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

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00982371
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-17
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada