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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00157690
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: McMaster University
• Public title: Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients
• Scientific 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
• Date of first enrolment: December 2003
• Target sample size: 56
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00157690
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Jonathan D Adachi, M.D.
• Affiliation: McMaster University

• Name: Andreas Freitag, M.D.
• Affiliation: McMaster University

• Name: Alexandra Papaioannou, M.D.
• Affiliation: McMaster University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoporosis

Bone Diseases, Metabolic

Cystic Fibrosis

Intervention(s)

Drug: Alendronate

Drug: Placebo

Primary Outcome(s)

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(s)

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]

To determine the safety of 70 mg of alendronate given once weekly compared with placebo in adult CF patients [Time Frame: 12 months]

To determine health-related quality of life (HRQL) using the SF-36 instrument. [Time Frame: 12 months]

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]

To determine HRQL using the Cystic Fibrosis Questionnaire (CFQ). [Time Frame: 12 months]

Secondary ID(s)

MK-0217 Protocol 214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

McGill University

Merck Frosst Canada Ltd.

Laval University

London Health Sciences Centre

Centre hospitalier de l'Université de Montréal (CHUM)

University of Calgary