- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157690
Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
October 22, 2008 updated by: McMaster University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Dr. Harvey Rabin - Health Sciences Centre
-
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Ontario
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Hamilton, Ontario, Canada
- McMaster University
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London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H2X 2P4
- Montreal Chest Institute
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Montreal, Quebec, Canada, H2W 1T7
- Centre de Recherche - CHUM
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Sainte-Foy, Quebec, Canada, G1V 4G2
- CHUL Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CF; confirmed by a positive sweat test or DNA analysis
- age 18 years or above at the time of informed consent
- 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
- provision of informed consent
Exclusion Criteria:
- endoscopy-proven esophagitis, gastritis, ulceration, or abnormalities of the esophagus which delay esophageal emptying such as stricture, achalasia, or esophageal varices
- significantly impaired renal function; this is defined as serum creatinine >177 umol/L
- 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
- history of prior organ transplantation
- 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
- participation in another clinical trial 30 days prior to enrolment or within 6 half-lives of the study drug if applicable
- pregnancy, lactation, or a desire to become pregnant; safe effective birthcontrol must be used
- know hypersensitivity or abnormal reaction to study drug or other bisphosphonates
- 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
- 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
- use of systemic corticosteroids at a dose of at least 7.5 mg/day or greater within last 6 months
- concomitant use of any investigational drug other than the study medication
- 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
- hypocalcemia from any cause, corrected for low albumin
- 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
- poor medical or psychiatric risk for treatment with an investigational drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
70 mg 1 x weekly for 12 months
|
Active Comparator: 1
Alendronate
|
70 mg 1x weekly for 12 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
|
To determine health-related quality of life (HRQL) using the SF-36 instrument.
Time Frame: 12 months
|
12 months
|
To determine HRQL using the Cystic Fibrosis Questionnaire (CFQ).
Time Frame: 12 months
|
12 months
|
To determine the safety of 70 mg of alendronate given once weekly compared with placebo in adult CF patients
Time Frame: 12 months
|
12 months
|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aris RM, Merkel PA, Bachrach LK, Borowitz DS, Boyle MP, Elkin SL, Guise TA, Hardin DS, Haworth CS, Holick MF, Joseph PM, O'Brien K, Tullis E, Watts NB, White TB. Guide to bone health and disease in cystic fibrosis. J Clin Endocrinol Metab. 2005 Mar;90(3):1888-96. doi: 10.1210/jc.2004-1629. Epub 2004 Dec 21.
- Aris RM, Lester GE, Caminiti M, Blackwood AD, Hensler M, Lark RK, Hecker TM, Renner JB, Guillen U, Brown SA, Neuringer IP, Chalermskulrat W, Ontjes DA. Efficacy of alendronate in adults with cystic fibrosis with low bone density. Am J Respir Crit Care Med. 2004 Jan 1;169(1):77-82. doi: 10.1164/rccm.200307-1049OC. Epub 2003 Oct 16.
- Papaioannou A, Kennedy CC, Freitag A, Ioannidis G, O'Neill J, Webber C, Pui M, Berthiaume Y, Rabin HR, Paterson N, Jeanneret A, Matouk E, Villeneuve J, Nixon M, Adachi JD. Alendronate once weekly for the prevention and treatment of bone loss in Canadian adult cystic fibrosis patients (CFOS trial). Chest. 2008 Oct;134(4):794-800. doi: 10.1378/chest.08-0608. Epub 2008 Jul 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
October 23, 2008
Last Update Submitted That Met QC Criteria
October 22, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Pancreatic Diseases
- Fibrosis
- Osteoporosis
- Cystic Fibrosis
- Bone Diseases
- Bone Diseases, Metabolic
- Metabolic Diseases
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Alendronate
Other Study ID Numbers
- MK-0217 Protocol 214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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