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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00982371

Enrollment

Registered

2009-09-23

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus, osteoporosis, bone quality, magnetic resonance imaging, fracture, postmenopausal women >65 years old

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results