Long-term quality of life and influencing factors in elderly patients after vertebroplasty based on the EQ-5D-3L Chinese utility scoring system: a retrospective study.

BACKGROUND: The quality of life of elderly patients after vertebroplasty is influenced by various factors. Although the EuroQol 5-Dimension 3-Level (EQ-5D-3L) scale has been widely used to assess quality of life, the factors affecting the long-term postoperative quality of life of elderly vertebroplasty patients in China have not been thoroughly studied. METHODS: This retrospective study included 519 patients aged 65 years and older who underwent elective vertebroplasty. We collected baseline data from these patients and conducted telephone follow-ups 12 months postoperation to evaluate their EQ-5D-3L health utility scores and EuroQol Visual Analogue Scale (EQ-VAS) scores. Univariate and multivariate linear regression models were used to analyse the factors affecting quality of life. RESULTS: Of the 519 patients, the majority were female (78.0%), aged 65 to 95 years, with an average age of 75.2 years. Twelve months postoperation, pain/discomfort was the most commonly reported issue for 68.4% of patients. The median EQ-5D-3L health utility score was 0.783, with a range between 0.450 and 0.887; the median EQ-VAS score was 75, ranging from 60 to 85. Multivariate linear regression analysis indicated that older age, hormone use, higher American Society of Anesthesiologists (ASA) grades, nondrinking habits, and low albumin levels were found to be independent risk factors affecting long-term quality of life in elderly patients after vertebroplasty. Additionally, a history of tumours, the number of vertebral compression fractures, and bone mineral density were also crucial influencing factors. CONCLUSIONS: Based on the use of the EQ-5D-3L Chinese utility scoring system, we evaluated the quality of life of patients aged 65 and above 12 months after vertebroplasty. This study identified several factors related to postoperative quality of life in elderly vertebroplasty patients, providing crucial evidence for further clinical decisions and patient education.

Do the management and functional outcomes of the surgically treated spinal fractures change in suicidal jumpers?

PURPOSE: The aim of the study was to determine the effect of trauma etiology on the management, functional outcomes and psychiatric characteristics of suicide jumpers and patients who accidentally fall from height. METHODS: 89 patients (48 accidental falls and 41 suicidal jumpers) who had undergone spinal surgery were included in the study. The patients were evaluated clinically and radiologically. Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and McGill Pain Questionnaire (MPQ) were performed for functional evaluation. BECK hopelessness scale (BHS), BECK depression inventory (BDI), and SF-36 scales were used for the psychiatric evaluation. All outcomes were compared between suicidal jumpers and accidental falls. RESULTS: The RMDQ and ODI questionnaires stated a higher disability in the suicide jump group (p = 0.001 and p = 0.029, respectively). However, the VAS and MPQ questionnaires did not differ in significance between groups (p = 0.182 and p = 0.306, respectively). The SF-36 scale showed that physical function, role emotional, vitality and mental health subdomains were worse in the suicide jump group (p = 0.001, p = 0.029, p = 0.014 and p = 0.030, respectively). BDI scores were significantly higher in the suicide jump group while no difference was observed between the groups in terms of BSH (p = 0.017 and p = 0.940, respectively). CONCLUSION: Psychiatric disorders are more common in patients in the suicidal jumpers. The presence of underlying psychiatric problems adversely affects the postoperative functional outcomes of patients with surgically treated spinal fractures. A multidisciplinary approach together with raising awareness in this way can improve the clinical outcomes after orthopedic treatment, even if there is physical disability.

Predictors for quality of life improvement after acute osteoporotic vertebral fracture: results of post hoc analysis of a prospective randomized study.

PURPOSE: No study has investigated the clinical and radiographic risk factors for the deterioration of quality of life (QOL) beyond 6 months after osteoporotic vertebral fractures (OVF). The purpose of this study was to identify the predictors associated with poor QOL improvement after OVF. METHODS: This post hoc analysis included 166 women aged 65-85 years with acute 1-level OVFs. For the patient-reported outcome measures, scores on the European Quality of Life-5 Dimensions (EQ-5D) scale, and visual analogue scale (VAS) for low back pain were used. Lateral radiography at 0, 12, and 48 weeks and magnetic resonance imaging (MRI) at enrollment and at 48 weeks were performed. The associations between baseline variables with change scores for EQ-5D were investigated using a multiple linear regression model. RESULTS: Univariate analysis showed that time since fracture, EQ-5D score, and VAS for low back pain at 0 week showed significant association with increased EQ-5D score from 0 to 48 weeks. According to the multiple regression analysis, the following equation was obtained: increased EQ-5D score from 0 to 48 weeks = 1.305 - 0.978 × EQ-5D at 0 week - 0.021 × VAS for low back pain at 0 week - 0.006 × age + (fluid-intensity T2-weighted MR image patterns: - 0.037, except for fluid-intensity T2-weighted MR image patterns: + 0.037). CONCLUSION: In conclusion, older patients with severe low back pain and fluid-intensity T2-weighted MR image patterns were more likely to have lower QOL improvements after OVFs and may therefore need extra support to improve QOL.

Factors Affecting Quality of Life at Discharge among Patients with Osteoporotic Vertebral Fractures.

OBJECTIVES: This study aimed to identify factors, including physical functions and activities that affect quality of life (QOL) at discharge among patients with osteoporotic vertebral fractures. METHODS: Patients with osteoporotic vertebral fractures were included in our prospective cohort study. Multiple regression analysis was performed to determine the predictors of QOL at discharge using two models: model 1, basic medical information and physical functions at admission, and model 2, basic medical information, physical function, and activity after 4 weeks of admission. RESULTS: Multiple regression analysis (standard partial regression coefficients) using model 1 identified L2 to L4 bone mineral density (-0.2), Visual Analog Scale for pain during activity at admission (-0.31), and Revised Hasegawa Dementia Scale (HDS-R) score at admission (0.64) as factors affecting QOL at discharge. Multiple regression analysis using model 2 identified HDS-R at admission (0.64), Pain Catastrophizing Scale score at 4 weeks (-0.34), and knee extension muscle strength at 4 weeks (0.28) as factors affecting QOL at discharge. CONCLUSIONS: Our results suggest that if patients have high bone mineral density, intense pain, and low cognitive function at admission, then low QOL at discharge will be predicted; however, improvement of pain catastrophizing and knee extension muscle strength during first the 4 weeks of admission may be able to improve QOL at discharge. Because patients in this study were Japanese only, it is important to exercise caution when applying our results to other populations.

What Is the Difference in the Risk of Suicide Death Between Spine Fracture in Patients Older Than 65 Years and Matched Controls? A Large-database Study from South Korea.

BACKGROUND: Pain and kyphotic deformity after spinal fractures can result in a decrease in a patient's physical function and quality of life. Furthermore, physical illness, such as respiratory compromise, or mental illness, including depression, may be exacerbated by a spinal fracture. Complications caused by spinal fractures and old age are risk factors for suicide, but studies on these patients are rare. QUESTIONS/PURPOSES: (1) What is the incidence rate of death by suicide after a spinal fracture in patients older than 65 years? (2) How much does the risk of death by suicide increase in patients older than 65 years who have spine fractures compared with well-matched controls? (3) How does this risk change as a function of increasing time after injury? METHODS: Spinal fractures in patients older than 65 years and matched controls were selected from the National Health Insurance Service-Senior cohort (NHIS-Senior) of South Korea. The NHIS-Senior consists of 558,147 people selected by 10% simple random sampling method from a total of 5.5 million people 60 and older in 2002; all people were followed through 2015. A total of 31,357 patients with spine fractures and their 62,714 matched controls remained in the study. The mean follow-up time was 4.3 ± 3.0 years (135,229 person-years) in the spine fracture group and 4.6 ± 3.0 years (290,096 person-years) in the matched control group. We matched the groups for demographic factors such as age, gender, Charlson Comorbidity Index score, medication history, medical history, preoperative disability, number of hospital admissions, as well as socioeconomic factors such as household income level, residential district, and type of national health insurance using a 1:2 risk set propensity score matching by a nearest-neighbor matching algorithm with a maximum caliber of 0.1 of the hazard components. The incidence rate of suicide and the 95% confidence interval were calculated based on a generalized linear model with a Poisson distribution. The effect size was presented as a hazard ratio (HR) using Cox's proportional hazard model with robust variance estimator that accounts for clustering within matched pairs. RESULTS: The overall risk of death by suicide throughout the surveillance period, expressed as an incidence rate, was 116 per 100,000 person-years in spinal fracture (157 deaths by suicide over 135,229 person-years). Throughout the entire surveillance period, the risk of death by suicide was greater among patients with spinal fractures than it was in the control group (HR 1.8 [95% CI 1.5 to 2.2]; p < 0.01). This difference was greatest in the first 365 days after the fracture (HR 2.5 [95% CI 1.6 to 3.8]; p < 0.01) (45 deaths by suicide, incidence rate: 156 per 100,000 person-years in spinal fracture). The risk of suicide death in patients with spine fracture from 365 days to the last follow-up was also higher than that of matched controls (HR 1.6 [95% CI 1.3 to 2.1]; p < 0.01). CONCLUSIONS: Considering the substantially increased risk of death by suicide in patients with spine fractures who are older than 65 years, surgeons should consider offering psychiatric evaluation and management more frequently, particularly in patients with chronic pain, functional disability, and depressive mood. Future studies should investigate the underlying causes of suicide, such as deteriorating socioeconomic support or depression, and whether early initiation of psychological support after injury can reduce the suicide rate. LEVEL OF EVIDENCE: Level III, prognostic study.

Men's experiences of having osteoporosis vertebral fractures: a qualitative study using interpretative phenomenological analyses.

Men and women with vertebral fractures due to osteoporosis are treated differently by society and health care professionals. This can lead to inequalities in health care and affects how men with fractures view themselves as people. We need to raise awareness that men get these fractures as well as women. INTRODUCTION: There is a lack of research exploring the experience of osteoporosis from the male perspective. This study was undertaken to explore and describe the experiences of men with vertebral fractures due to osteoporosis, including their perceptions of diagnosis, treatment and changes in their sense of self. METHODS: The study consists of in-depth semi-structured interviews with nine male participants of the PROVE (Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture) study. Interviews were digitally audio recorded and fully transcribed. Data were coded in accordance with an interpretative phenomenological analysis approach to analyses. RESULTS: Three main themes are presented. (i) Osteoporosis is considered an old women's disease. (ii) Men are diagnosed and treated differently than women in the NHS. Health care inequalities exist. (iii) Changes in self can occur in men after vertebral fracture/s due to osteoporosis. CONCLUSIONS: Greater awareness that men get this condition is needed in both society in general and also by health care professionals who often do not expect osteoporosis to affect men. Approaches to diagnosis and treatment need to be considered and improved to ensure that they become appropriate and effective for men as well as women.

Associations between health-related quality of life, physical function and pain in older women with osteoporosis and vertebral fracture.

BACKGROUND: Osteoporosis and vertebral fractures represent a major health burden worldwide, and the prevalence of osteoporosis is expected to increase as the world's population ages. Suffering from vertebral fracture has a substantial impact on the individual's health-related quality of life (HRQoL), physical function and pain. Complex health challenges experienced by older people with osteoporosis and vertebral fractures call for identification of factors that may influence HRQoL, as some of these factors may be modifiable. The objective is to examine the independent associations between HRQoL, physical function and pain in older women with osteoporosis and vertebral fracture. METHODS: This study has a cross-sectional design, using data from 149 home-dwelling Norwegian women with osteoporosis and vertebral fracture, aged 65+. Data on HRQoL (Short Form 36 (SF-36), Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)), physical function (walking speed, balance and strength), pain, as well as sociodemographic information were collected. Simple linear regression analyses were conducted and multivariable regression models were fitted to investigate the associations. RESULTS: Lower levels of HRQoL were significantly associated with lower levels of physical function, measured by walking speed, and higher levels of pain. Pain was significantly associated with all of the subscales in SF-36, with the exception of Mental Health and Mental Component Score, and all the subscales of QUALEFFO-41. Walking speed was significantly associated with 5 of 8 subscales of SF-36 (except Bodily Pain, Vitality, Mental Health and Mental Component Score), and with 4 of 6 subscales of QUALEFFO-41 (except Score Pain and Mood). CONCLUSION: This study shows that pain and walking speed were, independently of one another, associated with HRQoL in older women with osteoporosis and vertebral fracture. These findings can inform clinicians and health managers about the importance of pain management and exercise interventions in health care for this group. Future research should address interventions targeting both physical function and pain with HRQoL as an outcome. REGISTRATION: ClincialTrials.gov Identifier: NCT02781974. Registered 18.05.16. Retrospectively registered.

The effects of person-centered or other supportive interventions in older women with osteoporotic vertebral compression fractures-a systematic review of the literature.

Vertebral compression fracture (VCF) is a common fragility fracture and the starting point of a lasting, painful, disabling condition. The aim was to summarize evidence of person-centered/non-medical interventions supporting women with VCF. Results show small numbers of studies with only probable effect on function, pain, QoL, fear of falling, and psychological symptoms. The vertebral compression fracture (VCF) caused by osteoporosis is the third most common fragility fracture worldwide. Previously, it was believed that the pain caused by VCF was self-subsiding within weeks or a few months post-fracture. However, this positive prognosis has been refuted by studies showing that, for the great majority of patients, the VCF was the starting point of a long-lasting, severely painful, and disabling condition. The low number of studies focusing on the experience of the natural course of VCF, and what support is available and how it is perceived by those affected, calls for further investigation. Strengthening older patients' sense of security and increasing confidence in their own abilities are of great importance for successful rehabilitation following VCF. More research is needed to identify resources, possibilities, and strategies that can assist older patients to reach their goals to improve well-being. The purpose of this systematic review was to identify and summarize the current evidence of person-centered or other structured non-medical/non-surgical interventions supporting older women after experiencing an osteoporotic VCF. A systematic literature search was conducted on the MeSH terms encompassing osteoporosis and vertebral compression fractures in the PubMed-MEDLINE and Cumulative Index for Nursing and Allied Health Literature (CINAHL) databases during March through June 2015. The initial search identified 8789 articles, but only seven articles (six randomized controlled trials and one observational study with a control group) met the inclusion criteria. It became evident from the current study that the availability of evidence on the effects of non-medical interventions aiming to support older women with VCF is limited, to say the least. The trials included in this review have few limitations and were mainly considered to be of moderate quality. This systematic literature review suggests that non-medical interventions aiming to support older women with VCF might decrease levels of pain and use of analgesic as well as promote improved physical mobility and function. These interventions would probably result in an improved difference in experiences of fear of falling and perceived psychological symptoms, but would only slightly improve quality of life. However, given the nature of the seven studies, potential biases in patient selection, issues around precision with small cohorts, and failure to control for confounders, makes it difficult to draw a definitive conclusion about the significant effects of non-medical interventions. Incurring a VCF is a complex and diverse event, necessitating equally complex interventions to identify new ways forward. However, to date, interventions struggle with a risk of selection bias in that only the needs of the healthiest of the population are addressed and the voices of the remaining majority of the people affected by VCF are unheard.

[Preoperative, neuropathic component in patients with back pain]. / Präoperative, neuropathische Komponente bei Rückenschmerzen.

BACKGROUND: The objectification of pain is essential for evaluation, treatment plan and follow-up; therefore, it is necessary to find reliable clinical parameters. OBJECTIVE: The goal of the study was the preoperative screening of a neuropathic component in patients with vertebral compression fracture (WKF), herniated disc (NPP) or spinal cord compression (SKS). MATERIAL AND METHODS: Depending on the preoperative condition on admittance, patients were classified into three groups: group 1 WKF, group 2 NPP and group 3 SKS. To characterize the pain we used the painDETECT questionnaire, the Oswestry questionnaire and further questionnaires. All patients were surgically treated according to the diagnosis, e.g. radiofrequency kyphoplasty, nucleotomy or spondylodesis. RESULTS: We evaluated the data from 139 patients (45% WKF, 34% NPP and 21% SKS). There were no differences in preoperative pain intensity (median ordinal scale 0-10) with a mean preoperative score of 7 for all groups. The total score of the painDETECT questionnaire showed significantly higher results in group 2 (median 18) and in group 3 (median 14) than in group 1 (median 9). There was even a significant difference between groups 2 and 3 (p = 0.03). The highest pain intensity was detected in group 1 with a median visual analog scale (VAS) of 71 mm. The total scores in the painDETECT questionnaire and the scores in the Oswestry questionnaire correlated in groups 2 and 3. CONCLUSION: The painDETECT questionnaire was shown to be a very suitable instrument for evaluating the neuropathic pain component in patients with dorsalgia. This could be very useful in planning further therapy.

A painful, never ending story: older women's experiences of living with an osteoporotic vertebral compression fracture.

UNLABELLED: Vertebral compression fractures (VCF) cause pain and decreased physical ability, with no known well-established treatment. The aim of this study was to illuminate the experience of living with a VCF. The results show that fear and concerns are a major part of daily life. The women's initial contact with health-care providers should focus on making them feel acknowledged by offering person-centered and tailored support. INTRODUCTION: In the past decade, osteoporotic-related fractures have become an increasingly common and costly public health problem worldwide. Vertebral compression fracture (VCF) is the second most common osteoporotic fracture, and patients with VCF describe an abrupt descent into disability, with a subsequent desire to regain independence in everyday life; however, little is known of their situation. The aim of this study was to illuminate the lived experience of women with an osteoporotic VCF. METHODS: Ten women were interviewed during 2012-2013, starting with an open-ended question: could you tell me what it is like to live with a vertebral compression fracture? The verbatim transcribed interviews were analyzed using a phenomenological hermeneutical approach. RESULTS: The narrative provided descriptions of living in turmoil and chaos, unable to find stability in their life with little improvement regarding pain and physical function. Shifts from periods of constant pain to periods of fear of constant pain created a loss of confidence and an increased sense of confinement. The structural analysis revealed fear and concerns as the most prominent experience building on five themes: struggling to understand a deceiving body, breakthrough pain fueling fear, fearing a trajectory into isolation, concerns of dependency, and fearing an uncertain future. CONCLUSIONS: Until researchers find a successful prevention or medical/surgical treatment for osteoporotic VCFs, health-care providers and society abandon these women to remain in a painful and never ending story.

Contribution of catastrophizing to disability and pain intensity after osteoporotic vertebral compression fracture.

BACKGROUND: Pain catastrophizing is a key variable that contributes to disability not only in chronic pain disorders but also after trauma. However, there is little evidence concerning the effect of catastrophizing on pain intensity and disability after osteoporotic vertebral compression fracture. Therefore, the purpose of this study was to evaluate the contribution of catastrophizing to disability and pain intensity after osteoporotic vertebral compression fracture. METHOD: We analyzed 35 patients with acute single-level osteoporotic vertebral compression fractures within 3 days of trauma. Data on demographics, education level, Charlson comorbidity index, pain catastrophizing scale (PCS) score, visual analog scale (VAS) score for back pain, and Oswestry Disability Index (ODI) were collected. VAS score for back pain and ODI were assessed at enrollment as well as at 2, 6, and 12 weeks after fracture. RESULTS: Each VAS score for back pain and ODI significantly improved compared to the initial values (P < 0.001). Among the independent variables, age and/or PCS score significantly correlated with VAS score for back pain and/or ODI over follow-up assessments. Hierarchical regression analysis finally showed that PCS score was a significant predictor for disability only in the acute period such as immediately and 2 weeks after fracture, whereas age was significantly associated with ODI at 6 and 12 weeks after fracture. CONCLUSIONS: The present study shows that catastrophizing can contribute to disability only in the acute period after osteoporotic vertebral compression fracture. As the compression fracture heals, however, age is the critical determinant of disability.

Factors affecting postoperative activities of daily living in patients with osteoporotic vertebral collapse with neurological deficits.

Surgical treatment of osteoporotic vertebral collapse (OVC) with neurological deficits presents significant clinical challenges because some patients have fragile bones and often have medical comorbidities, which affect the severity of osteoporosis. We hypothesized that clinical results of surgery in these patients depend on the extent of medical comorbidities that induce secondary osteoporosis. The aim of this study is to examine the effects of medical history and comorbidities on surgical outcomes for these patients, along with the factors that predict postoperative function in activities of daily living (ADL). We retrospectively reviewed data for 88 patients with OVC and neurological deficits who underwent surgery. We assessed clinical results regarding neurological deficits and function in ADL. The presence or absence of comorbidities responsible for secondary osteoporosis and treatments or medical events that affect bone metabolism were examined. We performed statistical analysis to examine prognostic factors for postoperative function in ADL. Of 88 patients, the distributions of comorbidities, treatment, and events in medical history were as follows: hypertension, 57 patients (64.8%); chronic kidney disease (CKD) stage 3 or 4, 32 (36.4%); diabetes mellitus, 16 (18.2%); liver dysfunction, 11 (12.5%); cardiovascular disease, 10 (11.4%); rheumatoid arthritis, 9 (10.2%); and glucocorticoid intake, 8 (9.1%). Twenty-five patients (28.4%) represented poor postoperative ADL (chair-bound or bed-bound), and 11 of 25 patients with poor postoperative ADL represented full neurological recovery. Multivariate analysis revealed decreased estimated glomerular filtration rate (odds ratio 0.96; 95% confidence interval 0.93-0.99; p = 0.005) and a high serum alkaline phosphatase (ALP) level (odds ratio 1.01; 95% CI 1.00-1.02; p = 0.01) were strong predictive factors for poor postoperative function in ADL. The majority of patients with poor postoperative function in ADL had advanced CKD with a disorder of bone metabolism as well as bone fragility.

Back pain-related disability and quality of life in patients affected by vertebral fractures: data from baseline characteristics of population enrolled in Denosumab In Real Practice (DIRP).

BACKGROUND: Spine fragility fractures lead to a significant acute and/or chronic pain and worsening of quality of life. Denosumab is effective in reducing the risk of new vertebral fractures, but its effectiveness on pain relief and improvement of the quality of life in patients with spine fractures are not well known. AIM: The aim of this paper is to describe the baseline demographic and clinical characteristics, back pain-related disability and quality of life of the Denosumab In Real Practice (DIRP) study population. METHODS: DIRP is a multicenter prospective observational study evaluating the effectiveness of denosumab in reducing back pain-related disability and Health-Related Quality of Life (HRQoL) of women with postmenopausal osteoporosis who had already experienced at least one vertebral fragility fracture. Our evaluation protocol includes history of fractures, Spine Pain Index (SPI), HRQoL, bone mineral density (BMD) and radiological assessment of vertebral fragility fractures. RESULTS: Two hundred and twenty-three post-menopausal women, who received a prescription for denosumab, were enrolled. The mean SPI score was 58.6 ± 21.4 SD, and 187 (83.86%) women experienced a moderate-severe pain. The mean HRQoL health state value was 0.54 ± 0.27 SD using EQ-5D index, whereas the mean Physical and Mental Health Composite Scale scores derived from the SF-12 were 31.06 ± 7.77 SD and 39.20 ± 11.03 SD. DISCUSSION AND CONCLUSIONS: Baseline characteristics of DIRP study cohort indicate that patients who received a prescription of denosumab in Campania region are affected by severe osteoporosis with highly prevalent vertebral fractures, disabling back pain and poor health-related quality of life. This is in contradiction with what it is expected by a front-line drug for osteoporosis.

Unilateral or bilateral percutaneous vertebroplasty for acute osteoporotic vertebral fracture: a prospective study.

BACKGROUND: Percutaneous vertebroplasty (PVP) has been demonstrated to be effective in the treatment of acute osteoporotic vertebral fracture (AOVF). However, the matter of which surgical approach should be selected remains controversial. This research aims to compare the clinical results of unilateral and bilateral PVP for AOVF. METHODS: From January 2008 to December 2011, 68 patients with AOVF were randomly assigned to the unilateral puncture group (n=36) or the bilateral group (n=32). These patients underwent percutaneous injection of polymethyl methacrylate into posterior pedicle by the unilateral or bilateral puncture approach. Visual analogue scale (VAS) and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) were recorded on presentation, at 1 week, 3, 6, and 12 months after operation. The cement leakage was measured by x-ray and computed tomography scan. RESULTS: Follow-up data showed there were no significant differences in VAS and QUALEFFO between 2 groups at 1 week after PVP and only significant difference was observed between 2 groups at 3, 6, and 12 months after operation. The cement leakage was 52.7% in the unilateral puncture group and 28.1% in the bilateral group. CONCLUSIONS: Compared with unilateral puncture, use of bilateral approach during PVP may result in more superior long-term outcomes and less cement leakage for patients with AOVF.

Fear of falling, fracture history, and comorbidities are associated with health-related quality of life among European and US women with osteoporosis in a large international study.

UNLABELLED: We studied 7,897 women with postmenopausal osteoporosis to assess factors that influence health-related quality of life (HRQoL). An increased number of comorbidities, fear of falling, and previous vertebral fracture were associated with significant reductions in HRQoL. Understanding the factors that affect HRQoL may improve management of these patients. INTRODUCTION: HRQoL is impaired in women treated for postmenopausal osteoporosis (PMO). The objective of this study was to examine the relationship between clinical characteristics, comorbidities, medical history, patient demographics, and HRQoL in women with PMO. METHODS: Baseline data were obtained and combined from two large and similar multinational observational studies: Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) and in the US (POSSIBLE US™) including postmenopausal women in primary care settings initiating or switching bone loss treatment, or who had been on bone loss treatment for some time. HRQoL measured by health utility scores (EQ-5D™) were available for 7,897 women (94 % of study participants). The relationship between HRQoL and baseline clinical characteristics, medical history and patient demographics was assessed using parsimonious, multivariable, mixed-model analyses. RESULTS: Median health utility score was 0.80 (interquartile range 0.69-1.00). In multivariable analyses, young age, low body mass index, previous vertebral fracture, increased number of comorbidities, high fear of falling, and depression were associated with reduced HRQoL. Regression-based model estimates showed that previous vertebral fracture was associated with lower health utility scores by 0.08 (10.3 %) and demonstrated the impact of multiple comorbidities and of fear of falling on HRQoL. CONCLUSIONS: In this large observational study of women with PMO, there was substantial interindividual variability in HRQoL. An increased number of comorbidities, fear of falling, and previous vertebral fracture were associated with significant reductions in HRQoL.

Vertebral fractures and self-perceived health in elderly women and men in a population-based cross-sectional study: the Tromsø Study 2007-08.

BACKGROUND: Health-related quality of life (HRQL) may be associated with increased mortality in the elderly. The effect of prevalent vertebral fractures on HRQL in elderly women and men is not well described. The purpose of this study was to examine the association between prevalent vertebral fractures and back pain, neck pain, and HRQL in elderly women and men, and to study possible gender differences in the reported pain and HRQL. METHODS: Information on prevalent vertebral fractures was ascertained by a vertebral fracture assessment (VFA) method (dual-energy X-ray absorptiometry (DXA), GE Lunar Prodigy) in 2887 women and men, mean age 65.4 (SD 9.4) who participated in the population-based Tromsø Study which was conducted in 2007-08. Bone mineral density (BMD; g/cm2) was measured by DXA at the femoral sites. Self-reported HRQL was assessed using the standardized measures EQ-5D-3 L and EQ VAS from the EuroQol Group. Lifestyle information was collected by questionnaires. The association between vertebral fractures and pain was analyzed using logistic regression, between vertebral fractures and EQ-5D-3 L and EQ VAS scores by multiple regression analyses. RESULTS: In women, presence of vertebral fractures was associated with an increased risk of back pain with an OR of 1.76 (95% CI: 1.24 - 2.50) after adjustments for age, height, weight, and BMD. Women with vertebral fractures had lower EQ-5D-3 L scores (p < 0.001) than women without vertebral fractures, also after adjustments. These associations were not present in men. Type of fracture was not associated with EQ-5D-3 L scores, but increasing numbers (p < 0.001) and severity of fractures (p < 0.002) were associated with decreasing EQ-5D-3 L score in women. CONCLUSION: Prevalent vertebral fractures are associated with increased risk of back pain and reduced HRQL in postmenopausal women, but not in men.

Association of clinical parameters of operatively treated thoracolumbar fractures with quality of life parameters.

PURPOSE: The intention of the current work was to assess the association between clinical parameters and seven different quality of life (QoL) instruments after surgical treatment of thoracolumbar spinal fractures after an average follow-up of 4.2 years. METHODS: The following human-related quality of life and PRO measures of 66 patients were correlated to clinical parameters such as fingertip-to-floor distance (FFD), Schober measurement, pressure and percussion pain in the lumbopelvine area (PPP), and paravertebral muscle tension: reALOS, SF-36, VAS, VAS spine score, BDI, the GBB-24, and the IES-R. RESULTS: Overall, there was a significant association between the clinical parameters of the thoracolumbar spine such as PPP, paravertebral muscle tension, FFD and Schober's sign on one side, and the seven tested instruments on the other side. CONCLUSIONS: PPP and FFD as well as a small Schober measurement are clinical parameters which significantly influence QoL after surgical treatment of thoracolumbar fractures.

Validation of an osteoporosis self-assessment tool to identify primary osteoporosis and new osteoporotic vertebral fractures in postmenopausal Chinese women in Beijing.

BACKGROUND: This study aimed to validate the effectiveness of the Osteoporosis Self-assessment Tool for Asians (OSTA) in identifying postmenopausal women at increased risk of primary osteoporosis and painful new osteoporotic vertebral fractures in a large selected Han Chinese population in Beijing. METHODS: We assessed the performance of the OSTA in 1201 women. Subjects with an OSTA index > -1 were classified as the low risk group, and those with an index ≤ -1 were classified as the increased risk group. Osteoporosis is defined by a T-score ≤ 2.5 standard deviations according to the WHO criteria. All painful, new vertebral fractures were identified by X-ray and MRI scans with correlating clinical signs and symptoms. We determined the sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve for correctly selecting women with osteoporosis and painful new vertebral fractures. RESULTS: Of the study subjects, 29.3% had osteoporosis, and the prevalence of osteoporosis increased progressively with age. The areas under the ROC curves of the OSTA index (cutoff = -1) to identify osteoporosis in the femoral neck, total hip, and lumbar spine were 0.824, 0.824, and 0.776, respectively. The sensitivity and specificity of the OSTA index (cutoff = -1) to identify osteoporosis in healthy women were 66% and 76%, respectively. With regard to painful new vertebral fractures, the area under the ROC curve relating the OSTA index (cutoff = -1) to new vertebral fractures was 0.812. CONCLUSIONS: The OSTA may be a simple and effective tool for identifying the risk of osteoporosis and new painful osteoporotic vertebral fractures in Han Chinese women.

Impact of clinical fractures on health-related quality of life is dependent on time of assessment since fracture: results from the FREEDOM trial.

UNLABELLED: In the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study, women with incident clinical fractures reported significant declines in health-related quality of life (HRQoL). The largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain. INTRODUCTION: In the FREEDOM trial, denosumab significantly reduced the risk of new vertebral, hip, and nonvertebral fractures. We evaluated the effect of denosumab on HRQoL and the association between incident clinical fractures and HRQoL. METHODS: The FREEDOM trial enrolled 7,868 women aged 60-90 years with a total hip and/or lumbar spine BMD T-score <-2.5 and not <-4.0 at either site. Women were randomized to receive denosumab 60 mg or placebo every 6 months, in addition to daily calcium and vitamin D. HRQoL was assessed with the Osteoporosis Assessment Questionnaire-Short Version (OPAQ-SV) at baseline and every 6 months for 36 months. The OPAQ-SV assesses physical function, emotional status, and back pain. Higher scores indicate better health status. RESULTS: No statistically significant differences in mean change in HRQoL from baseline to end of study were found when comparing treatment groups. Compared with women without any incident fractures during the study, women with incident clinical fractures reported significant declines in physical function (-4.0 vs. -0.5) and emotional status (-5.0 vs. -0.8) at month 36 (P < 0.001 for both). Importantly, time-dependent covariate analyses demonstrated that the largest declines were observed when the assessment was <3 months post fracture. The largest impact of incident clinical fractures was on physical function, and that of incident clinical vertebral fractures was on back pain. CONCLUSIONS: These findings not only demonstrate that incident clinical fractures impact HRQoL but also contribute new information regarding the impact of these fracture events on HRQoL over time.

Effect of vertebral fractures on function, quality of life and hospitalisation the AGES-Reykjavik study.

BACKGROUND: understanding the determinants of health burden after a fracture in ageing populations is important. OBJECTIVE: assess the effect of clinical vertebral and other osteoporotic fractures on function and the subsequent risk of hospitalisation. DESIGN: individuals from the prospective population-based cohort study Age, Gene/Environment Susceptibility (AGES)-Reykjavik study were examined between 2002 and 2006 and followed up for 5.4 years. SUBJECTS: a total of 5,764 individuals, 57.7% women, born 1907-35, mean age 77. METHOD: four groups with a verified fracture status were used; vertebral fractures, other osteoporotic fractures excluding vertebral, non-osteoporotic fractures and not-fractured were compared and analysed for the effect on mobility, strength, QoL, ADL, co-morbidity and hospitalisation. RESULTS: worst performance on functional tests was in the vertebral fracture group for women (P < 0.0001) and the other osteoporotic fractures group for men (P < 0.05). Both vertebral and other osteoporotic fractures, showed an increased risk of hospitalisation, HR = 1.4 (95% CI: 1.3-1.7) and 1.2 (95% CI: 1.1-1.2) respectively (P < 0.0001). Individuals with vertebral fractures had 50% (P < 0.0001) longer hospitalisation than not-fractured and 33% (P < 0.002) longer than the other osteoporotic fractures group. CONCLUSION: individuals with a history of clinical vertebral fracture seem to carry the greatest health burden compared with other fracture groups, emphasising the attention which should be given to those individuals.