Status:
COMPLETED
3D Imaging of the Hip Using DXA
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Medical Research Council
Hologic, Inc.
Conditions:
Osteoporosis
Low-energy Trauma Fracture
Eligibility:
FEMALE
50-85 years
Brief Summary
The study aims to determine the efficacy and best methods for predicting hip fractures and diagnosing post-menopausal osteoporosis using three dimensional structural engineering models (SEMs) of proxi...
Detailed Description
Bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) have been available to the clinician for the past 20 years and their use forms the basis of current clinical practice ...
Eligibility Criteria
Inclusion
- be female
- at least 5 years post menopausal but \<85 years
- be sufficiently mobile to undergo DXA and QCT scanning
- be able and willing to participate in the study and provide written informed consent
Exclusion
- bi-lateral hip replacement
- have hip replacement on the non-fractured side
- have any history of cancer within the past 5 years excluding skin cancer non melanomas
- have a history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
- have a history of chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)
- Acute or chronic hepatic disease
- Malabsorption syndromes
- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- patients who are currently on glucocorticoid therapy
- have a history of any known condition that would interfere with the assessment of DXA or CT of hip
- have markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator
- have participated in another clinical trial involving active therapy 3 months prior to randomisation
- have a known confusional state or dementia as documented in hospital notes, or be unsuitable for approach in the opinion of the physician with duty of care
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00666640
Start Date
May 1 2008
End Date
January 1 2012
Last Update
September 19 2014
Active Locations (1)
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1
Bone Biomedical Research Unit, Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S5 7AU