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Vertebral fractures are a common complication of osteoporosis and may cause a decrease of health-related quality of life (HRQOL). This study was designed to determine the impact of incident vertebral fractures on HRQOL. The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double blind trial, in which women were taking raloxifene or placebo. This study was done in European centers only in a subset of 361 women from seven European countries, all with prevalent vertebral fractures. A specific questionnaire for osteoporosis developed by the International Osteoporosis Foundation was used for assessment at baseline, 1, 2 and 3 years. This questionnaire, Qualeffo, contains 41 questions in the domains pain, physical function, social function, general health perception and mental function. Domain and total scores are expressed on a 100-point scale with 0 corresponding to the best HRQOL. Standardized lateral spinal radiographs were made at baseline, 2 and 3 years and evaluated in a central facility. Sixty-seven patients sustained a fracture in a vertebra that was not fractured at baseline (incident vertebral fractures). Twenty of these were accompanied by signs and symptoms necessitating immediate doctor’s attention (clinical vertebral fractures) and 47 vertebral fractures were only diagnosed on radiographs (subclinical vertebral fractures). Incident vertebral fractures (clinical and subclinical) were associated with an increase of back pain (mean score change 6.4; 95% CI 2.1–10.7), deterioration of physical function (mean score change 2.4; 95% CI 0.1–4.8), and worse general health perception (mean score change 3.8; 95% CI 0.1–7.5). Score changes for patients with subclinical vertebral fractures were intermediate between those for patients with clinical vertebral fractures and patients without incident vertebral fracture. Clinical and subclinical incident vertebral fractures both have an adverse impact on HRQOL. [ABSTRACT FROM AUTHOR]

Complaints regarding, and morbidity of, osteoporosis are caused by fractures which are associated with pain and decrease of physical function, social function, and well-being. These are aspects of quality of life. Health-related quality of life covers physical, mental, and social well-being. Quality of life may be measured for evaluation of treatment effects in clinical trials, for the assessment of the burden of the disease of osteoporosis, and for estimates of the cost-effectiveness of different treatment scenarios in health care policy. Quality of life has been measured in patients with osteoporosis with generic questionnaires such as SF-36 and EQ-5D, which can be used in many diseases, or with one of the six available osteoporotic-specific questionnaires, e.g., Qualeffo-41 or OPAQ. Every questionnaire has to be validated to assess psychometric properties and discrimination power between patients with osteoporosis and control subjects. The value attached to specific health states (utility) can be assessed with some generic instruments or by systematic questioning of the patient, e.g., the time-trade-off method. This results in one value for health status ranging from 0 (death) to 1 (perfect health). Utility values can be used to calculate loss of quality-adjusted life years (QALY). Most data have been obtained in patients with prevalent vertebral fractures. Scores of specific and generic questionnaires showed significant loss of quality of life with prevalent vertebral fractures. In addition, studies with Qualeffo-41 and OPAQ showed a deteriorating quality of life with increasing number of vertebral fractures. Lumbar fractures had more impact on quality of life than thoracic fractures. Incident vertebral fractures were also associated with a decrease of quality of life especially in the physical function domain. This applied to clinical incident vertebral fractures as well as to subclinical fractures to a lesser degree. Loss of quality of life following hip fracture has been documented with generic and osteoporosis-specific questionnaires. A considerable loss was observed in the 1st year with some improvement in the 2nd year, but not to baseline values. Quality of life depended on comorbidity, mobility, activities of daily life (ADL)-independence, and fracture complaints. Utility loss has been observed following hip fracture, especially disabling hip fracture, hip and vertebral fracture combined, or multiple vertebral fractures. Utility following osteoporotic fractures has been valued by patients, the healthy elderly, and panels of experts. The healthy elderly gave the worse quality-of-life scores (lower utility) to various hip fractures than patients with hip fractures themselves. In conclusion, suitable instruments exist for measuring quality of life in patients with osteoporotic fractures. These instruments are useful for clinical trials and for assessment of the burden of disease. [ABSTRACT FROM AUTHOR]