Status:
COMPLETED
Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Centre hospitalier de l'Université de Montréal (CHUM)
London Health Sciences Centre
Conditions:
Cystic Fibrosis
Osteoporosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00157690
Start Date
December 1 2003
End Date
August 1 2006
Last Update
October 23 2008
Active Locations (6)
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1
Dr. Harvey Rabin - Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
2
McMaster University
Hamilton, Ontario, Canada
3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
4
Centre de Recherche - CHUM
Montreal, Quebec, Canada, H2W 1T7