- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01379690
Retrospective Study: Hip Fractures in Diabetic Patients
Association of HBA1C and Hip Fractures in Elderly Type 2 Diabetic Patients
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Singapore, Singapore, 529889
- Changi General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Type 2 Diabetic Patients
- Hip fracture (Case) or no hip fracture (control)
Exclusion Criteria:
- Traumatic fractures
- on diet control for diabetes
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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
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Used level of HBA1C as a reflection of glycaemic control of the cases and controls
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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
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Used level of HBA1C as a reflection of glycaemic control of the cases and controls
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Hip Fracture
Lasso di tempo: 2005-2010
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Admission for hip fracture
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2005-2010
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ChangiGH
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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