Trial record 1 of 405 for:    diabetes type 2 AND (woman OR women OR female)
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An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00982371
First received: September 21, 2009
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
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
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)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982371

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
McMaster University
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00982371     History of Changes
Other Study ID Numbers: REB 08-281
Study First Received: September 21, 2009
Last Updated: June 17, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
type 2 diabetes mellitus
osteoporosis
bone quality
magnetic resonance imaging
fracture
postmenopausal women >65 years old

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014