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

NCT00157690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-10-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alendronate

70 mg 1x weekly for 12 months

DRUG

Placebo

70 mg 1 x weekly for 12 months

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • McMaster University

    lead OTHER

Principal Investigators

  • Alexandra Papaioannou, M.D. · McMaster University

  • Andreas Freitag, M.D. · McMaster University

  • Jonathan D Adachi, M.D. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157690 on ClinicalTrials.gov