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Densitometric vertebral fracture assessment using the algorithm-based qualitative method: Baseline fracture predicts incident vertebral fracture at 6-year follow-up
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Abstracts / Bone 48 (2011) S204–S212
e
Early Clin Dev Statistics, MERCK & CO., INC., West Point, USA Modeling and Simulation, MERCK & CO., INC., West Point, USA g Safety Assessment-LAR, MERCK & CO., INC., West Point, USA h Biomedical Engineering, Wright State University, Dayton, OH, USA i Neuroscience, MERCK & CO., INC., West Point, USA j Molecular Endocrinology, MERCK & CO., INC., West Point, USA f
Abstract: This study evaluates the effects of the Cathepsin K inhibitor, odanacatib (ODN) on bone, and compares it to alendronate (ALN) in an osteoporosis prevention mode in the bilateral overiectomized (OVX) rhesus monkey model of estrogen-deficiency. Four imaging modalities were used to monitor bone density and geometrical parameters at baseline, 3, 6, 9, 12, and 18 months in OVX-monkeys (16/group, age 10–22 yrs) treated with vehicle (VEH), ODN (2 mg/kg/d — approx. clinical exposure) or ALN (30 μg/kg/wk). Imaging was performed in the ultradistal (UD) radius, UD tibia, distal radius and distal tibia by HR-pQCT (XtremeCT, Scanco Medical), similar regions by MRI (Siemens TIM Trio), lumbar spine (LS) and proximal femur by QCT (GE-DST), and in standard locations by DXA (GE Lunar iDXA). QCT analysis was performed using Mindways Software modified for non-human primate analysis. HR-pQCT analysis was performed using Scanco's standard method for density and structure, and with expanded versions for direct geometrical measurements and cortical evaluations. An increase in BMD was observed in the clinically relevant locations. Percent increases in BMD compared to VEH at 18 mo (p < 0.001) for ODN and (ALN), (* indicates ODN significantly different from ALN p < 0.05) were: LS aBMD DXA 12.7 (12.6); LS-trabecular vBMD QCT 11.7 (10.5), femoral neck integral vBMD QCT 9.7* (5.6), UD radius aBMD DXA 17.4* (9.1); UD radius integral vBMD HR-pQCT 18.9* (6.9). A striking treatment effect of ODN was an increase in cortical thickness (CtTh) at multiple locations with significant difference from ALN. Percent increases in CtTh compared to VEH at 18 mo (p < 0.001) for ODN and (ALN) were: UD radius HR-pQCT 26.4* (2.8); distal radius HR-pQCT 7.8* (3.6); distal radius MRI 10.6* (4.8); UD tibia HR-pQCT 7.0* (−0.1), distal tibia HR-pQCT 4.5 (1.5), distal tibia MRI 4.1* (0.6), femoral shaft QCT 12.3* (4.4). A significant and steady decrease in endosteal perimeters with ODN treatment suggests bone formation on the endosteal surface. Percent change from baseline at 18 mo for periosteal and endosteal perimeters, respectively for ODN (and ALN) were: UD radius HR-pQCT −0.7 (−0.1), − 7.7* (−1.2); distal radius HR-pQCT 0.5 (0.4), −5.6* (−1.4). In summary, imaging studies have demonstrated that ODN treatment causes a clinically relevant effect in increasing BMD, a robust increase in cortical thickness with significant difference from ALN, and evidence of bone formation on the endosteal surface. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: D. Williams Employee of Merck & Co. Inc., P. McCracken Employee of Merck & Co., Inc. (past); currently Eisai Pharmaceuticals, R. Jayakar Employee of Merck & Co. Inc., M. Purcell Employee of Merck & Co., Inc, P. Mathers Employee of Merck & Co. Inc., A. Savitz Employee of Merck & Co. Inc., J. Szumiloski Employee of Merck & Co. Inc., A. Cabal Employee of Merck & Co. Inc., B. Dardzinski Employee of Merck & Co. Inc., S. Motzel Employee of Merck & Co. Inc., T. Hangartner Consulting fees from Merck & Co. Inc., R. Hargreaves Employee of Merck & Co. Inc., J. Evelhoch Employee of Merck & Co. Inc., L. Duong Employee of Merck & Co. Inc., and J. Cook Employee of Merck & Co. Inc.
doi:10.1016/j.bone.2011.03.468
PP338-M Evaluation of the impact of a case-finding strategy for vertebral fractures on bisphosphonate prescribing in primary care (COSHIBA) E. Clark ⁎, V. Gould, L. Morrison, J. Tobias University of Bristol, Bristol, UK Abstract: Introduction: Patients with vertebral fractures (VFs) are at a high risk of further fractures, have a reduced quality of life and excess mortality. Despite this, only a minority of VFs come to clinical attention. We previously carried out a population-based study to identify risk factors for prevalent VFs that could form the basis for a simple screening tool. To test the utility of this tool, we performed an RCT to determine whether its application in primary care leads to a measurable increase in prescribing of drugs used for prevention of vertebral and other osteoporotic fractures, such as bisphosphonates. Methods: We recruited women from primary care within Bristol, UK (COSHIBA, the Cohort for Skeletal Health in Bristol and Avon). The only eligibility criteria were an age between 65 and 80. Baseline data was collected by selfcompleted questionnaire. Those in the intervention arm received the simple screening tool (reported height loss, history of fracture, Margolis pain score and rib-to-pelvis distance) carried out by a research nurse at their GP practice. If participants were found to be at high risk the research nurse arranged a thoracolumbar X-ray. Results of this X-ray were reported by NHS Consultant Radiologists and the report was sent to the participants GP. Those in the control arm received no additional intervention. Bisphosphonate prescribing at six months was used as the primary outcome. Results: 7080 women were approached out of a total of 8224 eligible and 3200 were recruited (45.2%). 1062 were randomised to the intervention arm. There were no differences between the 2 groups at baseline. Of the 1062 in the intervention arm, 983 were screened (92.6%) and 401 (40.8%) were found to be at high risk and offered an X-ray. At 6 months of follow-up 2446 (76.4%) women were still
in the study. At this time point those in the intervention arm were over 2.5 times more likely to have been prescribed a bisphosphonate since the start of the study compared to those in the control arm (OR 2.58, 95%CI 1.26 to 5.38, P = 0.007). A similar increase was seen when results were analysed for bisphosphonate prescribing at 12 months (OR 2.52, 95%CI 1.19 to 4.05, P = 0.012). Discussion: Six months after our simple screening tool was implemented, we report an increase in bisphosphonate prescribing that was maintained at 12 months. Further analyses are underway to explore the cost effectiveness of this tool in preventing VFs, as a prelude to its wider uptake. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.469
PP339-T Hypoparathyroidism (HP) protects bone mass but is highly associated with lumbar morphometric fracture F.D.A. Pereira ⁎, M.L. Mendonça, M.H. Nogueira-Barbosa, P.C.A. Watanabe, S.R. Teixeira, L.M. Maciel, F.J.A. De Paula Internal Medicine, School of Medicine of Ribeirao Preto, USP, Ribeirao Preto, Brazil Abstract: Objectives: To use different imaging techniques to assess bone mass, bone quality and morphometric vertebral fractures in patients with hypoparathyroidism (HP). Methods: Sixteen women with HP (HPG) and seventeen control women (CG) were evaluated. The following biochemical parameters were determined: calcium, albumin, inorganic phosphorus, alkaline phosphatase, creatinine, parathyroid hormone, 25-OH vitamin D, osteocalcin and IGF-1 in serum, and deoxypyridinoline/creatinine in urine. DXA of L1–L4, femoral neck, total hip, distal 1/3 of the forearm, whole body, and body composition were determined. Vertebral morphometry was performed by measuring the anterior, middle and posterior heights of each vertebra. Morphometric fracture was considered when a difference between height measurements was higher than 20%. Mandibular analysis was performed by measuring the inferior mandibular cortical thickness bilaterally in the region of the mental foramen and of the mandibular angle. Results: Age = 62.3± 8.9 y, weight= 72.6 ± 10.9 kg, height= 1.54 ± 7.87 m, and BMI = 30.3 ± 4.2 kg/m 2 of CG did not differ from those of HPG (age = 58± 6.0 y, weight = 71.7± 13.7 kg, height= 1.58 ±6.4 m and BMI = 28.5 ±55 kg/m 2). Also, there was no significant difference between groups in alkaline phosphatase, 25-OH vitamin D or deoxypyridinoline/creatinine levels. Calcium and osteocalcin levels were significantly lower in HPG. HPG presented bone mineral density similar to that of CG at all sites analyzed (e.g. L1–L4: GH = 1.090 ± 0.3 vs CG = 0.970 ± 0.2 g/cm 2; p = 0.2). HPG had a significantly smaller mandibular cortical thickness at the level of the mental foramen than CG. Regarding vertebral morphometry, the presence of fractures was observed in 11 of HPG subjects (62.5%) and only in 2 of CG subjects (11.7%). Conclusion: The present results indicate that, despite the preservation of bone mass, primary HP seems to be associated with a greater fracture risk, at least at the vertebral level. Mandibular cortical bone seems to be an important site for the assessment of bone involvement in primary HP. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.470
PP340-S Densitometric vertebral fracture assessment using the algorithm-based qualitative method: Baseline fracture predicts incident vertebral fracture at 6-year follow-up L. Ferrar a, ⁎, D. Felsenberg b, C. Roux c, C. Glüer d, R. Eastell a a Bone Biomedical Research Unit, University of Sheffield, Sheffield, UK b Centre of Muscle and Bone Research, Charite-Universitatsmedizin, Berlin, Germany c Centre d'Evaluation des Malades Osseuses, Rene Descartes University, Paris, France d Dept of Diagnostic Radiology, University Hospital Schleswig-Holstein, Kiel, Germany Abstract: Introduction: Baseline vertebral fracture (VF) predicts future fracture. Baseline fracture may be identified by low-radiation densitometric vertebral fracture assessment (VFA). Algorithm-based qualitative (ABQ) diagnosis, which requires evidence of endplate depression to define VF, has not previously been applied in longitudinal VFA. Our aim was to examine the association between ABQ baseline and new (incident) VF identified on VFA. Methods: We evaluated thoraco-lumbar VFA scans obtained by Hologic devices at
Abstracts / Bone 48 (2011) S204–S212 baseline and 6-years in the population-based Osteoporosis and Ultrasound Study (OPUS). We studied 674 women from 3 participating OPUS centres who attended both visits; this sample comprised 73 premenopausal women, aged (at baseline) 21 to 40 years and 601 postmenopausal women aged 55 to 80 years. Scans were evaluated visually by an experienced reader using the ABQ method. Morphometric vertebral measurements were not obtained. Baseline scans were evaluated first (without reference to 6-year scans) to classify women as having (i) ≥ 1 baseline VF (endplate fracture with or without cortical fracture) or (ii) no baseline VF (no endplate fracture and vertebral heights normal or no endplate fracture and ≥ 1 non-fracture short vertebral height). Six-year scans were assessed alongside baseline scans to identify incident VFs. Women were classified as having (i) ≥ 1 incident VF (new VF using same criteria for identification of baseline VF) or (ii) no incident VF. We compared proportions of women with and without baseline VF in the pre- and postmenopausal groups (chi squared test). We calculated the odds ratio (OR) for incident VF in women with baseline VF (logistic regression analysis) and compared within-group characteristics of women with and without VF (2 sample t test). Results: Baseline VF was identified in one premenopausal (1%) and 41 postmenopausal women (7%). Incident VFs were identified in 18 postmenopausal women (3%); there were no incident VFs in premenopausal women. Odds ratios (95% CI) for incident VF in postmenopausal women with baseline VF were as follows: unadjusted OR = 9.31 (2.9, 30.4); OR adjusted for age and BMD = 5.33 (1.41, 20.09). Women with baseline or incident VF were older (P < 0.01) and had lower total hip BMD (P < 0.001) compared to women without VF. Conclusions: Baseline vertebral fracture defined by evidence of endplate depression on VFA is associated with increased risk of incident vertebral fracture in postmenopausal women. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.471
PP341-M Height loss rate as a marker of vitamin D deficiency in men with osteoporosis M. Ignaszak-Szczepaniak a, ⁎, M. Michalak b, J. Dytfeld a, W. Horst-Sikorska a a Department of Family Medicine, Poznan University of Medical Sciences, Poznan, Poland b Department of Computer Science and Statistics, Poznan University of Medical Sciences, Poznan, Poland Abstract: Background: Vertebral fractures often are undiagnosed, while we identify patients with osteoporosis. Their incidences increase with age. Height loss is a frequent manifestation of vertebral fractures and is simple to assess. Vitamin D (VD) has good evidence for fall prevention and reduction of fracture risk. Data are inconclusive for men. The aims of study were: 1. to determine the association between serum 25(OH)D concentration and the degree of height loss, previous fractures and risk of falling in Polish men with osteoporosis and 2. to test the efficacy of vitamin D supplementation in preventing falls. Material and methods: The study group comprised 88 men aged 60–87 years (average age 70 yrs) with BMD T-score at the femoral neck or lumbar spine <−2.5 SD. Collected data included self-reported maximum adult height, measurement of current height, number of falls within last 12 months, previous osteoporotic fractures and VD intake. Vertebral fractures were confirmed by X-ray. We assumed that loss of height over 4 cm may indicate vertebral fracture. Plasma 25(OH)D levels were measured with competitive electro chemiluminescence immunoassay technology (Elecsys, Roche). 25(OH)D < 30 ng/ml was regarded as VD insufficiency. Results: Among 88 men, average height loss was 4.05 cm (ranged 0–14 cm). In 40 men loss of height was >=4 cm that suggests clinically silent vertebral fractures in 60% of patients. Only 15 incidents were symptomatic, confirmed by Xray. 20 men experienced other clinical low energy fractures at different locations and 21 fell at least 1 time. 29% patients took regularly VD (200–800 IU daily). In 98% men 25(OH)D was < 30 ng/ml independently of VD intake. The mean serum level was 19.7 ± 5.35 ng/ml (ranged 4–29), and only 2 patients exceeded required level. 25(OH)D concentration was significantly associated with age (p < 0.001). Elderly men had the lowest 25(OH)D concentration. A loss of height at least 5 cm was significantly associated with low level of VD (p = 0.028). There was no relationship for 4 cm cut off. Low serum 25(OH)D concentration wasn't associated with previous symptomatic fractures or falls. Doses of VD supplementation < 800 IU did not reduce the risk of falling. Conclusions: 1. Height loss of >=5 cm may be an indicator of vitamin D deficiency in men. 2. Vitamin D deficiency had no relation to previous fractures and falls in men. 3. Daily intake of vitamin D < 800 IU does not provide adequate vitamin D status and also may not prevent falls. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.472
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PP342-T Comparison of lateral decubitus and supine lateral vertebral fracture assessment (VFA) techniques M.A. Paggiosi ⁎, J. Finigan, N. Peel, R. Eastell, L. Ferrar Sheffield NIHR Bone Biomedical Research Unit, Northern General Hospital, Sheffield, UK Abstract: Variations in VFA image quality may occur when using different lateral imaging techniques and hence impact on the accuracy of vertebral fracture (VF) diagnosis. Pearson (JCD 2006, 9, 3: 295–301) reported no clinically significant difference in image quality when assessing lateral decubitus and supine lateral images acquired using GE devices. Evidence of VFA image comparisons between Hologic devices, however, is limited. Our aims were to 1) calculate the agreement for identification of prevalent VF and 2) compare the number of i) readable vertebrae imaged and ii) vertebrae projected obliquely when using these techniques. We selected women (n = 49, age = 77.1 ± 6.5 years), with (n = 25) and without (n = 24) prevalent VFs, participating in either the Fracture or Corticosteroid (FOCUS) study, or the Osteoporosis and Ultrasound (OPUS) study. All subjects underwent both lateral decubitus and supine lateral imaging of the thoraco-lumbar spine, using a Delphi C and a Discovery A densitometer, respectively. All images were reviewed by an expert reader blinded to patient identity and fracture status. Agreement for VF definition was determined using kappa (κ) on a patient by patient basis. All VFs were defined by evidence of endplate fracture with or without cortical fracture (algorithm-based qualitative approach). Discordance between the number of vertebrae that i) could be visually assessed and ii) were visually assessed but were projected obliquely, was compared for the two techniques using Wilcoxon paired sample tests. P < 0.05 indicated statistical significance. A total of 637 vertebrae (T4–L4) were examined using each imaging technique. There was good agreement (κ = 0.76, 95% CIs for κ = 0.57, 0.94) for identification of VF. A greater number of vertebrae could be visually assessed on lateral decubitus images (623 vertebrae (97.8%) for lateral decubitus versus 589 vertebrae (92.4%) for supine lateral; p = 0.001), however, more vertebrae were projected obliquely (145 vertebrae (23.3%) for lateral decubitus compared to 93 vertebrae (15.8%) for supine lateral; p = 0.002). To conclude, there was good agreement for the identification of patients with VF on lateral decubitus and supine lateral images. Discordance in image quality may occur due to variations in the number of readable and obliquely projected vertebrae. However, there does not appear to be a significant impact on VF diagnosis. These data therefore support the use of either lateral imaging technique in clinical practice. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: M. Paggiosi: None declared, J. Finigan: None declared, N. Peel: None declared, R. Eastell Grant/Research Support from Eli Lilly, Sanofi-Aventis, Procter & Gamble Pharmaceuticals, Hoffman-La Roche, Pfizer, Novartis, the National Institute for Health Research, and L. Ferrar: None declared. doi:10.1016/j.bone.2011.03.473
PP343-S Beneficial effects of exercise in postmenopausal osteoporosis M.I. Cevei a, ⁎, D.C. Stoicanescu b a Faculty of Medicine and Pharmacy, University of Oradea, Oradea, Romania b “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania Abstract: It is estimated that 30–40% of persons over 60 years old have osteoporosis, and about 66% have some degree of osteopenia. Osteoporosis and osteopenia are associated with a risk of fracture as a result of even minimal trauma. The estimated lifetime risk of osteoporotic fracture is as high as 50%. The risk of fracture increases two to three times for every 10% drop in bone mineral density. At menopause, loss of estrogen affects postural stability by slowing down brain processing speed. It was found that 43.3% and 12.6% respectively, of all non-vertebral fractures occurred in women with osteopenia or normal BMD. Bone loss can be prevented by reducing or eliminating modifiable risk factors. The objective of this study was to determine the effects of balance training exercises and weightbearing exercise program on balance, strength and bone mineral density (BMD) in osteopenic and osteoporotic women. 122 women, 84 with osteopenia and 38 with vertebral osteoporosis, aged between 39 and 76 years, mean age 61.24 years, SD 10.2 years, with Tscores ranging from −1.0 to −2.5 and −2.5 to −3 respectively, were recruited from the patients admitted in the Rehabilitation Clinical Hospital from Baile Felix. Training included three fast 30-minute walks and two sessions of one-hour training per week. They followed an exercise program every day for two weeks, then twice a week, for 20 weeks (one-hour exercise sessions with a trained physiotherapist). Assessments at baseline and at the end of this program included balance testing, strength testing (quadriceps, hip adductors/ abductors/external rotators and trunk extensors), and DXA scans (proximal femur and lumbar spine). Evaluation made at the end of the training revealed markedly significant better performances in balance (unilateral and bilateral stance sway measures, lateral reach, timed up and go and step test) (p < 0.05) with strong positive training effects reflecting improvements of between 9% and 69%. Similarly there were gains in strength of the hip muscles (abductors, adductors, and external rotators), quadriceps and trunk extensors with training effects between 7% and 30%. In all cases the total hip BMD increased with a mean of +0.005 g/cm 2 (± 0.017), representing +0.47%.
Abstracts / Bone 48 (2011) S204–S212
e
Early Clin Dev Statistics, MERCK & CO., INC., West Point, USA Modeling and Simulation, MERCK & CO., INC., West Point, USA g Safety Assessment-LAR, MERCK & CO., INC., West Point, USA h Biomedical Engineering, Wright State University, Dayton, OH, USA i Neuroscience, MERCK & CO., INC., West Point, USA j Molecular Endocrinology, MERCK & CO., INC., West Point, USA f
Abstract: This study evaluates the effects of the Cathepsin K inhibitor, odanacatib (ODN) on bone, and compares it to alendronate (ALN) in an osteoporosis prevention mode in the bilateral overiectomized (OVX) rhesus monkey model of estrogen-deficiency. Four imaging modalities were used to monitor bone density and geometrical parameters at baseline, 3, 6, 9, 12, and 18 months in OVX-monkeys (16/group, age 10–22 yrs) treated with vehicle (VEH), ODN (2 mg/kg/d — approx. clinical exposure) or ALN (30 μg/kg/wk). Imaging was performed in the ultradistal (UD) radius, UD tibia, distal radius and distal tibia by HR-pQCT (XtremeCT, Scanco Medical), similar regions by MRI (Siemens TIM Trio), lumbar spine (LS) and proximal femur by QCT (GE-DST), and in standard locations by DXA (GE Lunar iDXA). QCT analysis was performed using Mindways Software modified for non-human primate analysis. HR-pQCT analysis was performed using Scanco's standard method for density and structure, and with expanded versions for direct geometrical measurements and cortical evaluations. An increase in BMD was observed in the clinically relevant locations. Percent increases in BMD compared to VEH at 18 mo (p < 0.001) for ODN and (ALN), (* indicates ODN significantly different from ALN p < 0.05) were: LS aBMD DXA 12.7 (12.6); LS-trabecular vBMD QCT 11.7 (10.5), femoral neck integral vBMD QCT 9.7* (5.6), UD radius aBMD DXA 17.4* (9.1); UD radius integral vBMD HR-pQCT 18.9* (6.9). A striking treatment effect of ODN was an increase in cortical thickness (CtTh) at multiple locations with significant difference from ALN. Percent increases in CtTh compared to VEH at 18 mo (p < 0.001) for ODN and (ALN) were: UD radius HR-pQCT 26.4* (2.8); distal radius HR-pQCT 7.8* (3.6); distal radius MRI 10.6* (4.8); UD tibia HR-pQCT 7.0* (−0.1), distal tibia HR-pQCT 4.5 (1.5), distal tibia MRI 4.1* (0.6), femoral shaft QCT 12.3* (4.4). A significant and steady decrease in endosteal perimeters with ODN treatment suggests bone formation on the endosteal surface. Percent change from baseline at 18 mo for periosteal and endosteal perimeters, respectively for ODN (and ALN) were: UD radius HR-pQCT −0.7 (−0.1), − 7.7* (−1.2); distal radius HR-pQCT 0.5 (0.4), −5.6* (−1.4). In summary, imaging studies have demonstrated that ODN treatment causes a clinically relevant effect in increasing BMD, a robust increase in cortical thickness with significant difference from ALN, and evidence of bone formation on the endosteal surface. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: D. Williams Employee of Merck & Co. Inc., P. McCracken Employee of Merck & Co., Inc. (past); currently Eisai Pharmaceuticals, R. Jayakar Employee of Merck & Co. Inc., M. Purcell Employee of Merck & Co., Inc, P. Mathers Employee of Merck & Co. Inc., A. Savitz Employee of Merck & Co. Inc., J. Szumiloski Employee of Merck & Co. Inc., A. Cabal Employee of Merck & Co. Inc., B. Dardzinski Employee of Merck & Co. Inc., S. Motzel Employee of Merck & Co. Inc., T. Hangartner Consulting fees from Merck & Co. Inc., R. Hargreaves Employee of Merck & Co. Inc., J. Evelhoch Employee of Merck & Co. Inc., L. Duong Employee of Merck & Co. Inc., and J. Cook Employee of Merck & Co. Inc.
