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Automated High-Speed Film Digitization Method with Quality Assurance
Abstracts Poster Number 162
241 Clinical Study Recruitment
MOTION STUDY OF ONCE-MONTHLY IBANDRONATE VERSUS ONCE-WEEKLY ALENDRONATE: RATIONALE AND DESIGN F Cosman, MD, Medical Director of the Clinical Research Center, NY, USA JA Simon, Clinical Professor, Osteoporosis Diagnostic and Monitoring Center, George Washington University, Washington, DC; RR Recker, Professor of Medicine and Director, Osteoporosis Research Center, Creighton University, Omaha, NE Ibandronate and alendronate are nitrogen-containing bisphosphonates indicated for the prevention and treatment of postmenopausal osteoporosis. Both have proven efficacy in reducing fractures, increasing bone mineral density (BMD), and suppressing biochemical markers of bone turnover. Until now, there have been no head-to-head studies comparing their efficacy and safety. MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis interventioN) is a 1-year randomized, multinational, double-dummy, Phase IIIb trial designed to demonstrate the non-inferiority of once-monthly oral ibandronate (150 mg) versus once-weekly oral alendronate (70 mg). The study population comprises approximately 1,800 postmenopausal women aged 55–84 years with lumbar spine BMD T-scores between 22.5 and 25.0. Co-primary efficacy endpoints are relative change from baseline in mean lumbar spine (L2–L4) and total hip BMD at 12 months. The margin of clinical equivalence is set at 1.41% for lumbar spine and 0.87% for total hip BMD, respectively. Secondary efficacy endpoints include absolute changes at 12 months from baseline in mean lumbar spine BMD and total hip BMD, relative and absolute changes from baseline in trochanter BMD. Approximately 30% of patients are being assessed for relative and absolute changes from baseline in bone-resorption marker C-telopeptide crosslinks of type I collagen and bone-formation marker procollagen type 1 N-terminal propeptide. Clinical vertebral and non-vertebral fractures are being assessed as adverse events, and safety laboratory parameters are being monitored. Comparative data for monthly ibandronate and weekly alendronate should enable better-informed decisions for the choice of treatment of women with postmenopausal osteoporosis.
Poster Number 163
Clinical Study Recruitment
RELATIONSHIP BETWEEN DELAYED MENARCHE AND BONE MINERALIZATION IN PATIENTS AFFECTED BY JUVENILE IDIOPATHIC ARTHRITIS (JIA) Alfredo Maria, MD, Istituto Ortopedico Gaetano Pini Milan Italy B Teruzzi, Istituto Ortopedico Gaetano Pini, Milan; R Cimaz, Istituto Ortopedico Gaetano Pini, Milan; V Gerloni, Istituto Ortopedico Gaetano Pini, Milan Abstract Background: Puberty is an essential step in bone mass accrual. Growth failure and impairment of sexual maturation are frequent manifestations of chronic illnesses in pediatric population, and chronic rheumatologic disorders such as juvenile idiopathic arthritis (JIA) are no exception to this. Methods: The aim of our study was to prospectively evaluate bone density in adolescents females with JIA, and to correlate results with clinical variables, in particular with age at menarche. Lumbar spine (L2–L4) bone mineral density (BMD) (assessed by Dual X-ray Absorbiometry, DXA) was monitored every 6–12 months in a group of 38 girls with JIA. The evaluated bone mass accrual during the peripubertal time as well as absolute and relative (Z score) BMD in relationship with age at menarche, mother s age at menarche, JIA type, disease activity (as evaluated by ESR and Hgb), body mass index (BMI) and corticosteroid treatment (mean pro kg daily dose, cumulative dose) was assessed. Results: Patients were divided into two groups: - group I included girls with menarche age within normal limits for italian standards; - group II included girls with delayed menarche. The BMD values and Z scores in group I were not significantly different to normal population. The BMD values and Z scores in group II were significantly decreased when compared to the normal population (p ! 0.001). With a multivariate analysis only age at menarche seemed independently related to peripubertal mineralization (p 5 0.025, r between 0.65 and 0.75). With a binary logistic analysis only disease activity (ESR and Hgb values) seems indipendently related to a menarche delay (OR 1.16 for each mm/h).
