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Clinical Trial Details

A pilot study to assess bone mineral density (BMD) by digital X­ray radiogrammetry (DXR) in women undergoing mammography, and comparison with BMD by dual energy X­ray absorptiometry (DXA)

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Trial Information

Broad Health Condition Musculoskeletal

Specific Health ConditionOsteoporosis

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Westmead Hospital - Westmead


Postcode
2145 - Westmead

Anticipated date of first participant enrolment6/08/2014

Anticipated date of last participant enrolment6/08/2014

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial summary

This project is a pilot study that aims to evaluate the accuracy of digital X­ray radiogrammetry (DXR) in determining bone mineral density (BMD), as compared to BMD by dual energy X­ray absorptiometry (DXA). Participants will be women aged fifty years or older who are postmenopausal and are attending for a follow up mammogram.

DXR is a method that can be used to estimate BMD from plain digital hand X­ray images. It assesses BMD from images of the mid 2nd, 3rd and 4th metacarpals. The data is then transmitted in deidentified fashion to Sectra, a Swedish company that has developed the ‘OneScreen’ technology, that combines both mammography and digital X­ ray radiogrammetry. A BMD in g/cm2, a T­score and a Z­score are then transmitted back within minutes. A number of studies have demonstrated that T and Z­scores derived from such DXR examinations correlate closely to values derived by DXA, which is considered the gold standard for screening or follow up bone densitometry. BMD by DXR has been shown to predict fracture risk, similarly to DXA.

Women over the age of 50 who are postmenopausal may already have low BMD and are at risk of further BMD reductions. Women who attend for follow up mammography are, in addition, a group who may require breast surgery and possibly aromatase inhibitors that eliminate sex steroid production and increase fracture risk. The addition of a digital hand X­ray for DXR analysis to the mammography examination requires no additional equipment and takes only a few seconds. If DXR is shown to correlate closely to DXA in our local population, it has potential to be used in osteoporosis screening for women who may require aromatase inhibitors. If cost effective, it might even be considered as a screening tool when women attend for routine mammography, because women screened for breast cancer are the same group who may benefit from awareness of low BMD.

After ethical approval of this study and after participants have provided informed consent, data will be collected from women over the age of 50 who are post­menopausal and who present for a second mammogram after having a positive screening mammogram in the community. The women will complete a short questionnaire following which DXR of the hand will be performed immediately after mammography and the DXR images will be transmitted for analysis. This de­identified data is generally returned within 5 minutes with BMD Z and T­scores. 

Participants will also undergo a DXA examination of the forearm, hip and spine to allow a comparison of the DXR measurements. Participants with results by DXA that indicate a BMD in the osteopaenic range will be provided with a letter which can be taken to their general practitioner for further discussion. Any participant with a BMD in the osteoporotic range will be given a letter for their general practitioner who will also be informed of the result by telephone. For participants with T­scores less than ­3 (indicating osteoporotic­range BMD at or greater than 3 standard deviations below the mean), referral to a specialist will also be suggested. While physicians associated with this study will be available to discuss any result with a participant, they will not be involved in ongoing management for ethical reasons.

To date, DXR using the Sectra system has not been used in Australia, but has undergone evaluation at single sites in the UK, Sweden and the USA. If the technique proves accurate for BMD evaluation in this pilot study, wider application for BMD evaluation in women undergoing mammography might be considered. Compared to DXA, it would be more simple and convenient, is lower radiation and may be cost effective enough to consider as a screening tool in either specific circumstances (such as follow up mammography) or for general postmenopausal evaluation.
Eligibility

Key inclusion criteria

All participants included will be women who are postmenopausal and over the age of 50

Minimum age50 Years

GenderFemales

Can Healthy volunteers participate?Yes

Key exclusion criteria

Male, premenopausal, less than 50 years old, physically unable to meet the criteria required for the study
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Breast Cancer Institute (Westmead Hospital)
Primary Sponsor Address: Level 1, Westmead Hospital Cnr Hawkesbury & Darcy Roads Westmead NSW 2145 Australia
Primary Sponsor Country: Australia

Trial IDACTRN12614001230640

Contact person for information and recruitmentDr
Elisabeth Elder
Breast Cancer Institute Westmead Hospital Cnr Hawkesbury and Darcy Roads, Westmead, NSW, 2145
+61 2 98455555

Further information iconelisabeth.elder@bci.org.au
Australia