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An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00982371
First received: September 21, 2009
Last updated: June 17, 2012
Last verified: June 2012

September 21, 2009
June 17, 2012
September 2008
December 2011   (final data collection date for primary outcome measure)
1 Tesla peripheral MRI assessment at non dominant distal radius: Trabecular bone micro-architecture parameters Tb.Th, Tb.Sp, Tb.N, BV/TV, bone CSA, marrow space [ Time Frame: MRI scan complete approximately 1 month after participant is enrolled ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00982371 on ClinicalTrials.gov Archive Site
Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
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An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes
A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls

The number of people with type 2 diabetes is growing. This puts a lot of pressure on the health care systems. Type 2 diabetes is often associated with health problems, like poor eyesight, muscle coordination, muscle strength, and blood flow. Poor bone health may also be a concern for people with type 2 diabetes.

A large proportion of people with type 2 diabetes will break a bone in their lifetime. The risk of this happening in older people with type 2 diabetes is greater than the risk in older people without diabetes. Fracturing a bone can be very painful, and lead to serious consequences, especially if the individual experiences a hip fracture. The elevated fracture risk, seen in those with type 2 diabetes, is puzzling because people with type 2 diabetes often appear to have normal, healthy bones compared to people of the same age without diabetes.

Bone micro-structure, which is not assessed by traditional bone densitometry systems (ie: DXA) contributes to overall bone strength.

The hypothesis of this study is that bone micro-structure is of poorer quality (reduced trabecular thickness, increased trabecular spacing) in postmenopausal women with type 2 diabetes, compared to age-matched control participants.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs

Type 2 Diabetes Mellitus
Not Provided
  • Controls
    female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs; NO clinical diagnosis of type 2 diabetes for >5 years (according to Canadian Diabetes Association criteria)
  • Type 2 Diabetes
    female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs; clinical diagnosis of type 2 diabetes for >5 years (according to Canadian Diabetes Association criteria)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • >= 65 years old
  • postmenopausal for > 5 years (WHO definition of menopause)

Exclusion Criteria:

  • currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride)
  • had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung)
  • have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome)
  • have untreated malabsorption syndrome (ie: Celiac Disease)
  • renal insufficiency (CrCl <30ml/min)
  • hyperparathyroidism, hypoparathyroidism
  • chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily
Female
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00982371
REB 08-281
Yes
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
  • Canadian Institutes of Health Research (CIHR)
  • McMaster University
Not Provided
McMaster University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP