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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 21, 2009
Last Updated Date	June 17, 2012
Start Date ^ICMJE	September 2008
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00982371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 22, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Investigation Into Bone Micro-architecture in Women With Type 2 Diabetes
Official Title ^ICMJE	A Cross-sectional Comparison of Bone Micro-architecture in Postmenopausal Women With Type 2 Diabetes and Age-matched Controls
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	female; >65 years old; BMI >25kg/m2; postmenopausal >5 yrs
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	65 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00982371
Other Study ID Numbers ^ICMJE	REB 08-281
Has Data Monitoring Committee	Yes
Responsible Party	McMaster University ( Hamilton Health Sciences Corporation )
Study Sponsor ^ICMJE	Hamilton Health Sciences Corporation
Collaborators ^ICMJE	Canadian Institutes of Health Research (CIHR) McMaster University
Investigators ^ICMJE	Not Provided
Information Provided By	McMaster University
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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