Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Retrospective Study: Hip Fractures in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puar Hai Kiat Troy, Changi General Hospital
ClinicalTrials.gov Identifier:
NCT01379690
First received: June 22, 2011
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Hip Fractures
Other: HBA1C

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Association of HBA1C and Hip Fractures in Elderly Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • Hip Fracture [ Time Frame: 2005-2010 ] [ Designated as safety issue: No ]
    Admission for hip fracture


Enrollment: 1162
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Used level of HBA1C as a reflection of glycaemic control of the cases and controls
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
Used level of HBA1C as a reflection of glycaemic control of the cases and controls

Detailed Description:

This was a retrospective case-control study. All patients with T2DM admitted with a primary diagnosis of hip fracture and a A1c performed within 3 months of the event admitted to Changi General Hospital, Singapore from 1st Jan 2005 to 31st Dec 2010were included in the study. As the present study was targeted at looking at an association between the glucose lowering effect of medications on A1C levels and subsequent hip fracture risk, exclusion criteria included patients who wereduplicate cases, traumatic fractures, newly diagnosed T2DM patients, and those on diet control.

The information on discharge diagnosis was taken from the Discharge Register of the Hospital. It includes all diagnosis of the patient upon discharge. The diagnosis of patients is coded using the International Classification of Diseases (ICD) system. All patients admitted with the diagnosis of neck of femur fracture (8208 ICD-9), inter-trochanteric fracture (82021 ICD-9), sub-trochanteric fracture (82022 ICD-9), transcervical fracture (82003 ICD-9), and a secondary diagnosis of diabetes (250 ICD-9) were identified from the register.

Out of 932 patients initially identified, 31 were duplicates, 10 were admitted for a traumatic fracture, 136 had no recent A1C level. Of the remaining 757 patients, 162 on diet control and 12 newly diagnosed with diabetes were excluded. The final list of cases consisted of 581 patients, 157 men and 427 women, mean age 76.3 ± 8.7 years.

Controls were selected from a register of patients managed for diabetes from a similar period (1st Jan 2005 to 31st Dec 2010) at Changi General Hospital outpatient clinics (N=4,522). For each case, one control subject, matched for sex and within 2 years of age, was randomly selected from the register. Inclusion criteria included patients taking oral hypoglycemic agents or insulin, and exclusion criteria were patients with a history of hip fractures.

Information on the baseline characteristics and exposure variables were collected by the same methods in cases and control subjects, using the computerised medical records and discernment of the medical notes.

The study was performed in accordance with the Declaration of Helsinki.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Traumatic fractures
  • on diet control for diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379690

Locations
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Troy H Puar, MRCP Changi General Hospital
  More Information

Publications:
Responsible Party: Puar Hai Kiat Troy, Medical Doctor, Changi General Hospital
ClinicalTrials.gov Identifier: NCT01379690     History of Changes
Other Study ID Numbers: ChangiGH
Study First Received: June 22, 2011
Last Updated: February 21, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Changi General Hospital:
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Fractures, Bone
Hip Fractures
Diabetes Mellitus
Endocrine System Diseases
Femoral Fractures
Glucose Metabolism Disorders
Hip Injuries
Leg Injuries
Metabolic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014