Clinical trial NCT00982371: An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes
Official title: A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
osteoporosis
bone quality
magnetic resonance imaging
fracture
postmenopausal women >65 years old
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McMaster University
First posted: 2009-09-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female; \>65 years old; BMI \>25kg/m2; postmenopausal \>5 yrs

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.


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

Primary outcomes:
measure: 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
timeFrame: MRI scan complete approximately 1 month after participant is enrolled
Secondary outcomes:
measure: Calcium, vitamin D and vitamin K dietary intakes; TUG (sec); grip strength; DXA assessment of hip, lumbar spine, total body; physical activity
timeFrame: baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: