What is the impact on work of osteoporotic fractures in active patients? A retrospective fracture-liaison-service study-Optiwork 1.

PURPOSE: Osteoporotic fractures have economic consequences and can alter the quality of life. Nevertheless, the direct impact on work has been infrequently reported. Our objective was to estimate the proportion of working patients resuming paid employment within the 3 months following an osteoporotic fracture, and to assess the consequences on their productivity and quality of life. METHODS: Patients aged between 45 and 64, screened by the Fracture Liaison Service of Hospital Paris Saint Joseph for a fragility fracture occurring between January 2017 and December 2018, and being paid employees at the time of the fracture, were included retrospectively. Medical data were extracted from electronic medical records. Self-reporting questionnaires concerning work activity and quality of life before and after the fracture were sent by post. RESULTS: Overall, 121 patients were included, with a mean age of 55.8; 82.6% of patients were female. Fracture of the lower extremity of the radius was the most frequent (38.2%), followed by the upper extremity of the humerus (23.1%). After the index fracture, 82.6% of the patients went back to work, including 76.0% within 3 months following the fracture. The median time to return to work was 2.2 months. Moreover, 19.8% of patients required adaptations of their current work. CONCLUSION: Osteoporotic fractures have a direct impact on work activity, causing work stoppages. Productivity at work and quality of life were also impacted. Further studies are needed to confirm these findings.

[Cervicobrachial neuralgia: frequent and sometimes very painful]. / Névralgie cervico-brachiale : fréquente et parfois très douloureuse.

Cervicobrachial neuralgia. Cervicobrachial neuralgia is a common reason of rheumatologist consultation. It can be defined as cervicalgia associated with radicular pain of the upper limb, caused by a nerve compression. The most frequent cause is a soft disc herniation. Gravity signs have to be researched by a methodic physical exam: neurological deficit, medullar compression. Imagery is recommended: X-rays, tomodensitometry and/or MRI of cervical spine. The treatment is a combination of medicinal and non medicinal therapies, and in some cases, a surgical intervention is required.

Névralgie cervico-brachiale. La névralgie cervicobrachiale est un motif de consultation fréquent en rhumatologie. Elle se traduit par une douleur cervicale et du membre supérieur, provoquée par la compression d'une racine nerveuse au niveau du rachis cervical. La cause la plus fréquente de compression radiculaire est l'existence d'une hernie discale cervicale. Les signes de gravité doivent être recherchés par un examen physique rigoureux : déficit sensitivo-moteur sur le territoire radiculaire ou signes de compression médullaire. Les examens d'imagerie sont les radiographies, la tomodensitométrie et/ou l'imagerie par résonance magnétique du rachis cervical. La prise en charge associe traitements médicamenteux et non médicamenteux, et parfois une sanction chirurgicale s'impose.

[Diagnostic brought in lomboradicular pain in the lower limbs]. / Conduite diagnostique devant une lomboradiculalgie des membres inférieurs.

Diagnostic brought in lomboradicular pain in the lower limbs. Lower limbs radicular pain are frequent. Most of them are caused by lumbar disc herniation or osteoarthritis spinal stenosis. Interrogation and clinical examination are the key stages of the diagnosis, allowing to detect signs of gravity and to rule out the differential diagnosis. The progress of radiological technics, in particular the MRI, considerably simplified the diagnostic approach, but require confronting, with a rigorous objectivity, imaging with the clinical data. The diagnostic approach has to answer two questions: does the symptoms correspond to a common lomboradicular pain or to an other explanation, tumoral for example? In case of common lomboradicular pain, is it a disc herniation, osteoarthritis, or lumbar spinal stenosis?

Conduite diagnostique devant une lomboradiculalgie des membres inferieurs. Les lomboradiculalgies des membres inférieurs sont fréquentes. Dans la grande majorité des cas, la cause est d'origine discale (hernie discale) et/ou arthrosique. L'interrogatoire et l'examen clinique sont les étapes clés du diagnostic, permettant également de rechercher des signes de gravité et d'écarter les diagnostics différentiels. Les progrès de l'imagerie, et notamment de l'imagerie par résonance magnétique, ont considérablement simplifié la démarche diagnostique, sous réserve de confronter avec une objectivité rigoureuse les images aux données cliniques. Ainsi, la conduite diagnostique doit permettre de répondre à deux questions : la douleur correspond-elle à une lomboradiculalgie commune (discale et/ou arthrosique) ou est-elle symptomatique d'une autre cause (tumorale par exemple) ? En cas de lomboradiculalgie commune, s'agit-il d'une hernie discale, d'une arthrose, d'un canal lombaire rétréci ?

Serum uric acid and cardiovascular risk: state of the art and perspectives.

Hyperuricaemia is commonly found in subjects with cardiovascular disease, but its role as risk factor is very controversial. Although several studies reported serum uric acid as a marker of an underlying pathophysiological process, other studies hypothesis a potential causal link between serum uric acid and cardiovascular diseases. Some studies suggest that uric acid is biologically active and may have an atherogenesis role in development of cardiovascular diseases, although the mechanisms are not fully understood. Other studies have shown that uric acid can independently predict the development of some cardiovascular risk factors such as hypertension and metabolic syndrome, as well as myocardial infarction and stroke. The relations between serum uric acid and established cardiovascular risk factors are complex, and these latter could be considered as confounding factors. In this report, we review the inextricably link of serum uric acid to known cardiovascular risk factors, and we describe the possible mechanisms and potential causative role between serum uric acid and cardiovascular events in the general population, in subjects with cardiovascular risk factors and in those with pre-existing cardiovascular diseases. Limited information however is available concerning the impact of urate-lowering treatments on cardiovascular events, whereas only a positive therapeutic trial could give definite answers to the difficult problem of causality of uric acid in relation to cardiovascular risk. Thus, it is time to propose the design of a therapeutic trial, integrating cardiologists and rheumatologists, in order to further decrease cardiovascular risk.

Treatment persistence and changes in fracture risk, back pain, and quality of life amongst patients treated with teriparatide in routine clinical care in France: results from the European Forsteo Observational Study.

OBJECTIVES: The European Forsteo Observational Study assessed the clinical fracture incidence, back pain, quality of life (QoL), and treatment persistence amongst post-menopausal women, who were prescribed teriparatide in routine care in eight European countries. We present the results for France, with health-insurance reimbursement criteria channel teriparatide to women with severe disease and limit treatment to 18 months. METHODS: A representative sample of women initiating teriparatide in France was followed in routine care for 36 months. We described patients' characteristics at baseline and persistence to teriparatide (Kaplan-Meier analysis), fracture incidence, back pain, and QoL (EQ-5D) at baseline, 18 and 36 months follow-up (last-observation-carried-forward (LOCF) and mixed-models-for-repeated-measures (MMRM). RESULTS: One hundred and sixteen rheumatologists included 309 patients, of whom 290 (93.9%) had at least one follow-up visit. Women's mean age (standard deviation) was 74.5 years (7.4) and 296 (95.8%) had greater or equal to two vertebral fractures prior to teriparatide initiation. Clinical fracture incidence, mainly vertebral fractures, decreased around 6 months after teriparatide initiation, and was sustained at 36 months (P=0.013) when most patients were treated by anti-resorptives. Back pain and EQ-5D measures improved significantly at 18 and 36 months (P<0.0001) in the LOCF analyses but did not improve in the EQ-5D VAS measure after covariate adjustment in the MMRM model. Median treatment duration was 17.4 months. CONCLUSION: French women initiating teriparatide in routine care had severe osteoporosis and showed good treatment persistence, consistent with France's insurance reimbursement criteria. Improvements in fracture risk and back pain began soon after treatment and was maintained at 36 months follow-up.

Effective osteoporosis treatment with teriparatide is associated with enhanced quality of life in postmenopausal women with osteoporosis: the European Forsteo Observational Study.

BACKGROUND: To describe changes in health-related quality of life (HRQoL) of postmenopausal women with osteoporosis treated with teriparatide for up to 18 months and followed-up for a further 18 months, and to assess the influence of recent prior and incident fractures. METHODS: The European Forsteo Observational Study (EFOS) is an observational, prospective, multinational study measuring HRQoL using the EQ-5D. The primary objective was to assess changes in HRQoL during 36 months in the whole study population. A secondary post-hoc analysis examined fracture impact on HRQoL in four subgroups classified based on recent prior fracture 12 months before baseline and incident clinical fractures during the study. Changes from baseline were analysed using a repeated measures model. RESULTS: Of the 1581 patients, 48.4% had a recent prior fracture and 15.6% of these patients had an incident fracture during follow-up. 10.9% of the 816 patients with no recent prior fracture had an incident fracture. Baseline mean EQ-VAS scores were similar across the subgroups. In the total study cohort (n = 1581), HRQoL (EQ-VAS and EQ-5D index scores) improved significantly from baseline to 18 months and this improvement was maintained over the 18-month post-teriparatide period. Improvements were seen across all five EQ-5D domains during teriparatide treatment that were maintained after teriparatide was discontinued. Subjects with incident clinical fractures had significantly less improvement in EQ-VAS than those without incident fractures. Recent prior fracture did not influence the change in EQ-VAS during treatment. CONCLUSIONS: EFOS is the first longitudinal study in women with severe postmenopausal osteoporosis in the real world setting to show a substantial improvement in HRQoL during teriparatide treatment that was sustained during subsequent treatment with other medications. The increase in HRQoL was lower in the subgroups with incident fracture but was not influenced by recent prior fracture. The results should be interpreted in the context of the design of an observational study.

Effectiveness of Teriparatide in women over 75 years of age with severe osteoporosis: 36-month results from the European Forsteo Observational Study (EFOS).

This predefined analysis of the European Forsteo Observational Study (EFOS) aimed to describe clinical fracture incidence, back pain, and health-related quality of life (HRQoL) during 18 months of teriparatide treatment and 18 months post-teriparatide in the subgroup of 589 postmenopausal women with osteoporosis aged ≥75 years. Data on clinical fractures, back pain (visual analogue scale, VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. A repeated-measures model analyzed changes from baseline in back pain VAS and EQ-VAS. During the 36-month observation period, 87 (14.8 %) women aged ≥75 years sustained a total of 111 new fractures: 37 (33.3 %) vertebral fractures and 74 (66.7 %) nonvertebral fractures. Adjusted odds of fracture was decreased by 80 % in the 30 to <36-month interval compared with the first 6-month interval (P < 0.009). Although the older subgroup had higher back pain scores and poorer HRQoL at baseline than the younger subgroup, both age groups showed significant reductions in back pain and improvements in HRQoL postbaseline. In conclusion, women aged ≥75 years with severe postmenopausal osteoporosis treated with teriparatide in normal clinical practice showed a reduced clinical fracture incidence by 30 months compared with baseline. An improvement in HRQoL and, possibly, an early and significant reduction in back pain were also observed, which lasted for at least 18 months after teriparatide discontinuation when patients were taking other osteoporosis medication. The results should be interpreted in the context of an uncontrolled observational study.

Effectiveness of teriparatide in postmenopausal women with osteoporosis and glucocorticoid use: 3-year results from the EFOS study.

OBJECTIVE: To describe clinical fracture rates, back pain, and health-related quality of life (HRQOL) in postmenopausal women with osteoporosis who are receiving glucocorticoids (GC), during a 36-month study of teriparatide treatment for up to 18 months, with an additional 18-month followup period when patients were receiving other osteoporosis medications. METHODS: A prospective, multinational, observational study. Data for clinical fractures, back pain (by visual analog scale; VAS) and HRQOL (by EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month segments and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed. RESULTS: Of 1581 enrolled women with followup data, 294 (18.6%) had antecedents of GC use. Of these, 49 (16.7%) patients sustained a total of 69 fractures during the 36-month study period. Adjusted odds of fracture were significantly decreased during the last year of followup compared with the first 6 months of teriparatide treatment: an 81% decrease in the 24 to < 30-month period (p < 0.05), and an 89% decrease in the 30 to < 36-month period (p < 0.05). There were significant reductions in back pain and improvements in HRQOL in both groups of GC users and nonusers. CONCLUSION: Postmenopausal women with severe osteoporosis receiving GC, who were treated with teriparatide for up to 18 months, showed a reduced incidence of clinical fractures during the third year while receiving sequential osteoporosis treatments compared with the first 6 months, together with reduced back pain and improved HRQOL. Our results should be interpreted in the context of an uncontrolled observational study in a routine clinical setting.

Cardiac and arterial calcifications and all-cause mortality in the elderly: the PROTEGER Study.

OBJECTIVE: To investigate the association of overall mortality with the presence and extent of cardiovascular calcifications. METHODS: We investigated the association of cardiac (mitral annulus, aortic valve) and arterial calcifications (abdominal aorta, carotid and femoral arteries) by ultrasonography, with all-cause mortality in a population of 331 high-risk elderly subjects (86.8 ± 6.9 years). After a mean follow-up of 378 days, 110 deaths occurred. RESULTS: A simple calcification score, defined by the presence of cardiac and arterial calcifications, was significantly associated with all-cause mortality (HR=1.47, 95% CI: 1.08-1.99), independent of low plasma albumin, increased plasma glucose and creatinine, as well as low diastolic blood pressure. Moreover, arterial calcifications showed negligible prognostic value with a high prevalence >89%, while cardiac calcifications significantly predicted overall mortality (HR=1.92, 95% CI: 1.28-2.87) at a prevalence of 36%. In another Cox regression, mitral annular calcification was proved to be a significant predictor of total mortality (HR=1.61, 95% CI: 1.02-2.54). CONCLUSION: The independent association between the extent of calcification and all-cause mortality is consistently significant in this frail elderly population. Arterial calcification presents a very high prevalence but a low predictive value, whereas in cardiac calcification, prevalence is lower but predictive value is much higher.

Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS).

The European Forsteo Observational Study was designed to examine the effectiveness of teriparatide in postmenopausal women with osteoporosis treated for up to 18 months in normal clinical practice in eight European countries. The incidence of clinical vertebral and nonvertebral fragility fractures, back pain, and health-related quality of life (HRQoL, EQ-5D) were assessed. Spontaneous reports of adverse events were collected. All 1,648 enrolled women were teriparatide treatment-naive, 91.0% of them had previously received other anti-osteoporosis drugs, and 72.8% completed the 18-month study. A total of 168 incident clinical fractures were sustained by 138 (8.8%) women (821 fractures/10,000 patient-years). A 47% decrease in the odds of fracture in the last 6-month period compared to the first 6-month period was observed (P < 0.005). Mean back pain VAS was reduced by 25.8 mm at end point (P < 0.001). Mean change from baseline in EQ-VAS was 13 mm by 18 months. The largest improvements were reported in the EQ-5D subdomains of usual activities and pain/discomfort. There were 365 adverse events spontaneously reported, of which 48.0% were considered related to teriparatide; adverse events were the reason for discontinuation for 79 (5.8%) patients. In conclusion, postmenopausal women with severe osteoporosis who were prescribed teriparatide in standard clinical practice had a significant reduction in the incidence of fragility fractures and a reduction in back pain over an 18-month treatment period. This was associated with a clinically significant improvement in HRQoL. Safety was consistent with current prescribing information. These results should be interpreted in the context of the open-label, noncontrolled design of the study.

Septic arthritis of the hip with Propionibacterium avidum bacteremia after intraarticular treatment for hip osteoarthritis.

Propionibacterium avidum is a Gram-positive, nonsporulating, facultative anaerobe that has a low level of virulence and is rarely pathogenic. This ubiquitous inhabitant of the sebaceous glands and hair follicles can cause acne vulgaris. Very rarely, P. avidum causes systemic infections after invasive procedures, most notably in immunocompromised patients. Two cases of sacroiliitis due to P. avidum have been reported. We report a case of P. avidum arthritis of the hip with severe sepsis that developed in a 78-year-old woman after intraarticular glucocorticoid treatment for hip osteoarthritis. We are unaware of previous reports of P. avidum hip arthritis.

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting.

OBJECTIVE: The European Forsteo Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry. METHODS: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL. RESULTS: The mean (standard deviation [SD]) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T-score was -3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ-5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients. CONCLUSIONS: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.

[Outpatient medication usage during hospitalization]. / Utilisation des médicaments achetés en ville par les patients hospitalisés: quelles mesures correctives proposer?

OBJECTIVE: To study the frequency and circumstances of patients' use of outpatient medications prescribed by their GP during hospitalization and to assess means of reducing this use. METHOD: A prevalence study of medication use was conducted at Saint Joseph's Hospital in Paris. On one day, we used a specific questionnaire to interview 151 patients in 11 different units about the type and amount of medications they had brought with them to the hospital and the type and amount they had used. RESULTS: Overall, 61% had brought their prescription medication with them, and 36% had used some of it, sometimes without informing the medical staff. In 75% of these cases, these drugs were available from the hospital pharmacy. DISCUSSION: Possible corrective steps include both technological improvements (computerized prescription) and organizational measures: systematic inquiry about and consideration of outpatient prescriptions at admission, use of validated prescription/substitution aids (Comedims), and patient information and education about drug substitutions and interactions.

Off-label prescribing in a French hospital.

OBJECTIVE: In contrast to paediatrics patients, data concerning the extent of off-label prescribing for adult patients are limited. The aim of our study was to investigate the frequency of off-label drug use for adult patients in a French general hospital. METHOD: The study was conducted on a Wednesday in November 2004. Prescribing was prospectively assessed on the basis of conformity with the marketing authorizations. RESULTS: A total of 1341 prescriptions for 192 hospitalized patients were analysed. Twenty three per cent of the prescriptions were off-label. Among all patients, 70% received at least one off-label medicine. Most off-label prescriptions were related to an unapproved indication (75%). The main other reasons were dosage (14%) and dosing schedule (9%). Anti-thrombotic and anti-ulcer agents were found on more than 40% of the off-label prescriptions. CONCLUSION: Off-label prescriptions occur frequently in the hospital and often alternatives with the proper marketing authorizations are available. An increased involvement of hospital pharmacists should reduce the incidence of off-label prescribing and thus contribute to patient safety and possibly cost reduction.

Postmenopausal osteoporosis and atheroma.

Epidemiological studies have established a significant association between two major health problems, osteoporosis and atheroma, which is independent from age, gender, and other cardiovascular risk factors. Bone loss and the development of calcific deposits within vessel walls occur concomitantly. Proteins formerly thought to be specific of bone have been identified in atheroma lesions; and associations linking vertebral and proximal femoral fractures to aortic calcifications have been reported. Bone loss may be a marker for the risk of stroke and cardiovascular death. Bone loss may occur as a consequence of ischemia related to vascular disease. Despite numerous published studies, the mechanism underlying the osteoporosis-atheroma association remains controversial. Factors that perpetuate the debate include the often retrospective design of the studies, small sample sizes, and known limitations of absorptiometry as a tool for measuring osteoporosis severity. We reviewed the available clinical, epidemiological, and animal data on the mechanisms underlying the association between osteoporosis and atheroma. The possible effect of osteoporosis medications on the blood vessel wall is discussed. These issues remain a matter of debate, indicating a need for vast prospective studies to look for a causal link between osteoporosis and atheroma. The results of these studies may lead to new treatment strategies.