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Breathing and Bones Initiative

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ClinicalTrials.gov Identifier: NCT01161680
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Fitzgerald, University of British Columbia

Tracking Information
First Submitted Date June 22, 2010
First Posted Date July 13, 2010
Last Update Posted Date October 29, 2018
Study Start Date July 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2010)
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01161680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 12, 2010)
To associate osteoporosis with severity of pulmonary disease in respirology disease patients.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breathing and Bones Initiative
Official Title A Prospective Baseline Assessment of the Risk of Osteoporosis in Patients With Chronic Obstructive Lung Disease and Outcomes After 2 Years; a Pilot Study
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Osteoporosis
  • Obstructive Lung Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 15, 2015)
30
Original Estimated Enrollment
 (submitted: July 12, 2010)
120
Actual Study Completion Date May 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01161680
Other Study ID Numbers H10-00983
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mark Fitzgerald, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Mark FitzGerald, MD University of British Columbia
PRS Account University of British Columbia
Verification Date October 2018