Breathing and Bones Initiative
|ClinicalTrials.gov Identifier: NCT01161680|
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : October 29, 2018
|Condition or disease|
|Osteoporosis Obstructive Lung Disease|
Hide Detailed Description
Selected respirologists' practices will identify patients at risk of osteoporosis (according to Osteoporosis Canada Guidelines):
- Who have not had a bone density test in the past 2 years and
- Who are not already taking osteoporosis pharmacotherapy.
- Other patients not meeting these criteria can also be referred at the discretion of the physician
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
- Recommend to the referring physician that an osteoporosis evaluation be conducted (non-study) or
- 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).
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|
|Actual Enrollment :||30 participants|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||May 2012|
- To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.
- To associate osteoporosis with severity of pulmonary disease in respirology disease patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161680
|Canada, British Columbia|
|The Osteoporosis Centre of BC (Bone Consultaton and Bone Mineral Density)|
|Vancouver, British Columbia, Canada, V5H 3X8|
|The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|The Pacific Lung Centre, Providence Health Care|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Mark FitzGerald, MD||University of British Columbia|