Breathing and Bones Initiative

October 25, 2018 updated by: Mark Fitzgerald, University of British Columbia

A Prospective Baseline Assessment of the Risk of Osteoporosis in Patients With Chronic Obstructive Lung Disease and Outcomes After 2 Years; a Pilot Study

This project will examine the current diagnosis and treatment of bone health in patients with obstructive airway disease. Patients will be referred to The Osteoporosis Centre of BC (OCBC) by their respirologist to be assessed for osteoporosis including Dual Energy Xray Absorptiometry (DXA) scan. Previous chest xrays and will be accessed and examined for vertebral fractures, diagnostic of osteoporosis. The lung and bone data will be entered into a database. This will allow us to explore the relationship of lung disease parameters to osteoporosis predictors, eventually determining a respirology patient population who are at high risk of fracture. Longitudinal evaluation of bone health and its relationship to respiratory parameters over time will be explored by follow-up evaluations at 12 and 24 months.

Study Overview

Status

Completed

Conditions

Detailed Description

Research Method:

  1. Selected respirologists' practices will identify patients at risk of osteoporosis (according to Osteoporosis Canada Guidelines):

    1. Who have not had a bone density test in the past 2 years and
    2. Who are not already taking osteoporosis pharmacotherapy.
    3. Other patients not meeting these criteria can also be referred at the discretion of the physician

  2. Patients will be given a choice on whether they wish to be referred to the Osteoporosis Centre of BC (Vancouver) through an expedited simple referral system OR they may have their information sent to their referring/family doctor discussing the need for referral for an evaluation of bone health and follow up

    i. Informed consent obtained with an Ethics Committee approved Informed Consent Form. Informed consent will be obtained from all patients who will be followed by the research team. The consent will allow the researchers to use clinical data and imaging for observational research; participation in the research will be optional and will not affect patient ability to obtain information on their bone health at OCBC.

ii. A standard, full evaluation will be undertaken on a single visit (DXA bone densitometry, consultation with endocrinologist or geriatrician). Screening for secondary causes of osteoporosis including Vitamin D status through blood tests will occur at a community laboratory. All information obtained from these tests being reviewed by the physicians and clinical treatment decisions will be made based on standard practice.

iii. Densitometry with OCBC research-calibrated DXA will permit meaningful clinical follow-up .

Respirologists' office process:

1. Men and women over age 65 with obstructive airways disease would be asked if they have had a bone density test in the past 2 years and if they are currently taking an osteoporosis therapy (alendronate, risedronate, zoledronate, etidronate, , raloxifene, calcitonin, estrogen)

2 If the answer is no, the respirologists would

Explain standard of care for patients at risk of osteoporosis and then

  1. Recommend to the referring physician that an osteoporosis evaluation be conducted (non-study) or
  2. Ask the patient if they would be interested in taking part of the observational study. If patient wishes to participate a consent form would be given to the subject and the patient would be asked for permission to have the research coordinator call them in 2-3 days to discuss the study. The respirologist would then generate an expedited referral to the Osteoporosis Centre of BC (candidate for observational study).

The research coordinator would contact the subject by telephone and with scripted call speak to the subject and answer any questions pertaining to the study. During this call the research coordinator would determine whether the subject would like to meet prior to the appointment so that informed consent could be obtained. Informed consent would be obtained at the OCBC prior to the patient's appointment. If the patient does not wish to consent to the study but is referred clinically, they will not meet with the study coordinator, but they will still be able to access all usual clinical services provided by OCBC.

i. A simple one-page referral faxed to Osteoporosis Centre of BC

ii. All arrangements made either with respirologists' office or directly with the patient by OCBC

iii. Consultation reports sent back to both the referring doctor (respirology) and family doctor

Data from osteoporosis clinical history, fracture history, medication history, chemistries, and DXA will be collected with data on respiratory function. A database would be made for later analysis and correlation.

Chest Xray films taken in the last 2 years would be reviewed. Chest CT or other imaging will be evaluated for vertebral compression fractures (a very potent risk factor for future fragility fracture).

Statistical Analysis:

This study is observational and descriptive data will be produced. Regressions of continuous variables will be analyzed using Pearson correlation coefficients and parametric variables analyzed by Chi Squared testing.

Study Type

Observational

Enrollment (Actual)

30

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5H 3X8
        • The Osteoporosis Centre of BC (Bone Consultaton and Bone Mineral Density)
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • The Pacific Lung Centre, Providence Health Care

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be drawn from specified respirology clinics: The Lung Centre (VCH) and The Pacific Lung Centre (PHC)

Description

Inclusion Criteria:

  • men and women over 65 years of age with obstructive airway disease being seen by a respirologist in their clinical practices

Exclusion Criteria:

  • less than 65 years of age
  • patient has had bone density scan within the last 2 years
  • patient is currently being treated for osteoporosis (alendronate, risedronate, zoledronate, etidronate, clodronate, raloxifene, calcitonin, estrogen)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.

Secondary Outcome Measures

Outcome Measure
To associate osteoporosis with severity of pulmonary disease in respirology disease patients.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Mark FitzGerald, MD, University of British Columbia

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

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

July 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (ESTIMATE)

July 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00983

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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