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

NCT ID: NCT00982371

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

REB 08-281

Identifier Type: -

Identifier Source: org_study_id