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Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study

6 juni 2011 uppdaterad av: University of California, San Francisco

For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose > 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality.

The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.

Studieöversikt

Studietyp

Observationell

Inskrivning (Förväntat)

40

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • San Francisco, California, Förenta staterna, 94107
        • China Basin Imaging Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Sannolikhetsprov

Studera befolkning

10 healthy postmenopausal women 10 postmenopausal women with Type II Diabetes and without fracture 10 postmenopausal women with Type II Diabetes and with fracture of the long bone of the upper arm, hip, ankle, or foot 10 postmenopausal women with Type II Diabetes with and without fracture

Beskrivning

Inclusion Criteria:

  • Postmenopausal female, 55-75 years old
  • History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
  • Body mass index (BMI) of 19-35
  • Able to move without walkers and without a history of long periods (>3 months) of inactivity
  • Additional Inclusion criteria for fracture participants:
  • Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs.

Exclusion Criteria:

  • Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot
  • Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
  • Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
  • Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior
  • Diabetic patients on rosiglitazone or pioglitazone medications
  • high energy trauma, e.g., due to motor vehicle accidents
  • Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs
  • History of fluoride, bisphosphonate, calcitonin or tamoxifen use
  • History of unstable cardiovascular disease or uncontrolled hypertension
  • MRI contraindications
  • Body mass index greater than 35

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
1
Healthy post-menopausal women
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
2
Diabetic without fracture
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
CT scan of the lower back and hip
3
Diabetic with fracture
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
CT scan of the lower back and hip

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2006

Primärt slutförande (Faktisk)

1 juli 2009

Avslutad studie (Faktisk)

1 juli 2009

Studieregistreringsdatum

Först inskickad

19 juni 2008

Först inskickad som uppfyllde QC-kriterierna

20 juni 2008

Första postat (Uppskatta)

23 juni 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 juni 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juni 2011

Senast verifierad

1 juni 2011

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på magnetic Resonance Imaging

3
Prenumerera