doi:10.1016/j.bone.2011.03.468
PP338-M Evaluation of the impact of a case-finding strategy for vertebral fractures on bisphosphonate prescribing in primary care (COSHIBA) E. Clark ⁎, V. Gould, L. Morrison, J. Tobias University of Bristol, Bristol, UK Abstract: Introduction: Patients with vertebral fractures (VFs) are at a high risk of further fractures, have a reduced quality of life and excess mortality. Despite this, only a minority of VFs come to clinical attention. We previously carried out a population-based study to identify risk factors for prevalent VFs that could form the basis for a simple screening tool. To test the utility of this tool, we performed an RCT to determine whether its application in primary care leads to a measurable increase in prescribing of drugs used for prevention of vertebral and other osteoporotic fractures, such as bisphosphonates. Methods: We recruited women from primary care within Bristol, UK (COSHIBA, the Cohort for Skeletal Health in Bristol and Avon). The only eligibility criteria were an age between 65 and 80. Baseline data was collected by selfcompleted questionnaire. Those in the intervention arm received the simple screening tool (reported height loss, history of fracture, Margolis pain score and rib-to-pelvis distance) carried out by a research nurse at their GP practice. If participants were found to be at high risk the research nurse arranged a thoracolumbar X-ray. Results of this X-ray were reported by NHS Consultant Radiologists and the report was sent to the participants GP. Those in the control arm received no additional intervention. Bisphosphonate prescribing at six months was used as the primary outcome. Results: 7080 women were approached out of a total of 8224 eligible and 3200 were recruited (45.2%). 1062 were randomised to the intervention arm. There were no differences between the 2 groups at baseline. Of the 1062 in the intervention arm, 983 were screened (92.6%) and 401 (40.8%) were found to be at high risk and offered an X-ray. At 6 months of follow-up 2446 (76.4%) women were still
in the study. At this time point those in the intervention arm were over 2.5 times more likely to have been prescribed a bisphosphonate since the start of the study compared to those in the control arm (OR 2.58, 95%CI 1.26 to 5.38, P = 0.007). A similar increase was seen when results were analysed for bisphosphonate prescribing at 12 months (OR 2.52, 95%CI 1.19 to 4.05, P = 0.012). Discussion: Six months after our simple screening tool was implemented, we report an increase in bisphosphonate prescribing that was maintained at 12 months. Further analyses are underway to explore the cost effectiveness of this tool in preventing VFs, as a prelude to its wider uptake. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.469
PP339-T Hypoparathyroidism (HP) protects bone mass but is highly associated with lumbar morphometric fracture F.D.A. Pereira ⁎, M.L. Mendonça, M.H. Nogueira-Barbosa, P.C.A. Watanabe, S.R. Teixeira, L.M. Maciel, F.J.A. De Paula Internal Medicine, School of Medicine of Ribeirao Preto, USP, Ribeirao Preto, Brazil Abstract: Objectives: To use different imaging techniques to assess bone mass, bone quality and morphometric vertebral fractures in patients with hypoparathyroidism (HP). Methods: Sixteen women with HP (HPG) and seventeen control women (CG) were evaluated. The following biochemical parameters were determined: calcium, albumin, inorganic phosphorus, alkaline phosphatase, creatinine, parathyroid hormone, 25-OH vitamin D, osteocalcin and IGF-1 in serum, and deoxypyridinoline/creatinine in urine. DXA of L1–L4, femoral neck, total hip, distal 1/3 of the forearm, whole body, and body composition were determined. Vertebral morphometry was performed by measuring the anterior, middle and posterior heights of each vertebra. Morphometric fracture was considered when a difference between height measurements was higher than 20%. Mandibular analysis was performed by measuring the inferior mandibular cortical thickness bilaterally in the region of the mental foramen and of the mandibular angle. Results: Age = 62.3± 8.9 y, weight= 72.6 ± 10.9 kg, height= 1.54 ± 7.87 m, and BMI = 30.3 ± 4.2 kg/m 2 of CG did not differ from those of HPG (age = 58± 6.0 y, weight = 71.7± 13.7 kg, height= 1.58 ±6.4 m and BMI = 28.5 ±55 kg/m 2). Also, there was no significant difference between groups in alkaline phosphatase, 25-OH vitamin D or deoxypyridinoline/creatinine levels. Calcium and osteocalcin levels were significantly lower in HPG. HPG presented bone mineral density similar to that of CG at all sites analyzed (e.g. L1–L4: GH = 1.090 ± 0.3 vs CG = 0.970 ± 0.2 g/cm 2; p = 0.2). HPG had a significantly smaller mandibular cortical thickness at the level of the mental foramen than CG. Regarding vertebral morphometry, the presence of fractures was observed in 11 of HPG subjects (62.5%) and only in 2 of CG subjects (11.7%). Conclusion: The present results indicate that, despite the preservation of bone mass, primary HP seems to be associated with a greater fracture risk, at least at the vertebral level. Mandibular cortical bone seems to be an important site for the assessment of bone involvement in primary HP. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.470
PP340-S Densitometric vertebral fracture assessment using the algorithm-based qualitative method: Baseline fracture predicts incident vertebral fracture at 6-year follow-up L. Ferrar a, ⁎, D. Felsenberg b, C. Roux c, C. Glüer d, R. Eastell a a Bone Biomedical Research Unit, University of Sheffield, Sheffield, UK b Centre of Muscle and Bone Research, Charite-Universitatsmedizin, Berlin, Germany c Centre d'Evaluation des Malades Osseuses, Rene Descartes University, Paris, France d Dept of Diagnostic Radiology, University Hospital Schleswig-Holstein, Kiel, Germany Abstract: Introduction: Baseline vertebral fracture (VF) predicts future fracture. Baseline fracture may be identified by low-radiation densitometric vertebral fracture assessment (VFA). Algorithm-based qualitative (ABQ) diagnosis, which requires evidence of endplate depression to define VF, has not previously been applied in longitudinal VFA. Our aim was to examine the association between ABQ baseline and new (incident) VF identified on VFA. Methods: We evaluated thoraco-lumbar VFA scans obtained by Hologic devices at
Abstracts / Bone 48 (2011) S204–S212 baseline and 6-years in the population-based Osteoporosis and Ultrasound Study (OPUS). We studied 674 women from 3 participating OPUS centres who attended both visits; this sample comprised 73 premenopausal women, aged (at baseline) 21 to 40 years and 601 postmenopausal women aged 55 to 80 years. Scans were evaluated visually by an experienced reader using the ABQ method. Morphometric vertebral measurements were not obtained. Baseline scans were evaluated first (without reference to 6-year scans) to classify women as having (i) ≥ 1 baseline VF (endplate fracture with or without cortical fracture) or (ii) no baseline VF (no endplate fracture and vertebral heights normal or no endplate fracture and ≥ 1 non-fracture short vertebral height). Six-year scans were assessed alongside baseline scans to identify incident VFs. Women were classified as having (i) ≥ 1 incident VF (new VF using same criteria for identification of baseline VF) or (ii) no incident VF. We compared proportions of women with and without baseline VF in the pre- and postmenopausal groups (chi squared test). We calculated the odds ratio (OR) for incident VF in women with baseline VF (logistic regression analysis) and compared within-group characteristics of women with and without VF (2 sample t test). Results: Baseline VF was identified in one premenopausal (1%) and 41 postmenopausal women (7%). Incident VFs were identified in 18 postmenopausal women (3%); there were no incident VFs in premenopausal women. Odds ratios (95% CI) for incident VF in postmenopausal women with baseline VF were as follows: unadjusted OR = 9.31 (2.9, 30.4); OR adjusted for age and BMD = 5.33 (1.41, 20.09). Women with baseline or incident VF were older (P < 0.01) and had lower total hip BMD (P < 0.001) compared to women without VF. Conclusions: Baseline vertebral fracture defined by evidence of endplate depression on VFA is associated with increased risk of incident vertebral fracture in postmenopausal women. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.471
PP341-M Height loss rate as a marker of vitamin D deficiency in men with osteoporosis M. Ignaszak-Szczepaniak a, ⁎, M. Michalak b, J. Dytfeld a, W. Horst-Sikorska a a Department of Family Medicine, Poznan University of Medical Sciences, Poznan, Poland b Department of Computer Science and Statistics, Poznan University of Medical Sciences, Poznan, Poland Abstract: Background: Vertebral fractures often are undiagnosed, while we identify patients with osteoporosis. Their incidences increase with age. Height loss is a frequent manifestation of vertebral fractures and is simple to assess. Vitamin D (VD) has good evidence for fall prevention and reduction of fracture risk. Data are inconclusive for men. The aims of study were: 1. to determine the association between serum 25(OH)D concentration and the degree of height loss, previous fractures and risk of falling in Polish men with osteoporosis and 2. to test the efficacy of vitamin D supplementation in preventing falls. Material and methods: The study group comprised 88 men aged 60–87 years (average age 70 yrs) with BMD T-score at the femoral neck or lumbar spine <−2.5 SD. Collected data included self-reported maximum adult height, measurement of current height, number of falls within last 12 months, previous osteoporotic fractures and VD intake. Vertebral fractures were confirmed by X-ray. We assumed that loss of height over 4 cm may indicate vertebral fracture. Plasma 25(OH)D levels were measured with competitive electro chemiluminescence immunoassay technology (Elecsys, Roche). 25(OH)D < 30 ng/ml was regarded as VD insufficiency. Results: Among 88 men, average height loss was 4.05 cm (ranged 0–14 cm). In 40 men loss of height was >=4 cm that suggests clinically silent vertebral fractures in 60% of patients. Only 15 incidents were symptomatic, confirmed by Xray. 20 men experienced other clinical low energy fractures at different locations and 21 fell at least 1 time. 29% patients took regularly VD (200–800 IU daily). In 98% men 25(OH)D was < 30 ng/ml independently of VD intake. The mean serum level was 19.7 ± 5.35 ng/ml (ranged 4–29), and only 2 patients exceeded required level. 25(OH)D concentration was significantly associated with age (p < 0.001). Elderly men had the lowest 25(OH)D concentration. A loss of height at least 5 cm was significantly associated with low level of VD (p = 0.028). There was no relationship for 4 cm cut off. Low serum 25(OH)D concentration wasn't associated with previous symptomatic fractures or falls. Doses of VD supplementation < 800 IU did not reduce the risk of falling. Conclusions: 1. Height loss of >=5 cm may be an indicator of vitamin D deficiency in men. 2. Vitamin D deficiency had no relation to previous fractures and falls in men. 3. Daily intake of vitamin D < 800 IU does not provide adequate vitamin D status and also may not prevent falls. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: None declared.
doi:10.1016/j.bone.2011.03.472
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PP342-T Comparison of lateral decubitus and supine lateral vertebral fracture assessment (VFA) techniques M.A. Paggiosi ⁎, J. Finigan, N. Peel, R. Eastell, L. Ferrar Sheffield NIHR Bone Biomedical Research Unit, Northern General Hospital, Sheffield, UK Abstract: Variations in VFA image quality may occur when using different lateral imaging techniques and hence impact on the accuracy of vertebral fracture (VF) diagnosis. Pearson (JCD 2006, 9, 3: 295–301) reported no clinically significant difference in image quality when assessing lateral decubitus and supine lateral images acquired using GE devices. Evidence of VFA image comparisons between Hologic devices, however, is limited. Our aims were to 1) calculate the agreement for identification of prevalent VF and 2) compare the number of i) readable vertebrae imaged and ii) vertebrae projected obliquely when using these techniques. We selected women (n = 49, age = 77.1 ± 6.5 years), with (n = 25) and without (n = 24) prevalent VFs, participating in either the Fracture or Corticosteroid (FOCUS) study, or the Osteoporosis and Ultrasound (OPUS) study. All subjects underwent both lateral decubitus and supine lateral imaging of the thoraco-lumbar spine, using a Delphi C and a Discovery A densitometer, respectively. All images were reviewed by an expert reader blinded to patient identity and fracture status. Agreement for VF definition was determined using kappa (κ) on a patient by patient basis. All VFs were defined by evidence of endplate fracture with or without cortical fracture (algorithm-based qualitative approach). Discordance between the number of vertebrae that i) could be visually assessed and ii) were visually assessed but were projected obliquely, was compared for the two techniques using Wilcoxon paired sample tests. P < 0.05 indicated statistical significance. A total of 637 vertebrae (T4–L4) were examined using each imaging technique. There was good agreement (κ = 0.76, 95% CIs for κ = 0.57, 0.94) for identification of VF. A greater number of vertebrae could be visually assessed on lateral decubitus images (623 vertebrae (97.8%) for lateral decubitus versus 589 vertebrae (92.4%) for supine lateral; p = 0.001), however, more vertebrae were projected obliquely (145 vertebrae (23.3%) for lateral decubitus compared to 93 vertebrae (15.8%) for supine lateral; p = 0.002). To conclude, there was good agreement for the identification of patients with VF on lateral decubitus and supine lateral images. Discordance in image quality may occur due to variations in the number of readable and obliquely projected vertebrae. However, there does not appear to be a significant impact on VF diagnosis. These data therefore support the use of either lateral imaging technique in clinical practice. This article is part of a Special Issue entitled ECTS 2011. Disclosure of interest: M. Paggiosi: None declared, J. Finigan: None declared, N. Peel: None declared, R. Eastell Grant/Research Support from Eli Lilly, Sanofi-Aventis, Procter & Gamble Pharmaceuticals, Hoffman-La Roche, Pfizer, Novartis, the National Institute for Health Research, and L. Ferrar: None declared. doi:10.1016/j.bone.2011.03.473
PP343-S Beneficial effects of exercise in postmenopausal osteoporosis M.I. Cevei a, ⁎, D.C. Stoicanescu b a Faculty of Medicine and Pharmacy, University of Oradea, Oradea, Romania b “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania Abstract: It is estimated that 30–40% of persons over 60 years old have osteoporosis, and about 66% have some degree of osteopenia. Osteoporosis and osteopenia are associated with a risk of fracture as a result of even minimal trauma. The estimated lifetime risk of osteoporotic fracture is as high as 50%. The risk of fracture increases two to three times for every 10% drop in bone mineral density. At menopause, loss of estrogen affects postural stability by slowing down brain processing speed. It was found that 43.3% and 12.6% respectively, of all non-vertebral fractures occurred in women with osteopenia or normal BMD. Bone loss can be prevented by reducing or eliminating modifiable risk factors. The objective of this study was to determine the effects of balance training exercises and weightbearing exercise program on balance, strength and bone mineral density (BMD) in osteopenic and osteoporotic women. 122 women, 84 with osteopenia and 38 with vertebral osteoporosis, aged between 39 and 76 years, mean age 61.24 years, SD 10.2 years, with Tscores ranging from −1.0 to −2.5 and −2.5 to −3 respectively, were recruited from the patients admitted in the Rehabilitation Clinical Hospital from Baile Felix. Training included three fast 30-minute walks and two sessions of one-hour training per week. They followed an exercise program every day for two weeks, then twice a week, for 20 weeks (one-hour exercise sessions with a trained physiotherapist). Assessments at baseline and at the end of this program included balance testing, strength testing (quadriceps, hip adductors/ abductors/external rotators and trunk extensors), and DXA scans (proximal femur and lumbar spine). Evaluation made at the end of the training revealed markedly significant better performances in balance (unilateral and bilateral stance sway measures, lateral reach, timed up and go and step test) (p < 0.05) with strong positive training effects reflecting improvements of between 9% and 69%. Similarly there were gains in strength of the hip muscles (abductors, adductors, and external rotators), quadriceps and trunk extensors with training effects between 7% and 30%. In all cases the total hip BMD increased with a mean of +0.005 g/cm 2 (± 0.017), representing +0.47%.