Adolfo Díez-Pérez

Autonomous University of Barcelona, Cerdanyola del Vallès, Catalonia, Spain

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Publications (171)704.46 Total impact

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    ABSTRACT: To determine the association between socio-economic status (SES) and risk of hand, hip or knee osteoarthritis at a population level. Retrospective ecological study using the SIDIAP database (primary care anonymized records for > 5 million people in Catalonia (Spain)). Urban residents > 15 years old (2009-2012) were eligible. Validated area-based SES deprivation index MEDEA (proportion of unemployed, temporary workers, manual workers, low educational attainment and low educational attainment among youngsters) was estimated for each area based on census data as well as incident diagnoses (ICD-10 codes) of hand, hip or knee osteoarthritis (2009-2012). Zero-inflated Poisson models were fitted to study the association between MEDEA quintiles and the outcomes. Compared to the least deprived, the most deprived areas were younger (43.29 (17.59) versus 46.83 (18.49), years (Mean SD), had fewer women (49.1% versus 54.8 %), a higher percentage of obese (16.2 % versus 8.4 %), smokers (16.9 % versus 11.9%) and high-risk alcohol consumption subjects (1.5% versus 1.3 %). Compared to the least deprived, the most deprived areas had an excess risk of osteoarthritis: age-sex-adjusted IRR 1.26 (1.11-1.42) for hand, 1.23 (1.17-1.29) hip, and 1.51 (1.45-1.57) knee. Adjustment for obesity attenuated this association: 1.06 (0.93 -1.20), 1.04 (0.99-1.09), and 1.23 (1.19-1.28) respectively. Deprived areas have higher rates osteoarthritis (hand, hip, knee). Their increased prevalence of obesity accounts for a 50% of the excess risk of knee osteoarthritis observed. Public health interventions to reduce the prevalence of obesity in this population could reduce health inequalities. Copyright © 2015. Published by Elsevier Ltd.
    Osteoarthritis and Cartilage 03/2015; DOI:10.1016/j.joca.2015.03.020 · 4.66 Impact Factor
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    ABSTRACT: Glucocorticoids, widely used in inflammatory disorders, rapidly increase bone fragility and, therefore, fracture risk. However, common bone densitometry measurements are not sensitive enough to detect these changes. Moreover, densitometry only partially recognizes treatment-induced fracture reductions in osteoporosis. Here, we tested whether the reference point indentation, technique could detect bone tissue properties changes early after glucocorticoid treatment initiation. After initial laboratory and bone density measurements, patients were allocated into groups receiving calcium + vitamin D (Ca + D) supplements or anti-osteoporotic drugs (risedronate, denosumab, teriparatide). Reference point indentation was performed on the cortical bone layer of the tibia by a handheld device measuring Bone Material Strength index (BMSi). Bone mineral density was measured by dual-energy x-ray absorptiometry (DXA). While Ca + D-treated patients exhibited substantial and significant deterioration, risedronate-treated patients exhibited no significant change, and both denosumab- and teriparatide-treated participants exhibited significantly improved BMSi 7 weeks after initial treatment compared to baseline; these trends remained stable for 20 weeks. In contrast, no densitometry changes were observed during this study period. In conclusion, our study is the first to demonstrate that reference point indentation is sensitive enough to reflect changes in cortical bone indentation following treatment with osteoporosis therapies in patients newly exposed to glucocorticoids. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 03/2015; DOI:10.1002/jbmr.2497 · 6.59 Impact Factor
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    ABSTRACT: Many studies have shown a correlation between chronic kidney disease (CKD) and fracture. However, an increased mortality in CKD patients is a competing risk scenario, not accounted for in previously. Our aim was to investigate the true impact of CKD on hip fracture after accounting for a competing risk with death. We conducted a population-based cohort study to determine the impact of CKD on hip fractures in individuals aged ≥50years old registered in SIDIAP(Q) database (representative 1.9 million people in Catalonia, Spain). Cox regression was used to estimate Hazard Ratio (HR) for death and hip fracture according to CKD status. A competing risk (Fine and Gray) model was fitted to estimate sub-HR for hip fracture in CKD or CKD-free patients accounting for differential mortality. 873,073 (32,934 (3.8%) CKD) patients were observed for 3years. 4,823 (14.6%) CKD and 36,328 (4.3%) CKD-free participants died during follow-up (HR 1.83 [95%CI 1.78-1.89]), whilst 522 (1.59%) and 6,292 (0.75%) sustained a hip fracture respectively. Adjusted Cox models showed a significantly increased risk of hip fractures for CKD group (HR 1.16 [1.06-1.27]), but this association was attenuated in competing risk models accounting for mortality (SHR 1.14 [1.03-1.27]). Both death and hip fracture rates are increased (by 83% and 16% respectively) in CKD patients. However, the association between CKD and hip fractures is attenuated when an excess mortality is taken into account. A competing risk with death must be considered in future analyses of association between CKD and any health outcomes. Copyright © 2014. Published by Elsevier Inc.