Journal of Clinical Densitometry
Conclusion:Our data show a critical role for disease activity in determination of a regular pubertal onset, and a normal age at menarche in determination of optimal bone mineralization.
Poster Number 164
Clinical Study Recruitment
AUTOMATED HIGH-SPEED FILM DIGITIZATION METHOD WITH QUALITY ASSURANCE EE Eric Lee, Staff Research Associate, University of California, CA USA Chyi Huang, Staff Research Associate, University of California, San Francisco; Serghei Malkov, Associate Specialist, PhD, University of California, San Francisco; Jeff Wang, Staff Research Associate, University of California, San Francisco; Li Wang, Staff Research Associate, University of California, San Francisco, John Shepherd, Assistant Professor in Residence, PhD, University of California, San Francisco With emerging digital imaging technologies, many clinics are beginning to take advantage of digital images in their studies. However, there are a large numbers of existing x-ray films, such as lateral spine films collected for fracture studies that are enormously useful for retrospective analysis with modern digital analysis tools. This can be efficiently done with high quality radiographic film digitizers. The UCSF Breast and Bone Density Group has developed a digitizing system for completely automated high-speed digitization with complementary quality assurance reports. Our purpose here is to present the description of a novel method and its quality control results for 6 months of use. Our Matlab-controlled algorithm has features of automated barcode recognition and film tag blinding, and can digitize films up to 14 17 at pixel resolutions of 50 to 170 microns with a clinical optical density range of 0 to 3.85 in 16 bit depth gray scale. The throughput is up to 800 films/day. The automatic quality assurance system is augmented with a manual QC interface for additional code entry if needed. An automatic QA report for each digitized image is generated including various film parameters and information obtained by optical character recognition. Recently we implemented our automatic digitization method in the MrOS (Osteoporosis in Men Study) and SOF (The Study of Fractures) studies and have successfully digitized various sizes of conventional spine, hip, and hand x-rays into DICOM format. We conclude that our automatic digitization method with its automatic QA technique is a useful mechanism for radiologists to utilize digital image processing tools, and for secure archival.
Poster Number 165
Epidemiology
THE INCIDENCE OF UNDIAGNOSED OSTEOPOROSIS AND OSTEOPENIA IN A COMMUNITY GENERAL ORTHOPEDIC REFERRAL PRACTICE Margaret M Baker, MD, Orthopedic Surgeon, Center for Bone & Joint Surgery, WA USA Kathleen O’Neill, PA-C, Physician Assistant, Center for Bone & Joint Surgery Introduction: Osteoporosis and related fractures are epidemic today in the U.S. and other developed countries. Unfortunately, despite current accurate diagnostic methods and effective preventative treatments many American s bone health issues are not optimally addressed. Methods: Patients meeting NOF or ISCD guidelines for DXA screening were selected from a general orthopedic referral practice over a year period. Four hundred and seventy five patients met inclusion criteria, and were scanned on our Hologic Delphi DXA. The two technologists and clinical densitometrist are ISCD Certified, and precision of 98.54% was established. Testing included spine, hip and forearm BMDs plus lateral vertebral assessment, which we consider our gold standard scan. Results: The incidence of previously undiagnosed osteopenia / osteoporosis in males meeting screening criteria was 70%. A comparison was made between our gold standard scan, and the usual central (hip and spine only) DXA routinely accomplished at other local scanners. Without scanning the forearm and lateral spine, the false negative rate was 34%. Discussion and Conclusion: Even in a specialty referral only setting, patients sent to us most frequently have not had adequate bone health screening. Males and Native Americans were particularly underserved populations in terms of bone health screening. We as orthopedic surgeons have a unique opportunity as bone specialists in our communities to intervene: not only to treat, but also to prevent fractures. Integrating a preventative bone health program in an orthopedic surgical practice is rewarding in many ways, and allows effective diagnosis, treatment, and fracture prevention.
Volume 9, 2006
241 Clinical Study Recruitment
MOTION STUDY OF ONCE-MONTHLY IBANDRONATE VERSUS ONCE-WEEKLY ALENDRONATE: RATIONALE AND DESIGN F Cosman, MD, Medical Director of the Clinical Research Center, NY, USA JA Simon, Clinical Professor, Osteoporosis Diagnostic and Monitoring Center, George Washington University, Washington, DC; RR Recker, Professor of Medicine and Director, Osteoporosis Research Center, Creighton University, Omaha, NE Ibandronate and alendronate are nitrogen-containing bisphosphonates indicated for the prevention and treatment of postmenopausal osteoporosis. Both have proven efficacy in reducing fractures, increasing bone mineral density (BMD), and suppressing biochemical markers of bone turnover. Until now, there have been no head-to-head studies comparing their efficacy and safety. MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis interventioN) is a 1-year randomized, multinational, double-dummy, Phase IIIb trial designed to demonstrate the non-inferiority of once-monthly oral ibandronate (150 mg) versus once-weekly oral alendronate (70 mg). The study population comprises approximately 1,800 postmenopausal women aged 55–84 years with lumbar spine BMD T-scores between 22.5 and 25.0. Co-primary efficacy endpoints are relative change from baseline in mean lumbar spine (L2–L4) and total hip BMD at 12 months. The margin of clinical equivalence is set at 1.41% for lumbar spine and 0.87% for total hip BMD, respectively. Secondary efficacy endpoints include absolute changes at 12 months from baseline in mean lumbar spine BMD and total hip BMD, relative and absolute changes from baseline in trochanter BMD. Approximately 30% of patients are being assessed for relative and absolute changes from baseline in bone-resorption marker C-telopeptide crosslinks of type I collagen and bone-formation marker procollagen type 1 N-terminal propeptide. Clinical vertebral and non-vertebral fractures are being assessed as adverse events, and safety laboratory parameters are being monitored. Comparative data for monthly ibandronate and weekly alendronate should enable better-informed decisions for the choice of treatment of women with postmenopausal osteoporosis.
Poster Number 163
Clinical Study Recruitment
RELATIONSHIP BETWEEN DELAYED MENARCHE AND BONE MINERALIZATION IN PATIENTS AFFECTED BY JUVENILE IDIOPATHIC ARTHRITIS (JIA) Alfredo Maria, MD, Istituto Ortopedico Gaetano Pini Milan Italy B Teruzzi, Istituto Ortopedico Gaetano Pini, Milan; R Cimaz, Istituto Ortopedico Gaetano Pini, Milan; V Gerloni, Istituto Ortopedico Gaetano Pini, Milan Abstract Background: Puberty is an essential step in bone mass accrual. Growth failure and impairment of sexual maturation are frequent manifestations of chronic illnesses in pediatric population, and chronic rheumatologic disorders such as juvenile idiopathic arthritis (JIA) are no exception to this. Methods: The aim of our study was to prospectively evaluate bone density in adolescents females with JIA, and to correlate results with clinical variables, in particular with age at menarche. Lumbar spine (L2–L4) bone mineral density (BMD) (assessed by Dual X-ray Absorbiometry, DXA) was monitored every 6–12 months in a group of 38 girls with JIA. The evaluated bone mass accrual during the peripubertal time as well as absolute and relative (Z score) BMD in relationship with age at menarche, mother s age at menarche, JIA type, disease activity (as evaluated by ESR and Hgb), body mass index (BMI) and corticosteroid treatment (mean pro kg daily dose, cumulative dose) was assessed. Results: Patients were divided into two groups: - group I included girls with menarche age within normal limits for italian standards; - group II included girls with delayed menarche. The BMD values and Z scores in group I were not significantly different to normal population. The BMD values and Z scores in group II were significantly decreased when compared to the normal population (p ! 0.001). With a multivariate analysis only age at menarche seemed independently related to peripubertal mineralization (p 5 0.025, r between 0.65 and 0.75). With a binary logistic analysis only disease activity (ESR and Hgb values) seems indipendently related to a menarche delay (OR 1.16 for each mm/h).
Journal of Clinical Densitometry
Conclusion:Our data show a critical role for disease activity in determination of a regular pubertal onset, and a normal age at menarche in determination of optimal bone mineralization.
Poster Number 164
Clinical Study Recruitment
AUTOMATED HIGH-SPEED FILM DIGITIZATION METHOD WITH QUALITY ASSURANCE EE Eric Lee, Staff Research Associate, University of California, CA USA Chyi Huang, Staff Research Associate, University of California, San Francisco; Serghei Malkov, Associate Specialist, PhD, University of California, San Francisco; Jeff Wang, Staff Research Associate, University of California, San Francisco; Li Wang, Staff Research Associate, University of California, San Francisco, John Shepherd, Assistant Professor in Residence, PhD, University of California, San Francisco With emerging digital imaging technologies, many clinics are beginning to take advantage of digital images in their studies. However, there are a large numbers of existing x-ray films, such as lateral spine films collected for fracture studies that are enormously useful for retrospective analysis with modern digital analysis tools. This can be efficiently done with high quality radiographic film digitizers. The UCSF Breast and Bone Density Group has developed a digitizing system for completely automated high-speed digitization with complementary quality assurance reports. Our purpose here is to present the description of a novel method and its quality control results for 6 months of use. Our Matlab-controlled algorithm has features of automated barcode recognition and film tag blinding, and can digitize films up to 14 17 at pixel resolutions of 50 to 170 microns with a clinical optical density range of 0 to 3.85 in 16 bit depth gray scale. The throughput is up to 800 films/day. The automatic quality assurance system is augmented with a manual QC interface for additional code entry if needed. An automatic QA report for each digitized image is generated including various film parameters and information obtained by optical character recognition. Recently we implemented our automatic digitization method in the MrOS (Osteoporosis in Men Study) and SOF (The Study of Fractures) studies and have successfully digitized various sizes of conventional spine, hip, and hand x-rays into DICOM format. We conclude that our automatic digitization method with its automatic QA technique is a useful mechanism for radiologists to utilize digital image processing tools, and for secure archival.
Poster Number 165
Epidemiology
THE INCIDENCE OF UNDIAGNOSED OSTEOPOROSIS AND OSTEOPENIA IN A COMMUNITY GENERAL ORTHOPEDIC REFERRAL PRACTICE Margaret M Baker, MD, Orthopedic Surgeon, Center for Bone & Joint Surgery, WA USA Kathleen O’Neill, PA-C, Physician Assistant, Center for Bone & Joint Surgery Introduction: Osteoporosis and related fractures are epidemic today in the U.S. and other developed countries. Unfortunately, despite current accurate diagnostic methods and effective preventative treatments many American s bone health issues are not optimally addressed. Methods: Patients meeting NOF or ISCD guidelines for DXA screening were selected from a general orthopedic referral practice over a year period. Four hundred and seventy five patients met inclusion criteria, and were scanned on our Hologic Delphi DXA. The two technologists and clinical densitometrist are ISCD Certified, and precision of 98.54% was established. Testing included spine, hip and forearm BMDs plus lateral vertebral assessment, which we consider our gold standard scan. Results: The incidence of previously undiagnosed osteopenia / osteoporosis in males meeting screening criteria was 70%. A comparison was made between our gold standard scan, and the usual central (hip and spine only) DXA routinely accomplished at other local scanners. Without scanning the forearm and lateral spine, the false negative rate was 34%. Discussion and Conclusion: Even in a specialty referral only setting, patients sent to us most frequently have not had adequate bone health screening. Males and Native Americans were particularly underserved populations in terms of bone health screening. We as orthopedic surgeons have a unique opportunity as bone specialists in our communities to intervene: not only to treat, but also to prevent fractures. Integrating a preventative bone health program in an orthopedic surgical practice is rewarding in many ways, and allows effective diagnosis, treatment, and fracture prevention.
Volume 9, 2006