NCT01379690

Brief Summary

Type 2 DM patients are at increased risk of falls as a consequence of long term hyperglycemic complications including retinopathy and neuropathy, and also as a result of hypoglycaemic therapy. Values of A1C \<= 7% has been shown to increase the risk of falls in elderly T2DM patients . Increased fall risk may explain why T2DM patients are at increased risk of hip fractures , despite having a higher bone mineral density as compared to non-T2DM patients. Given the high morbidity and mortality (25% mortality in 1st year post-fracture) associated with hip fractures , all care must be given to prevent hip fractures in T2DM patients. There is controversial data on T2DM medications and fracture risk. Vestergaard showed that use of metformin and sulphonylureas decreased the risk of all fractures, while there was there was a similar trend with insulin. The present study sought to evaluate the relationship between A1c values and the risk of fractures in treated patients with T2DM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,162

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

June 22, 2011

Last Update Submit

February 21, 2012

Conditions

Keywords

HbA1c

Outcome Measures

Primary Outcomes (1)

  • Hip Fracture

    Admission for hip fracture

    2005-2010

Study Arms (2)

Control

Controls were selected from patients with diabetes on consultation during the year 2005-2010 in specialist clinic, without a previous hip fracture. There was no followup period for these patients. Instead the A1C value upon the point of consultation was used to reflect glycaemic control at the point of consultation

Other: HBA1C

Case

All patients with treated diabetes admitted with primary diagnosis hip fractures from 2005-2010 to Changi General Hospital was included in the study. The A1C at the point of admission was used to reflect the glycaemic control at that point in time. This was a retrospective study and there was no subsequent follow up on patients after the point of admission

Other: HBA1C

Interventions

HBA1COTHER

Used level of HBA1C as a reflection of glycaemic control of the cases and controls

CaseControl

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All diabetic patients on treatment with medications, seen at Changi General Hospital from 2005-2010

You may qualify if:

  • Type 2 Diabetic Patients
  • Hip fracture (Case) or no hip fracture (control)

You may not qualify if:

  • Traumatic fractures
  • on diet control for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

Related Publications (1)

  • Vestergaard P, Rejnmark L, Mosekilde L. Relative fracture risk in patients with diabetes mellitus, and the impact of insulin and oral antidiabetic medication on relative fracture risk. Diabetologia. 2005 Jul;48(7):1292-9. doi: 10.1007/s00125-005-1786-3. Epub 2005 May 21.

    PMID: 15909154BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hip Fractures

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Troy H Puar, MRCP

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 23, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations