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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT00982371

REB 08-281

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Controls

Description:

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

Description:

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)