    Bone 12/2014; 73. DOI:10.1016/j.bone.2014.12.020 · 4.46 Impact Factor
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    ABSTRACT: To determine the association between socio-economic deprivation (SES) and hip fracture risk. Retrospective cohort study using a population-based database (primary care records) of over 5 million people. Eligibility: all living subjects registered during the period 2009-2012 and resident in an urban area. Measures: a validated SES composite index (proportion of unemployed, temporary workers, manual workers, low educational attainment and low educational attainment among youngsters) estimated for each area based on census data. Outcome: incident hip fracture rates as coded in medical records using ICD-10 codes. Statistics: zero-inflated Poisson models fitted to study the association between SES quintiles and hip fracture risk, adjusted for age, sex, obesity, smoking and alcohol consumption. Compared to the most deprived, wealthy areas had a higher hip fracture incidence (age-sex adjusted incidence 38.57 (37.14-40.00) compared to 34.33 (32.90-35.76) per 10,000 person-years). Similarly, most deprived areas had a crude and age-sex adjusted lower risk of hip fracture, RR of 0.71 (0.65-0.78) and RR of 0.90 (0.85-0.95) respectively compared to wealthiest areas. The association was attenuated and no longer significant after adjustment for obesity: RR 0.96 (0.90-1.01). Further adjustment for smoking and high alcohol consumption did not make a difference. Wealthiest areas have an almost 30% increased risk of hip fracture compared to the most deprived. Differences in age-sex composition and a higher prevalence of obesity in deprived areas could explain this higher risk. Copyright © 2014. Published by Elsevier Inc.
    Bone 12/2014; 73. DOI:10.1016/j.bone.2014.12.019 · 4.46 Impact Factor
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    ABSTRACT: Context. Several fracture prediction models that combine fractures at different sites into a composite outcome are in current use. However, to the extent individual fracture sites have differing risk factor profiles, model discrimination is impaired. Objective. To improve model discrimination by developing a 5-yr composite fracture prediction model for fracture sites that display similar risk profiles. Design. Prospective, observational cohort study. Setting. Primary care practices in 10 countries. Patients. Women aged ≥55 years. Intervention. Self-administered questionnaires collected data on patient characteristics, fracture risk factors and previous fractures. Main Outcome Measure. Main outcome is time to first clinical fracture of hip, pelvis, upper leg, clavicle, or spine, each of which exhibits a strong association with advanced age. Results. Of four composite fracture models considered, model discrimination (c index) is highest for an age-related fracture model (c index 0.75, 47,066 women), and lowest for FRAX major fracture and a 10-site model (c indices 0.67 and 0.65). The unadjusted increase in fracture risk for an additional 10 yr of age ranges from 80% to 180% for the individual bones in the age-associated model. Five other fracture sites not considered for the age-associated model (upper arm/shoulder, rib, wrist, lower leg, and ankle) have age associations for an additional 10 yr of age from a 10% decrease to a 60% increase. Conclusions. After examining results for 10 different bone fracture sites, advanced age appeared the single best possibility for uniting several different sites, resulting in an empirically based composite fracture risk model.
    The Journal of Clinical Endocrinology and Metabolism 12/2014; 99(3):jc20133468. DOI:10.1210/jc.2013-3468 · 6.31 Impact Factor
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    ABSTRACT: Summary There is scarce data on the association between early stages of type 2 diabetes and fracture risk. We report a 20 % excess risk of hip fracture in the first years following disease onset compared to matched non-diabetic patients. Introduction Type 2 diabetes mellitus (T2DM) is a chronic disease that affects several target organs. Data on the association between T2DM and osteoporotic fractures is controversial. We estimated risk of hip fracture in newly diagnosed T2DM patients, compared to matched non-diabetic peers. Methods We conducted a population-based parallel cohort study using data from the Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) database. Participants were all newly diagnosed T2DM patients registered in SIDIAP in 2006–2011 (T2DM cohort). Up to two diabetes-free controls were matched to each T2DM participant on age, gender, and primary care practice. Main outcome was incident hip fracture in 2006–2011, ascertained using the tenth edition of the International Classification of Diseases (ICD-10) codes. We used Fine and Gray survival modelling to estimate risk of hip fracture according to T2DM status, accounting for competing risk of death. Multivariate models were adjusted for body mass index, previous fracture, and use of oral corticosteroids. Results During the study period (median follow-up 2.63 years), 444/58,483 diabetic patients sustained a hip fracture (incidence rate 2.7/1,000 person-years) compared to 776/113,448 matched controls (2.4/1,000). This is equivalent to an unadjusted (age- and gender-matched) subhazard ratio (SHR) 1.11 [0.99–1.24], and adjusted SHR 1.20 [1.06–1.35]. The adjusted SHR for major osteoporotic and any osteoporotic fractures were 0.95 [0.89–1.01] and 0.97 [0.92–1.02]. Conclusions Newly diagnosed T2DM patients are at a 20 % increased risk of hip fracture even in early stages of disease, but no for all fractures. More data is needed on the causes for an increased fracture risk in T2DM patients as well as on the predictors of osteoporotic fractures among these patients.
    Osteoporosis International 12/2014; 26(2). DOI:10.1007/s00198-014-2986-9 · 4.17 Impact Factor
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    ABSTRACT: Osteoporosis is commonly associated with menopause and ageing. It can, however, also be caused by diseases, lifestyle, genetic diseases, drug therapies and other therapeutic interventions. In cases of secondary osteoporosis, a common rule is the management of the underlying condition. Healthy habits and calcium and vitamin D supplementation are also generally advised. In cases of high risk of fracture, specific antiosteoporosis medications should be prescribed. For most conditions, the available evidence is limited. Special attention should be paid to possible contraindications of drugs used for the treatment of postmenopausal or senile osteoporosis. Bisphosphonates are the most widely used drugs in secondary osteoporosis, and denosumab or teriparatide have been also assessed in some cases. Important research is needed to develop more tailored strategies, specific to the peculiarities of the different types of secondary osteoporosis.
    Best Practice & Research: Clinical Endocrinology & Metabolism 12/2014; DOI:10.1016/j.beem.2014.09.004 · 4.91 Impact Factor
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    ABSTRACT: From 50 years of age, postmenopausal women are at an increased risk of developing sarcopenia and osteoporosis as a result of deterioration of musculoskeletal health. Both disorders increase the risk of falls and fractures. The risk of developing sarcopenia and osteoporosis may be attenuated through healthy lifestyle changes, which include adequate dietary protein, calcium and vitamin D intakes, and regular physical activity/exercise, besides hormone replacement therapy when appropriate. Protein intake and physical activity are the main anabolic stimuli for muscle protein synthesis. Exercise training leads to increased muscle mass and strength, and the combination of optimal protein intake and exercise produces a greater degree of muscle protein accretion than either intervention alone. Similarly, adequate dietary protein intake and resistance exercise are important contributors to the maintenance of bone strength. Vitamin D helps to maintain muscle mass and strength as well as bone health. These findings suggest that healthy lifestyle measures in women aged >50 years are essential to allow healthy aging. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommends optimal dietary protein intake of 1.0–1.2 g/kg body weight/d with at least 20–25 g of high-quality protein at each main meal, with adequate vitamin D intake at 800 IU/d to maintain serum 25-hydroxyvitamin D levels >50 nmol/L as well as calcium intake of 1000 mg/d, alongside regular physical activity/exercise 3–5 times/week combined with protein intake in close proximity to exercise, in postmenopausal women for prevention of age-related deterioration of musculoskeletal health.
    Maturitas 11/2014; 79(1). DOI:10.1016/j.maturitas.2014.07.005 · 2.86 Impact Factor
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    ABSTRACT: Ankylosing spondylitis (AS) leads to osteopenia/osteoporosis and spine rigidity. We conducted a case-control study and found that AS-affected patients have a 5-fold and 50 % increased risk of clinical spine and all clinical fractures, respectively. Excess risk of both is highest in the first years and warrants an early bone health assessment after diagnosis.
    Osteoporosis International 10/2014; 26(1). DOI:10.1007/s00198-014-2939-3 · 4.17 Impact Factor
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    ABSTRACT: Objective. Patients with OA use different drugs in their search for relief. We aimed to study the prevalence of use and combinations of different medications for OA in a population-based cohort of OA patients in Catalonia, Spain, while characterizing users of each of the drugs available, with a particular focus on cardiovascular risk factors. Methods. Data were obtained from the Sistema d‘Informació per al Desenvolupament de l‘Investigació en Atenció Primària (SIDIAP) database, which includes electronic medical records and pharmacy invoice data for >5 million people from Catalonia. Study participants were those with a clinical diagnosis of OA in 2006-10. Drugs studied included oral and topical NSAIDs, analgesics (paracetamol, metamizole), opioids (tramadol, fentanyl), cyclooxygenase 2 (COX-2) inhibitors and symptomatic slow-acting drugs in OA. Drug utilization was described using medication possession ratios (MPRs), equivalent to the proportion of days covered with the drug of interest. The annual incidence of new users in the first year after OA diagnosis from 2006 to 2010 was estimated for all studied drugs among newly diagnosed OA patients using Poisson regression. Results. We identified 238 536 study participants. The most common regimen of treatment consisted of at least three drugs (53.9% of patients). The drugs most frequently used regularly (MPR ≥50%) were chondroitin (21.2%), glucosamine (15.8%) and oral NSAIDs (14.4%). The incidence of the use of opioids, COX-2 inhibitors and chondroitin increased over the 5 year period, whereas all others decreased. Conclusion. Drug combinations are common in the treatment of OA patients, who are thus exposed to potential drug interactions, with unknown impacts on their health. The increasing use of opioids and COX-2 inhibitors is noteworthy because of the potential impact on safety and costs.
    Rheumatology (Oxford, England) 10/2014; 54(5). DOI:10.1093/rheumatology/keu403 · 4.44 Impact Factor
  • Osteoporosis International 09/2014; 26(1). DOI:10.1007/s00198-014-2883-2 · 4.17 Impact Factor
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    ABSTRACT: Fractures in obese older individuals contribute significantly to the overall burden, but data on their impact on mortality are lacking. We studied the association between obesity and mortality following hip and non-hip clinical fractures in a retrospective, population-based cohort study. The SIDIAP(Q) database contains primary care computerized medical records of a representative sample of >2.1 million people (35% of the population) in Catalonia (Spain), linked to hospital admissions data. We included in this analysis anyone aged 40 years and older suffering a hip or non-hip clinical fracture in 2007-2009 in the SIDIAP(Q) database. The main exposure was the most recent body mass index (BMI) measured before fracture, categorized as underweight (<18.5 kg/m(2) ), normal (18.5 to <25 kg/m(2) ), overweight (25 to <30 kg/m(2) ) and obese (≥30 kg/m(2) ). Furthermore, the study outcome was all-cause mortality in 2007-2009 as provided to SIDIAP(Q) by the National Office of Statistics. Time to death after fracture was modelled using Cox regression. Multivariate models were adjusted for age, gender, smoking, alcohol intake, oral glucocorticoid use, and Charlson co-morbidity Index. Within the study period, 6,988 and 29,372 subjects with a hip or non-hip clinical fracture were identified and followed for a median (inter-quartile range) of 1.17(0.53-2.02) and 1.36(0.65-2.15) years, respectively. Compared to subjects of normal weight, adjusted hazard ratios (HR) for mortality in overweight and obese subjects were 0.74 (95%CI 0.62-0.88; p = 0.001) and 0.74 (0.60-0.91; p = 0.004) after hip and 0.50 (0.32-0.77; p = 0.002), 0.56 (0.36-0.87; p = 0.010) after non-hip fracture. In conclusion, the highest mortality was observed in individuals with low BMI, but compared to subjects of normal weight, obese and overweight individuals survived longer following fracture. The latter observation is consistent with data reported in other chronic conditions, but the reasons for reduced mortality in obese and overweight subjects when compared to those of normal weight require further research. © 2014 American Society for Bone and Mineral Research.
    Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 08/2014; 29(8). DOI:10.1002/jbmr.2209 · 6.59 Impact Factor
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    ABSTRACT: This consensus article reviews the diagnosis and treatment of osteoporosis in geriatric populations. Specifically, it reviews the risk assessment and intervention thresholds, the impact of nutritional deficiencies, fall prevention strategies, pharmacological treatments and their safety considerations, the risks of sub-optimal treatment adherence and strategies for its improvement. This consensus article reviews the therapeutic strategies and management options for the treatment of osteoporosis of the oldest old. This vulnerable segment (persons over 80 years of age) stands to gain substantially from effective anti-osteoporosis treatment, but the under-prescription of these treatments is frequent. This report is the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores some of the reasons for this and presents the arguments to counter these beliefs. The risk assessment of older individuals is briefly reviewed along with the differences between some intervention guidelines. The current evidence on the impact of nutritional deficiencies (i.e. calcium, protein and vitamin D) is presented, as are strategies to prevent falls. One possible reason for the under-prescription of pharmacological treatments for osteoporosis in the oldest old is the perception that anti-fracture efficacy requires long-term treatment. However, a review of the data shows convincing anti-fracture efficacy already by 12 months. The safety profiles of these pharmacological agents are generally satisfactory in this patient segment provided a few precautions are followed. These patients should be considered for particular consultation/follow-up procedures in the effort to convince on the benefits of treatment and to allay fears of adverse drug reactions, since poor adherence is a major problem for the success of a strategy for osteoporosis and limits cost-effectiveness.
    Osteoporosis International 07/2014; 25(11). DOI:10.1007/s00198-014-2755-9 · 4.17 Impact Factor
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    ABSTRACT: Hydroxyapatite (HAp)-TiO2 samples obtained using high velocity oxy-fuel spray (HVOF), that had previously shown excellent mechanical behaviour, were innovatively surface treated in order to improve their biological performance. The chosen treatments were an alkaline treatment to increase -OH radicals density on the surface (especially on TiO(2)zones), and a collagen treatment to bond collagen fibrils to the -OH radicals present in hydroxyapatite. These coatings were analysed using scanning electron microscopy, energy-dispersive X-ray spectroscopy and infrared spectroscopy, and tested for human osteoblast biocompatibility and functionality. In the case of the alkaline treatment, although the -OH radicals density did not increase compared to the as-sprayed coatings, a nanostructured layer of sodium hydroxycarbonate precipitated on the surface, thus improving biological behaviour due to the nanoroughness effect. For the collagen-treated samples, collagen fibrils appeared well-adhered to the surface, and in vitro cell culture tests showed that these surfaces were much more conducive to cell adhesion and differentiation than the as-sprayed and alkaline-treated samples. These results pointed to collagen treatment as a very promising method to improve bioactivity of HAp-TiO2 thermal-sprayed coatings.
    Applied Surface Science 07/2014; 307:246–254. DOI:10.1016/j.apsusc.2014.04.021 · 2.54 Impact Factor
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    ABSTRACT: With the advent of high active antiretroviral therapy there was a significant improvement on HIV subjects survival. Thus, bone changes related to HIV became an important aspect of these individuals. HIV affects bone remodeling causing bone fragility. In addition, antiretroviral therapy may also negatively affect bone metabolism. Several studies describe an increased incidence of fractures in these patients when compared with controls without the disease. The European Society of AIDS (EACS), and other societies, have included guidance on management of osteoporosis in HIV-infected patients emphasizing the identification of patients with low bone mass. Supplementation of calcium and vitamin D and the use of alendronate in these individuals should be recommended on a case base.
    Arquivos Brasileiros de Endocrinologia & Metabologia 07/2014; 58(5):478-483. DOI:10.1590/0004-2730000003323 · 0.68 Impact Factor
  • Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):1073-1073. DOI:10.1136/annrheumdis-2014-eular.4055 · 9.27 Impact Factor
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    ABSTRACT: The aims of the study were to establish the prevalence of high bone mass (HBM) in a cohort of Spanish postmenopausal women (BARCOS) and to assess the contribution of LRP5 and DKK1 mutations and of common bone mineral density (BMD) variants to a HBM phenotype. Furthermore, we describe the expression of several osteoblast-specific and Wnt-pathway genes in primary osteoblasts from two HBM cases. A 0.6% of individuals (10/1600) displayed Z-scores in the HBM range (sum Z-score >4). While no mutation in the relevant exons of LRP5 was detected, a rare missense change in DKK1 was found (p.Y74F), which cosegregated with the phenotype in a small pedigree. Fifty-five BMD SNPs from Estrada et al. [NatGenet 44:491-501,2012] were genotyped in the HBM cases to obtain risk scores for each individual. In this small group of samples, Z-scores were found inversely related to risk scores, suggestive of a polygenic etiology. There was a single exception, which may be explained by a rare penetrant genetic variant, counterbalancing the additive effect of the risk alleles. The expression analysis in primary osteoblasts from two HBM cases and five controls suggested that IL6R, DLX3, TWIST1 and PPARG are negatively related to Z-score. One HBM case presented with high levels of RUNX2, while the other displayed very low SOX6. In conclusion, we provide evidence of lack of LRP5 mutations and of a putative HBM-causing mutation in DKK1. Additionally, we present SNP genotyping and expression results that suggest additive effects of several genes for HBM.
    PLoS ONE 04/2014; 9(4):e94607. DOI:10.1371/journal.pone.0094607 · 3.53 Impact Factor
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    ABSTRACT: We used a large population-based health care database to determine the impact of common co-morbidities on hip fracture risk amongst elderly men. We demonstrated that diabetes, chronic obstructive pulmonary disease, renal failure, HIV infection, dementia, and cerebrovascular disease are independent predictors of hip fracture, as is a Charlson score of ≥3. Risk factors for hip fractures in men are still unclear. We aimed to identify common co-morbidities (amongst those in the Charlson index) that confer an increased risk of hip fracture amongst elderly men. We conducted a population-based cohort study using data from the SIDIAP (Q) database. SIDIAP(Q) contains primary care and hospital inpatient records of a representative 30 % of the population of Catalonia, Spain (>2 million people). All men aged ≥65 years registered on 1 January 2007 were followed up until 31 December 2009. Both exposure (co-morbidities in the Charlson index) and outcome (incident hip fractures) were ascertained using ICD codes. Poisson regression models were fitted to estimate the effect of (1) each individual co-morbidity and (2) the composite Charlson index score, on hip fracture risk, after adjustment for age, body mass index, smoking, alcohol drinking, and use of oral glucocorticoids. We observed 186,171 men for a median (inter-quartile range) of 2.99 (2.37-2.99) years. In this time, 1,718 (0.92 %) participants had a hip fracture. The following co-morbidities were independently associated with hip fractures: diabetes mellitus, chronic obstructive pulmonary disease (COPD), renal failure, HIV infection, dementia, and cerebrovascular disease. A Charlson score of ≥3 conferred an increased hip fracture risk. Common co-morbidities including diabetes, COPD, cerebrovascular disease, renal failure, and HIV infection are independently associated with an increased risk of hip fracture in elderly men. A Charlson score of 3 or more is associated with a 50 % higher risk of hip fracture in this population.
    Osteoporosis International 03/2014; 25(6). DOI:10.1007/s00198-014-2682-9 · 4.17 Impact Factor
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    ABSTRACT: Background Sclerostin is an osteocyte-derived inhibitor of osteoblast activity. The monoclonal antibody romosozumab binds to sclerostin and increases bone formation. Methods In a phase 2, multicenter, international, randomized, placebo-controlled, parallel-group, eight-group study, we evaluated the efficacy and safety of romosozumab over a 12-month period in 419 postmenopausal women, 55 to 85 years of age, who had low bone mineral density (a T score of -2.0 or less at the lumbar spine, total hip, or femoral neck and -3.5 or more at each of the three sites). Participants were randomly assigned to receive subcutaneous romosozumab monthly (at a dose of 70 mg, 140 mg, or 210 mg) or every 3 months (140 mg or 210 mg), subcutaneous placebo, or an open-label active comparator oral alendronate (70 mg weekly) or subcutaneous teriparatide (20 g daily). The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months. Secondary end points included percentage changes in bone mineral density at other sites and in markers of bone turnover. ResultsAll dose levels of romosozumab were associated with significant increases in bone mineral density at the lumbar spine, including an increase of 11.3% with the 210-mg monthly dose, as compared with a decrease of 0.1% with placebo and increases of 4.1% with alendronate and 7.1% with teriparatide. Romosozumab was also associated with large increases in bone mineral density at the total hip and femoral neck, as well as transitory increases in bone-formation markers and sustained decreases in a bone-resorption marker. Except for mild, generally nonrecurring injection-site reactions with romosozumab, adverse events were similar among groups. Conclusions In postmenopausal women with low bone mass, romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption. (Funded by Amgen and UCB Pharma; ClinicalTrials.gov number, NCT00896532.)
    New England Journal of Medicine 01/2014; 370(5). DOI:10.1056/NEJMoa1305224 · 54.42 Impact Factor
  • Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A136-A137. DOI:10.1136/annrheumdis-2013-eular.453 · 9.27 Impact Factor

Publication Stats

3k Citations
704.46 Total Impact Points

Institutions

  • 2002–2015
    • Autonomous University of Barcelona
      • Department of Medicine
      Cerdanyola del Vallès, Catalonia, Spain
  • 2010–2014
    • Instituto de Salud Carlos III
      Madrid, Madrid, Spain
    • Institut Marqués, Spain, Barcelona
      Barcino, Catalonia, Spain
  • 2009–2014
    • IMIM Hospital del Mar Medical Research Institute
      Barcino, Catalonia, Spain
  • 2003–2014
    • Parc de Salut Mar
      Barcino, Catalonia, Spain
  • 2001–2014
    • Consorci MAR Parc de Salut de Barcelona
      Barcino, Catalonia, Spain
  • 2012
    • Parc de recerca biomedica de barcelona
      Barcino, Catalonia, Spain
  • 2000–2012
    • University of Barcelona
      • Department of Medicine
      Barcino, Catalonia, Spain
  • 2007–2008
    • Universidad Autónoma de Madrid
      Madrid, Madrid, Spain
  • 2006
    • The University of Edinburgh
      • Rheumatic Diseases Unit
      Edinburgh, SCT, United Kingdom
    • Eli Lilly
      Indianapolis, Indiana, United States
    • Erasmus MC
      • Department of Internal Medicine
      Rotterdam, South Holland, Netherlands