has been established; only patients who are intolerant to or did not respond to another bisphosphonate will be considered for inclusion; patients must have ceased treatment with any bisphosphonate for at least 1 year prior to enrolment
  11. use of systemic corticosteroids at a dose of at least 7.5 mg/day or greater within last 6 months
  12. concomitant use of any investigational drug other than the study medication
  13. current or recent (within 1 year prior to randomization) metabolic bone disorders other than secondary osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia (25-OHD<25nmol/L), hypoparathyroidism, hyperparathyroidism; TSH outside normal laboratory range, with values that are assessed as clinically significant by the investigator; if on replacement therapy, dose should be stable and TSH within normal range for a minimum of 6 weeks prior to trial enrolment
  14. hypocalcemia from any cause, corrected for low albumin
  15. any history of cancer; for relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma and patients with a history of successfully treated cervical carcinoma in istu, a documented six-month remission is required before study entry
  16. poor medical or psychiatric risk for treatment with an investigational drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157690

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Canada, Alberta
Dr. Harvey Rabin - Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Canada, Quebec
Centre de Recherche - CHUM
Montreal, Quebec, Canada, H2W 1T7
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
CHUL Hospital
Sainte-Foy, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
McMaster University
Centre hospitalier de l'Université de Montréal (CHUM)
London Health Sciences Centre
University of Calgary
McGill University
Laval University
Merck Frosst Canada Ltd.
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Principal Investigator: Alexandra Papaioannou, M.D. McMaster University
Study Chair: Andreas Freitag, M.D. McMaster University
Study Chair: Jonathan D Adachi, M.D. McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Alexandra Papaioannou, McMaster University Identifier: NCT00157690    
Other Study ID Numbers: MK-0217 Protocol 214
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008
Keywords provided by McMaster University:
Cystic Fibrosis
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Cystic Fibrosis
Metabolic Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs