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

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ClinicalTrials.gov Identifier: NCT00982371
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease
Type 2 Diabetes Mellitus

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls
Study Start Date : September 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982371

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
McMaster University
More Information

Additional Information:
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00982371     History of Changes
Other Study ID Numbers: REB 08-281
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
type 2 diabetes mellitus
bone quality
magnetic resonance imaging
postmenopausal women >65 years old

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases