BACKGROUND AND OBJECTIVE:To detect FRAX(®) threshold levels that identify groups of the population that are at high/low risk of osteoporotic fracture in the Spanish female population using a cost-effective assessment. PATIENTS AND METHODS:This is a cohort study. Eight hundred and sixteen women 40-90 years old selected from the FRIDEX cohort with densitometry and risk factors for fracture at baseline who received no treatment for osteoporosis during the 10 year follow-up period and were stratified into 3 groups/levels of fracture risk (low<10%, 10-20% intermediate and high>20%) according to the real fracture incidence. RESULTS:The thresholds of FRAX(®) baseline for major osteoporotic fracture were: low risk<5; intermediate ≥ 5 to <7.5 and high ≥ 7.5. The incidence of fracture with these values was: low risk (3.6%; 95% CI 2.2-5.9), intermediate risk (13.7%; 95% CI 7.1-24.2) and high risk (21.4%; 95% CI12.9-33.2). The most cost-effective option was to refer to dual energy X-ray absorptiometry (DXA-scan) for FRAX(®)≥ 5 (Intermediate and high risk) to reclassify by FRAX(®) with DXA-scan at high/low risk. These thresholds select 17.5% of women for DXA-scan and 10% for treatment. With these thresholds of FRAX(®), compared with the strategy of opportunistic case finding isolated risk factors, would improve the predictive parameters and reduce 82.5% the DXA-scan, 35.4% osteoporosis prescriptions and 28.7% cost to detect the same number of women who suffer fractures. CONCLUSIONS:The use of FRAX ® thresholds identified as high/low risk of osteoporotic fracture in this calibration (FRIDEX model) improve predictive parameters in Spanish women and in a more cost-effective than the traditional model based on the T-score ≤ -2.5 of DXA scan.

A les societats occidentals, les fractures per fragilitat augmenten en numeros absoluts associades a l’augment de l’esperanca de vida. L’OMS va publicar el 2008 una eina per tal d’identificar adequadament la poblacio de major risc de fractura per fragilitat i prioritzar accions preventives sobre els col·lectius mes fragils. Aquesta tesi doctoral proposa un calibratge d’aquesta eina per a la poblacio femenina espanyola que permetria reduir les proves realitzades i els tractaments farmacologics i, per tant, la despesa sanitaria.

Background and objective: To detect FRAX (R) threshold levels that identify groups of the population that are at high/low risk of osteoporotic fracture in the Spanish female population using a cost-effective assessment.Patients and methods: This is a cohort study. Eight hundred and sixteen women 40-90 years old selected from the FRIDEX cohort with densitometry and risk factors for fracture at baseline who received no treatment for osteoporosis during the 10 year follow-up period and were stratified into 3 groups/levels of fracture risk (low < 10%, 10-20% intermediate and high > 20%) according to the real fracture incidence.Results: The thresholds of FRAX (R) baseline for major osteoporotic fracture were: low risk <5; intermediate >= 5 to <7.5 and high >= 7.5. The incidence of fracture with these values was: low risk (3.6%; 95% CI 2.2-5.9), intermediate risk (13.7%; 95% CI 7.1-24.2) and high risk (21.4%; 95% CI12.9-33.2). The most cost-effective option was to refer to dual energy X-ray absorptiometry (DXA-scan) for FRAX (R) >= 5 (Intermediate and high risk) to reclassify by FRAX (R) with DXA-scan at high/low risk. These thresholds select 17.5% of women for DXA-scan and 10% for treatment. With these thresholds of FRAX (R), compared with the strategy of opportunistic case finding isolated risk factors, would improve the predictive parameters and reduce 82.5% the DXA-scan, 35.4% osteoporosis prescriptions and 28.7% cost to detect the same number of women who suffer fractures.Conclusions: The use of FRAX (R) thresholds identified as high/low risk of osteoporotic fracture in this calibration (FRIDEX model) improve predictive parameters in Spanish women and in a more cost-effective than the traditional model based on the T-score <= -2.5 of DXA scan. (C) 2013 Elsevier Espana, S.L.U. All rights reserved.

Rafael AZAGRA (Rafael.Azagra@uab.cat) Genis ROCA (groca@movistar.es) Gloria ENCABO (gencabo@vhebron.net) Amada AGUYE (amyaguye@telefonica.net) Marta ZWART (martaifelix@hotmail.com) Silvia GÜELL (24965sgp@comb.cat) Nuria PUCHOL (39434npr@comb.cat) Emili GENE (29833egt@comb.cat) Enrique CASADO (quique.casado@gmail.com) Pilar SANCHO (sanchomp@gmail.com) Silvia SOLÀ (ssolamun@yahoo.es) Pere TORÁN (ptoran.bnm.ics@gencat.cat) Milagros IGLESIAS (milaiglesias@camfic.org) M Carmen GISBERT (mariacarmengisbert@gencat.cat) Francesc LÓPEZ-EXPÓSITO (flopeze@papps.org) Yolanda FERNÁNDEZ (yolafern@yahoo.es) Ana PUENTE (20892aps@comb.cat) Mireia ROSÀS (mireiarosas@gmail.com) Vicente BOU (vbou@gencat.cat) Juan José ANTÓN (bilbojuanjo@hotmail.es) Gustavo LANSDBERG (gustavolandsberg@gmail.com) Juan Carlos MARTÍN-SÁNCHEZ (juancarlosmarsan@gmail.com) Liz I ABADO (liarcv97@gmail.com) Adolf DÍEZ-PÉREZ (ADiez@imas.imim.es) Jesús PUJOL-SALUD (jpujols@medynet.com)

BACKGROUND:Age-related bone loss is asymptomatic, and the morbidity of osteoporosis is secondary to the fractures that occur. Common sites of fracture include the spine, hip, forearm and proximal humerus. Fractures at the hip incur the greatest morbidity and mortality and give rise to the highest direct costs for health services. Their incidence increases exponentially with age.Independently changes in population demography, the age - and sex- specific incidence of osteoporotic fractures appears to be increasing in developing and developed countries. This could mean more than double the expected burden of osteoporotic fractures in the next 50 years.METHODS/DESIGN:To assess the predictive power of the WHO FRAX™ tool to identify the subjects with the highest absolute risk of fragility fracture at 10 years in a Spanish population, a predictive validation study of the tool will be carried out. For this purpose, the participants recruited by 1999 will be assessed. These were referred to scan-DXA Department from primary healthcare centres, non hospital and hospital consultations.STUDY POPULATION:Patients attended in the national health services integrated into a FRIDEX cohort with at least one Dual-energy X-ray absorptiometry (DXA) measurement and one extensive questionnaire related to fracture risk factors.MEASUREMENTS:At baseline bone mineral density measurement using DXA, clinical fracture risk factors questionnaire, dietary calcium intake assessment, history of previous fractures, and related drugs. Follow up by telephone interview to know fragility fractures in the 10 years with verification in electronic medical records and also to know the number of falls in the last year. The absolute risk of fracture will be estimated using the FRAX™ tool from the official web site.DISCUSSION:Since more than 10 years ago numerous publications have recognised the importance of other risk factors for new osteoporotic fractures in addition to low BMD. The extension of a method for calculating the risk (probability) of fractures using the FRAX™ tool is foreseeable in Spain and this would justify a study such as this to allow the necessary adjustments in calibration of the parameters included in the logarithmic formula constituted by FRAX™.

Estudiar la prevalencia de osteoporosis y probabilidad de fractura en pacientes diagnosticados de cáncer de próstata.Estudio observacional, descriptivo y transversal.Estudio realizado desde atención primaria del área sanitaria de Lugo en colaboración con los servicios de Reumatología y Urología de nuestro hospital de referencia.Pacientes diagnosticados de cáncer de próstata sin enfermedad metastásica ósea, desde enero a diciembre del año 2012.Se recogieron variables epidemiológicas, clínicas, analíticas y densitométricas implicadas en la osteoporosis. Se estimó la probabilidad de fractura mediante la herramienta FRAX®.Ochenta y tres pacientes cumplieron los criterios de inclusión. Ninguno fue excluido. La edad media fue de 67 años. El índice de masa corporal fue de 28,28. Veinticinco pacientes (30,1%) presentaban fracturas osteoporóticas previas. Otros factores de riesgo prevalentes fueron el alcohol (26,5%) y el tabaco (22,9%). Ochenta y dos sujetos presentaban valores de vitamina D por debajo de lo normal (98,80%). La densitometría de cuello femoral mostró que el 8,9% presentaron osteoporosis y el 54% osteopenia.La media del riesgo de fractura en esta población, estimado con la herramienta FRAX®, fue del 2,63% para fractura de cuello femoral y del 5,28% para fractura principal.Utilizando los puntos de corte para el riesgo de fractura propuestos por Azagra et al., 24 pacientes (28,92%) tuvieron un valor de FRAX® para fractura principal sin DXA de más del 5%, y 8 sujetos (9,64%), ≥ 7,5%.La prevalencia de osteoporosis en esta población fue muy elevada.Los factores de riesgo asociados a osteoporosis más frecuentes fueron: fractura osteoporótica previa, consumo de alcohol, hábito tabáquico y antecedente familiar de fractura previa.La probabilidad de fractura mediante la herramienta FRAX® de cuello femoral fue baja.La hipovitaminosis D fue muy frecuente (98,8%).To study the prevalence of osteoporosis and fracture probability in patients diagnosed with prostate cancer.Observational descriptive transversal study.Study performed from Primary Care of Lugo in collaboration with Rheumatology and Urology Services of our referral hospital.Patients diagnosed with prostate cancer without bone metastatic disease from January to December 2012.Epidemiologic, clinical, laboratory and densitometric variables involved in osteoporosis were collected. The likelihood of fracture was estimated by FRAX® Tool.Eighty-three patients met the inclusion criteria. None was excluded. The average age was 67 years. The Body Mass Index was 28.28. Twenty-five patients (30.1%) had previous osteoporotic fractures. Other prevalent risk factors were alcohol (26.5%) and smoking (22.9%). Eighty-two subjects had vitamin D below normal level (98.80%). Femoral Neck densitometry showed that 8.9% had osteoporosis and 54% osteopenia.The average fracture risk in this population, estimated by FRAX®, was 2.63% for hip fracture and 5.28% for major fracture.Cut level for FRAX® major fracture value without DXA > 5% and ≥ 7.5% proposed by Azagra et al. showed 24 patients (28.92%) and 8 patients (9.64%) respectively.The prevalence of osteoporosis in this population was very high.The more frequent risk factors associated with osteoporosis were: previous osteoporotic fracture, alcohol consumption, smoking and family history of previous fracture.The probability of fracture using femoral neck FRAX® tool was low.Vitamin D deficiency was very common (98.8%).

BACKGROUND:Osteoporosis is a serious health problem that worsens the quality of life and the survival rate of individuals with this disease on account the osteoporotic fractures. Studies have long focused on women, and its presence in men has been underestimated. While many studies conducted in different countries mainly assess health-related quality of life and identify fracture risks factors in women, few data are available on a Spanish male population.METHODS/DESIGN:Observational study.STUDY POPULATION:Men ≥ 40 years of age with/without diagnosed osteoporosis and with/without osteoporotic fracture included by their family doctor.MEASUREMENTS:The relationship between customary clinical risk factors for osteoporotic fracture and health-related quality of life in a Spanish male population. A telephone questionnaire on health-related quality of life is made.STATISTICAL ANALYSIS:The association between qualitative variables will be assessed by the Chi-square test. The distribution of quantitative variables by Student's t-test. If the conditions for using this test are not met, the non-parametric Mann-Whitney's U test will be used.The validation of the results obtained by the FRAX™ tool will be performed by way of the Hosmer-Lemeshow test and by calculating the area under the Receiver Operating Characteristic (ROC) curve (AUC). All tests will be performed with a confidence intervals set at 95%.DISCUSSION:The applicability and usefulness of Health-related quality of life (HRQOL) studies are well documented in many countries. These studies allow implementing cost-effective measures in cases of a given disease and reducing the costly consequences derived therefrom. This study attempts to provide objective data on how quality of life is affected by the clinical aspects involved in osteoporosis in a Spanish male population and can be useful as well in cost utility analyses conducted by health authorities.The sample selected is not based on a high fracture risk group. Rather, it is composed of men in the general population, and accordingly comparisons should not lead to erroneous interpretations.A possible bias correction will be ensured by checking reported fractures against healthcare reports and X-rays, or by consulting health care centers as applicable.