NCT01161680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

June 22, 2010

Last Update Submit

October 25, 2018

Conditions

Keywords

Cross sectional and Longitudinal Observational study

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Osteoporosis Centre of BC (Bone Consultaton and Bone Mineral Density)

Vancouver, British Columbia, V5H 3X8, Canada

Location

The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street

Vancouver, British Columbia, V5Z 1M9, Canada

Location

The Pacific Lung Centre, Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (19)

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    PMID: 16284220BACKGROUND
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    PMID: 17049326BACKGROUND
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    PMID: 18048807BACKGROUND
  • Donaldson 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.

    PMID: 16236847BACKGROUND
  • Jorgensen 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.

    PMID: 16677808BACKGROUND
  • Maggi 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.

    PMID: 19647671BACKGROUND
  • Blake 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.

    PMID: 19647962BACKGROUND
  • Papaioannou 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.

    PMID: 14551675BACKGROUND
  • Wanner A, Chediak AD, Csete ME. Airway mucosal blood flow: response to autonomic and inflammatory stimuli. Eur Respir J Suppl. 1990 Dec;12:618s-623s.

    PMID: 1981675BACKGROUND
  • Leech 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.

    PMID: 2297189BACKGROUND
  • Rossi 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.

    PMID: 1803824BACKGROUND
  • Anderson 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.

    PMID: 19750192BACKGROUND
  • Walsh 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.

    PMID: 12204867BACKGROUND
  • McEvoy 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.

    PMID: 9517579BACKGROUND
  • Bolton 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.

    PMID: 15374843BACKGROUND
  • Vestergaard P, Rejnmark L, Mosekilde L. Fracture risk in patients with chronic lung diseases treated with bronchodilator drugs and inhaled and oral corticosteroids. Chest. 2007 Nov;132(5):1599-607. doi: 10.1378/chest.07-1092. Epub 2007 Sep 21.

    PMID: 17890464BACKGROUND
  • Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.

    PMID: 19581353BACKGROUND
  • Madsen H, Brixen K, Hallas J. Screening, prevention and treatment of osteoporosis in patients with chronic obstructive pulmonary disease - a population-based database study. Clin Respir J. 2010 Jan;4(1):22-9. doi: 10.1111/j.1752-699X.2009.00138.x.

    PMID: 20298414BACKGROUND
  • Brown JP, Josse RG; Scientific Advisory Council of the Osteoporosis Society of Canada. 2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. CMAJ. 2002 Nov 12;167(10 Suppl):S1-34.

    PMID: 12427685BACKGROUND

MeSH Terms

Conditions

OsteoporosisLung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark FitzGerald, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2010

First Posted

July 13, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2011

Study Completion

May 1, 2012

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations