Description

Subprojects

• ESOSVAL-R: Development and validation of a population scale for the prediction of osteoporotic fracture in the Valencian Community.
• ESOSVAL-AD: Adherence and adequacy of osteoporotic treatment in the Valencian Community treatment at discharge, adherence and clinical results after hospitalization for hip fracture.

Objevtives

• To develop an osteoporotic fracture prediction scale in the adult population of the Valencian Community and to evaluate its validity.
• To estimate the incidence of densitometry and preventive treatments and their predictors.
• Assess the adherence and therapeutic adequacy of anti-osteoporotic treatments in patients aged over 50 in the Valencian Community.

State

Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study.

• A study to evaluate the impact of a combined intervention (in-class and on-line training courses, a practicum and economic incentives) to improve anti-osteoporosis treatment and to improve recordkeeping for specific information about osteoporosis.
   
• Main Objective: To evaluate the impact of a multifaceted intervention on the improvement of the appropriateness of anti-osteoporosis treatment and on the inclusion of specifically related to osteoporosis information in the electronic clinical records.

Adherence to and appropriateness of anti-osteoporotic treatments in patients aged 50 and over in the Valencia Region (Spain). The ESOSVAL-AD Study.

• A study to evaluate the adherence to and appropriateness of anti-osteoporotic treatments in a cohort of men and women aged 50 and over participating in the ESOSVAL-R study.
   
• Main Objective: To describe the adherence to and appropriateness of the indications of anti-osteoporotic treatments in a cohort of men and women aged 50 and over who began an anti-osteoporotic treatment in 2009-2010 and who were included in the ESOSVAL-R cohort; and to analyze the relationships between adherence and appropriateness as well as between fracture risk and adherence and appropriateness.

Prevalence of osteoporotic fracture risk factors and antiosteoporotic treatments in the Valencia region, Spain. The baseline characteristics of the ESOSVAL cohort.

• This study provides information on the prevalence of the most important risk factors for osteoporosis and osteoporotic fracture in a large sample of women and men from the Valencia region and also provides the FRAX 10-year major and hip fracture risks for this population, as well as data about the use of diagnostic tests and antiosteoporotic treatments.
   
• Results: The mean age of participants was 64.3 years old for women and 65.6 years old for men. The most frequent fracture risk factors were sedentary life (22.2 %) and previous fracture (15.8 %) in women and low calcium intake (21.4 %) and current smoker (20.9 %) in men. According to FRAX®, the 10-year risk of presenting a major fracture was 5.5 % for the women and 2.8 % for the men. The 10-year risk for hip fracture was 1.9 and 1.1 % for the women and the men, respectively; 23.8 % of the women and 5.2 % of the men had a densitometry test, 27.7 % of the women and 3.5 % of the men were taking calcium and/or vitamin D supplements, and 28.2 % of the women (22.0 % in the 50–64 age group) and 2.3 % of the men were taking antiosteoporotic drugs.
   
• Conclusions: The prevalence of certain fracture risk factors not included in the FRAX tool (sedentary life, falls, low calcium intake) is high. In young women, their low risks estimated by FRAX contrast with the high figures for densitometry testing and treatment.

Prevalence, determinants, and inappropriateness of calcium supplementation among men and women in a Spanish Mediterranean area: Cross-sectional data from the ESOSVAL cohort.

• The aimed is to describe the use of calcium and vitamin D supplements, the factors related to it, and to assess the appropriateness of calcium prescription among men and women aged 50 years or older.
   
• In conclusion, we found high inappropriateness of calcium supplementation, mainly because of calcium overdosing, and also to undertreatment and underdosing of vitamin D in high-risk patients. Physicians should be encouraged to assess calcium dietary intakes before supplementation, recommending intake from food whenever possible, and to prescribe low calcium doses and high vitamin D doses when given in fixed-dose combinations, or vitamin D alone when calcium is not necessary.

Impact on the Population of Different Bone Mineral Density Testing Criteria and Appropriateness of Densitometries in the ESOSVAL Cohort, Spain.

• The aim of this study was to estimate the impact on the population of the application of the BMD testing criteria provided by the National Osteoporosis Guideline Group (NOGG), National Osteoporosis Foundation (NOF), and Osteoporosis Canada and to assess the appropriateness of the BMD tests currently performed.
   
• Conclusions: The impact on the population of the different recommendations is enormous, varying from 17% to 80% of the population over 50 who would be tested. Although in men it seems that a clinical rationale exists between the presence of risk factors and the rates of BMD testing, this pattern does not seem to exist in women. One in 10 of the densitometric tests performed were inappropriate according to all the guidelines.

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

• The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valencia (Spain) after safety warnings from regulatory agencies and cost-sharing changes, according to patient socio-demographic and risk of fracture characteristics.
   
• Results: The AEMPS Osteonecrosis Jaw Warning was not associated with a decline in the consumption of osteoporosis drugs, while the warning on atypical fracture (a downward trend of 0.11% fewer people treated each month) and the increase in the cost-sharing scheme (immediate change level of -1.07% in the proportion of people treated) were associated with a strong decline in the proportion of patients treated, so that by the end of 2015 osteoporosis drug consumption was around half that of 2009. The relative decline was similar in people with both a high and low risk of fracture.
   
• Conclusion: The AEMPS Atypical femur Fracture Warning of Apr 2010 was associated with a significant decrease in the number of people treated, reinforced by the increase in the pharmaceutical cost-sharing in 2012. Decreases in treatment affected patients both at a low and higher risk of fracture.

Predictive Performance of the FRAX Tool Calibrated for Spain vs. an Age and Sex Model: Prospective Cohort Study with 9082 Women and Men Followed for up to 8 Years.

• In Spain, the Fracture Risk Assessment Tool (FRAX) was adapted using studies with a small number of patients, and there are only a few external validation studies that present limitations. In this prospective cohort study, we compared the performance of FRAX and a simple age and sex model. We used data from the ESOSVAL cohort, a cohort composed of a Mediterranean population of 11,035 women and men aged 50 years and over, followed for up to 8 years, to compare the discrimination, calibration, and reclassification of FRAX calibrated for Spain and a logistic model including only age and sex as variables. We found virtually identical AUC, 83.55% for FRAX (CI 95%: 80.46, 86.63) and 84.10% for the age and sex model (CI 95%: 80.91, 87.29), and there were similar observed-to-predicted ratios. In the reclassification analyses, patients with a hip fracture that were reclassified correctly as high risk by FRAX, compared to the age and sex model, were −2.86%, using either the 3% threshold or the observed incidence, 1.54% (95%CI: −8.44, 2.72 for the 3% threshold; 95%CI: −7.68, 1.97 for the incidence threshold). Remarkably simple and inexpensive tools that are easily transferable into electronic medical record environments may offer a comparable predictive ability to that of FRAX.

Funding