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Completed

NCT Number: NCT00982371

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: MRI scan complete approximately 1 month after participant is enrolled

Secondary outcomes

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

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 23, 2009
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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