ABSTRACT. Objective. Vertebral fractures are a common complication of osteoporosis and may have a negative effect on health-related quality of life (HRQOL). We investigated the effect of prevalent vertebral fractures on HRQOL in patients with osteoporosis. Methods. A cross-sectional multicenter study was carried out among postmenopausal women with primary osteoporosis attending primary care centers and hospital outpatient clinics: 234 women with vertebral fractures and 244 asymptomatic women. Women with secondary osteoporosis or taking medications that affect bone metabolism were excluded. All patients were questioned using the miniOsteoporosis Quality of Life Questionnaire (mini-OQLQ), Medical Outcomes Study Short , and the EuroQuol-5D, after assessment of all clinical variables and anthropometric data. To assess comorbidity we used the Self-Administered Comorbidity Questionnaire (SCQ). Diagnosis of osteoporosis was confirmed in all patients by bone mineral density using dual energy x-ray absorptiometry. Radiographic evaluation was performed by a musculoskeletal radiologist. A total of 483 postmenopausal women, randomly matched for age out of 1579 healthy controls, were chosen to compare the SF-36 scores with respect to patients with and without vertebral fractures due to osteoporosis. A multivariable regression analysis was conducted to identify the strongest determinant for low HRQOL, adjusted for potential confounding variables such as comorbid conditions, education level, and psychosocial status. Results. The vertebral fracture group had significantly lower scores than patients without fractures and controls in all domains of the generic and specific questionnaires. Women with only 1 prevalent fracture had statistically significantly lower HRQOL scores than those without fractures on SF-36 measures of bodily pain, physical functioning, and role function physical (all p < 0.01). HRQOL scores were lower in women with lumbar fractures compared with women with thoracic fractures only when the physical functioning and bodily pain dimensions approached statistical significance. Based on the multivariate analysis, the strongest determinant for low HRQOL was physical functioning (explained by number of vertebral fractures) followed by comorbidity score and age. Adjusted R 2 in the final model was 35.9%. Using the SF-36 summary scales, comorbid conditions predominantly affected either mental or physical health (p < 0.0001). A significant correlation (p < 0.0001) was found between total score on the mini-OQLQ and the mean SCQ comorbidity score. Conclusion MATERIALS AND METHODS Recruitment of patients. In this cross-sectional multicenter study we investigated 478 postmenopausal women (mean age 68.5 yrs, range 48-89 yrs) with primary clinically stable osteoporosis (no change in treatment and no new clinical deformities in the last 12 mo) attending primary care centers and hospital outpatient clinics. The patient group included 234 women (mean age 69 yrs, range 48-89) who had vertebral fractures due to osteoporosis, and a group of 244 asymptomatic osteoporotic women matched for age with the patients with vertebral fractures. The women were screened in 5 rheumatology centers in Northern and Central Italy. A simple algorithm, the OPERA 23 , based on age, weight, history of previous low impact fracture, early menopause, and corticosteroid therapy, was used as a prescreening tool to help clinicians identify which women are at increased risk for osteoporosis. Diagnosis of osteoporosis was confirmed by bone mineral density (BMD) using dual-energy x-ray absorptiometry (DEXA). Osteoporosis was defined as a T score lower than -2.5 (the difference between the measured BMD and the mean value of young adults, expressed in standard deviations), according to the World Health Organization Study Group definition 24 . All measurements at the left femoral neck and lumbar spine (L1-L4), in the anteroposterior position, were obtained using the Hologic scanner (Hologic QDR 4500; Hologic, Bedford, MA, USA). One of the inevitable limitations of the study was the use of different densitometry machines, yielding noncomparable BMD data. Thus, machines at each participating center were cross-calibrated at the beginning of the study using the same spine phantom (supplied by the manufacturer). Each phantom was scanned 10 times at each study center. Quality control procedures were followed according to the manufacturer's recommendations. T scores were based on a large European and US reference database for BMD 25 . Radiographic evaluation was performed centrally (at the Department of Radiology of the Università Politecnica delle Marche) by an experienced musculoskeletal radiologist. Total spine radiographs in lateral standing views in neutral/flexion/extension and in the lateral decubitus position in flexion/extension were taken with a film-tube distance of 1.8 m. The anterior, central, and posterior heights of each of the vertebral bodies from T4 to L5 in a neutral standing radiograph were measured using calipers. Vertebral fracture was considered present if at least one of 3 height measurements (anterior, middle, posterior) of one vertebra had decreased by more than 20% compared with the height of the nearest uncompressed vertebral body Further, 483 postmenopausal women (mean age 69.1 yrs, range 50-87) randomly matched for age out of 1579 healthy controls were chosen for comparison of SF-36 scores of patients with and without vertebral fractures due to osteoporosis. Subjects with fibromyalgia, chronic back pain, and vertebral or other fractures were excluded. As acquisition of radiographs in the control group study was considered unethical in the context of the study, inclusion in this group depended on oral confirmation that the individual had never 1552 The received a clinical diagnosis of vertebral or other fracture. This sample was selected from a previous cross-sectional population-based study, the MAP-PING (MArche Pain Prevalence INvestigation Group) study Background and illness-related variables. Demographic and socioeconomic information was assessed from patient interviews. Education level was separated into 3 categories based on the Italian school system: 1 = primary school, 2 = secondary school, and 3 = high school or university. The body mass index (BMI, body weight/height 2 ) was used to assess overweight. In all patients the presence of comorbidities was also assessed through patient self-reports using the Self-Administered Comorbidity Questionnaire (SCQ) 28 , a modification of the widely used Charlson Index 29 . The SCQ uses patient interview or questionnaire responses rather than chart abstraction for assessment of comorbidity and is in excellent agreement with the chart-based Charlson Index 28 . We evaluated the rate of endorsement of each of 12 specific conditions as well as the number of conditions endorsed. We also calculated a score with 1 point if the condition was endorsed and additional points if the subject reported currently receiving treatment for it, or if it limited activities. Each condition could, therefore, contribute 0 to 3 points for a maximum of 36 points
