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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	MRI scan complete approximately 1 month after participant is enrolled

Secondary Outcome Measures

Outcome Measure	Time Frame
Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity	baseline

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Canadian Institutes of Health Research (CIHR); McMaster University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 19, 2012
• Last Update Submitted That Met QC Criteria: June 17, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; osteoporosis; type 2 diabetes mellitus; bone quality; fracture; postmenopausal women >65 years old
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: REB 08-281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No