OsteoporosisNCT01161680
Breathing and Bones Initiative
An observational study of Osteoporosis and Obstructive Lung Disease, run by University of British Columbia at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporosis, Obstructive Lung Disease
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients will be drawn from specified respirology clinics: The Lung Centre (VCH) and The Pacific Lung Centre (PHC)
Who may be able to join
- men and women over 65 years of age with obstructive airway disease being seen by a respirologist in their clinical practices
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Osteoporosis Centre of BC (Bone Consultaton and Bone Mineral Density)
Vancouver, British Columbia, V5H 3X8
The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street
Vancouver, British Columbia, V5Z 1M9
The Pacific Lung Centre, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6
About this study
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
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.
Read the detailed description
Research Method:
- 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
- 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:
- 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.
- 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.
- Conditions
- Osteoporosis, Obstructive Lung Disease
- Keywords
- Cross sectional and Longitudinal Observational study
- Medical subject headings
- Osteoporosis, Lung Diseases, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.
Secondary outcomes (1)
To associate osteoporosis with severity of pulmonary disease in respirology disease patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Fitzgerald, University of British Columbia
- Investigators
- Mark FitzGerald, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161680
- Sponsor's protocol ID
- H10-00983
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2010
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11.
PubMed 16284220Kjensli A, Mowinckel P, Ryg MS, Falch JA. Low bone mineral density is related to severity of chronic obstructive pulmonary disease. Bone. 2007 Feb;40(2):493-7. doi: 10.1016/j.bone.2006.09.005. Epub 2006 Oct 13.
PubMed 17049326Watz H, Waschki B, Boehme C, Claussen M, Meyer T, Magnussen H. Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study. Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51. doi: 10.1164/rccm.200707-1011OC. Epub 2007 Nov 29.
PubMed 18048807Donaldson GC, Seemungal TA, Patel IS, Bhowmik A, Wilkinson TM, Hurst JR, Maccallum PK, Wedzicha JA. Airway and systemic inflammation and decline in lung function in patients with COPD. Chest. 2005 Oct;128(4):1995-2004. doi: 10.1378/chest.128.4.1995.
PubMed 16236847Jorgensen NR, Schwarz P, Holme I, Henriksen BM, Petersen LJ, Backer V. The prevalence of osteoporosis in patients with chronic obstructive pulmonary disease: a cross sectional study. Respir Med. 2007 Jan;101(1):177-85. doi: 10.1016/j.rmed.2006.03.029. Epub 2006 May 4.
PubMed 16677808Maggi S, Siviero P, Gonnelli S, Schiraldi C, Malavolta N, Nuti R, Crepaldi G; EOLO Study Group. Osteoporosis risk in patients with chronic obstructive pulmonary disease: the EOLO study. J Clin Densitom. 2009 Jul-Sep;12(3):345-52. doi: 10.1016/j.jocd.2009.05.003.
PubMed 19647671Blake GM, Fogelman I. The clinical role of dual energy X-ray absorptiometry. Eur J Radiol. 2009 Sep;71(3):406-14. doi: 10.1016/j.ejrad.2008.04.062. Epub 2009 Aug 3.
PubMed 19647962Papaioannou A, Parkinson W, Ferko N, Probyn L, Ioannidis G, Jurriaans E, Cox G, Cook RJ, Kumbhare D, Adachi JD. Prevalence of vertebral fractures among patients with chronic obstructive pulmonary disease in Canada. Osteoporos Int. 2003 Nov;14(11):913-7. doi: 10.1007/s00198-003-1449-5. Epub 2003 Oct 9.
PubMed 14551675Wanner A, Chediak AD, Csete ME. Airway mucosal blood flow: response to autonomic and inflammatory stimuli. Eur Respir J Suppl. 1990 Dec;12:618s-623s.
PubMed 1981675Leech JA, Dulberg C, Kellie S, Pattee L, Gay J. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis. 1990 Jan;141(1):68-71. doi: 10.1164/ajrccm/141.1.68.
PubMed 2297189Rossi C, Chianchiano N, Bertolino G, Perino A, Cittadini E. Ultrasonography and blood flow velocity waveform assessment in human fetuses. Acta Eur Fertil. 1991 May-Jun;22(3):147-9.
PubMed 1803824Anderson D, Macnee W. Targeted treatment in COPD: a multi-system approach for a multi-system disease. Int J Chron Obstruct Pulmon Dis. 2009;4:321-35. doi: 10.2147/copd.s2999. Epub 2009 Sep 1.
PubMed 19750192Walsh LJ, Lewis SA, Wong CA, Cooper S, Oborne J, Cawte SA, Harrison T, Green DJ, Pringle M, Hubbard R, Tattersfield AE. The impact of oral corticosteroid use on bone mineral density and vertebral fracture. Am J Respir Crit Care Med. 2002 Sep 1;166(5):691-5. doi: 10.1164/rccm.2110047.
PubMed 12204867McEvoy CE, Ensrud KE, Bender E, Genant HK, Yu W, Griffith JM, Niewoehner DE. Association between corticosteroid use and vertebral fractures in older men with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):704-9. doi: 10.1164/ajrccm.157.3.9703080.
PubMed 9517579Bolton CE, Ionescu AA, Shiels KM, Pettit RJ, Edwards PH, Stone MD, Nixon LS, Evans WD, Griffiths TL, Shale DJ. Associated loss of fat-free mass and bone mineral density in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1286-93. doi: 10.1164/rccm.200406-754OC. Epub 2004 Sep 16.
PubMed 15374843
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01161680
- Acronym / sponsor ID
- H10-00983
- Conditions
- Osteoporosis, Obstructive Lung Disease
- Keywords
- Cross sectional and Longitudinal Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients will be drawn from specified respirology clinics: The Lung Centre (VCH) and The Pacific Lung Centre (PHC)
Key inclusion criteria (1 listed)
- men and women over 65 years of age with obstructive airway disease being seen by a respirologist in their clinical practices
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.
1 secondary outcome
To associate osteoporosis with severity of pulmonary disease in respirology disease patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Background: PubMed 16284220Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11.
- Background: PubMed 17049326Kjensli A, Mowinckel P, Ryg MS, Falch JA. Low bone mineral density is related to severity of chronic obstructive pulmonary disease. Bone. 2007 Feb;40(2):493-7. doi: 10.1016/j.bone.2006.09.005. Epub 2006 Oct 13.
- Background: PubMed 18048807Watz H, Waschki B, Boehme C, Claussen M, Meyer T, Magnussen H. Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study. Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51. doi: 10.1164/rccm.200707-1011OC. Epub 2007 Nov 29.
- Background: PubMed 16236847Donaldson GC, Seemungal TA, Patel IS, Bhowmik A, Wilkinson TM, Hurst JR, Maccallum PK, Wedzicha JA. Airway and systemic inflammation and decline in lung function in patients with COPD. Chest. 2005 Oct;128(4):1995-2004. doi: 10.1378/chest.128.4.1995.
- Background: PubMed 16677808Jorgensen NR, Schwarz P, Holme I, Henriksen BM, Petersen LJ, Backer V. The prevalence of osteoporosis in patients with chronic obstructive pulmonary disease: a cross sectional study. Respir Med. 2007 Jan;101(1):177-85. doi: 10.1016/j.rmed.2006.03.029. Epub 2006 May 4.
- Background: PubMed 19647671Maggi S, Siviero P, Gonnelli S, Schiraldi C, Malavolta N, Nuti R, Crepaldi G; EOLO Study Group. Osteoporosis risk in patients with chronic obstructive pulmonary disease: the EOLO study. J Clin Densitom. 2009 Jul-Sep;12(3):345-52. doi: 10.1016/j.jocd.2009.05.003.
- Background: PubMed 19647962Blake GM, Fogelman I. The clinical role of dual energy X-ray absorptiometry. Eur J Radiol. 2009 Sep;71(3):406-14. doi: 10.1016/j.ejrad.2008.04.062. Epub 2009 Aug 3.
- Background: PubMed 14551675Papaioannou A, Parkinson W, Ferko N, Probyn L, Ioannidis G, Jurriaans E, Cox G, Cook RJ, Kumbhare D, Adachi JD. Prevalence of vertebral fractures among patients with chronic obstructive pulmonary disease in Canada. Osteoporos Int. 2003 Nov;14(11):913-7. doi: 10.1007/s00198-003-1449-5. Epub 2003 Oct 9.
- Background: PubMed 1981675Wanner A, Chediak AD, Csete ME. Airway mucosal blood flow: response to autonomic and inflammatory stimuli. Eur Respir J Suppl. 1990 Dec;12:618s-623s.
- Background: PubMed 2297189Leech JA, Dulberg C, Kellie S, Pattee L, Gay J. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis. 1990 Jan;141(1):68-71. doi: 10.1164/ajrccm/141.1.68.
- Background: PubMed 1803824Rossi C, Chianchiano N, Bertolino G, Perino A, Cittadini E. Ultrasonography and blood flow velocity waveform assessment in human fetuses. Acta Eur Fertil. 1991 May-Jun;22(3):147-9.
- Background: PubMed 19750192Anderson D, Macnee W. Targeted treatment in COPD: a multi-system approach for a multi-system disease. Int J Chron Obstruct Pulmon Dis. 2009;4:321-35. doi: 10.2147/copd.s2999. Epub 2009 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark FitzGerald, MD principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Obstructive Lung Disease, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of osteoporosis in the respiratory disease population, as determined by bone density and fragility fracture.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161680, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.