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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982371
• Other study ID #: REB 08-281
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: June 17, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Institutes of Health Research (CIHR), McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity		baseline	No

External Links

•   We are the Centre for Appendicular MRI Studies, located in Hamilton, Ontario, Canada.