Clinical and biological parameters associated with fracture recurrence according to fracture liaison service dataset.

This study describes the characteristics of 337 patients seen by the fracture liaison service of the Amiens University Hospital for at least two osteoporotic fractures between 2009 and 2019. Results showed that recurrent fracture occurs rapidly after the index fracture. Rheumatological and therapeutic managements are not sufficient, mainly because of cognitive disorders or patients' refusal. PURPOSE: The aim of this study was to describe the characteristics of patients taken in charge by a fracture liaison service and sustaining a recurrent osteoporotic fracture. METHODS: This was a retrospective and monocentric study based on the dataset of patients included in the FLS of the Department of Rheumatology of the Amiens University Hospital. To be included in the study cohort, patients must have had at least two consecutive osteoporotic fractures between January 2009 and December 2019. RESULTS: Three hundred thirty-seven patients were included. The mean age at index fracture was 77.3 ± 12.5 years. Eighty-four percent of the patients were women. 89.3% of the patients had a Charlson comorbidity index between 1 and 4. Nearly half of the patients had cognitive disorders. Femoral neck was the most frequent site for both index and recurrent fractures. Thirty-seven percent of patients benefited from a consultation in Rheumatology after their index fracture. The main reasons for the lack of follow-up were cognitive disorders and patient rejection. CONCLUSION: Our study showed that recurrent fracture occurs rapidly after the index fracture and that rheumatological and therapeutic managements are not sufficient, mainly because of cognitive disorders or patients' refusal impairing the patients to benefit from specialized management.

Current characteristics of a population of psoriatic arthritis and gender disparities.

Background and Aim: Psoriatic arthritis (PsA) is a polymorphic disease associated with numerous comorbidities. The objective of this study was to describe the main clinicobiological and imaging characteristics of a population of PsA and to extract any disparities between men and women. Methods: A total of 132 patients in the rheumatology department of Amiens University Hospital with a confirmed diagnosis of PsA according to the CASPAR criteria were included over a period of 4 months. All data were collected retrospectively in this observational and single-center study. Results: The sex ratio was 1 and the average age at inclusion was 54.9 years. Peripheral PsA was the predominant clinical form. Axial PsA represented 12.1% of cases. Enthesitis was noted in 52.3% of cases while dactylitis was identified in 29.5% of cases. Moreover, 12.1% had a joint symptomatology preceding the appearance of cutaneous signs. HLA-B*27 positivity was found in 33.3% of cases. Chronic hyperuricemia accounted for 10% of our population. Sacroiliitis was observed in 41% of cases. The disparities between men and women are multiple and consistent with the literature: Polyarticular form, enthesitis, obesity, more intensive prescription of s-DMARDs, and b-DMARDs are more associated with the female population. Oligoarticular form, psoriatic nail dystrophy, radiological axial involvement, and chronic hyperuricemia are more encountered in the male population. Conclusions: Our study found a very heterogeneous disease, with marked differences between men and women. Peripheral PsA remains predominant but the search for associated axial involvement, which is probably underestimated, seems essential. Relevance for Patients: This work studied the main characteristics of patients with PsA followed in real life, in a regional university reference center. We have highlighted a very heterogeneous disease as well as some gender disparities, not well described in the literature, which should be taken into account in order to optimize therapeutic management.

Effectiveness of fracture liaison services in osteoporosis.

BACKGROUND: In response to the gradual decline in the number of prescriptions for anti-osteoporosis medication (AOM) following fragility fractures, fracture liaison services (FLSs) have been set up around the world with the aim of filling this treatment gap. Several studies have already reported the benefits of such organizations, particularly in reducing fracture risk, mortality rates and healthcare costs, and literature on FLSs has increased at a steady pace over time. METHODS: A narrative review was conducted on the latest available findings on the effectiveness of FLSs. Various approaches to implementing an effective FLS program are discussed. RESULTS: FLS programs have enhanced the management of osteoporosis-related fractures. However, several studies have highlighted that not all FLSs are necessarily effective in reducing subsequent fracture risk and mortality. Long-term AOM persistence and monitoring are another critical issue in FLS programs. A few studies have reported that FLSs are associated with an improvement in AOM persistence, regardless of the type of AOM. Practitioners in the FLS setting need to be aware of the impact of recency of fracture and fracture recurrence rates, and the need for timely interventions. The administration of zoledronic acid in an in-patient setting may improve AOM treatment rates in patients, who often encounter obstacles to outpatient follow-up. Introducing 'vertebral fracture identification services' in FLS programs is also an option. However, doing so leads to an increase in workload and this would need to be considered by any FLS that is considering introducing such a service. Evidence suggests that digital technologies can support (i) multidisciplinary teams in providing the best possible patient care based on current evidence, and (ii) patient self-management. However, as the methodological quality of many of the studies evaluating these technologies was poor, their validity of their results is limited. CONCLUSION: Further research should focus on the optimal implementation of post-fracture care using automated systems, and standardized reporting of patient's characteristics and outcome measures using key performance indicators.

Dietary recommendations in the prevention and treatment of osteoporosis.

INTRODUCTION: This article presents the initial recommendations of the French Rheumatology Society (Société Française de Rhumatologie - SFR) and the Osteoporosis Research and Information Group (Groupe de Recherche et d'Informations sur les Ostéoporoses - GRIO) on the role of diet in the prevention and treatment of osteoporosis. METHODS: The recommendations were produced by a working group composed of rheumatologists, physician nutrition specialists and a geriatrician. Fifteen (15) questions pertaining to "daily practices" were preselected by the working group. For the literature review, the working group focussed mainly on the effects of diet on bone mineral density (BMD) and fractures, and primarily on meta-analyses of longitudinal studies and dietary intervention studies. RESULTS: A Mediterranean-type diet and the daily consumption of 2 to 3 dairy products are recommended. Together, these provide the calcium and "high quality" protein required to maintain a normal calcium-phosphorus balance and bone metabolism, and are associated with lower fracture risk. Conversely, unbalanced Western diets, vegan diets, weight-loss diets in non-overweight individuals, alcohol consumption and daily consumption of sodas are advised against. In terms of the beneficial effects on bone mineral density and fracture risk, current scientific data are either insufficient or too divergent to recommend increasing or restricting the consumption of tea or coffee, vitamins other than vitamin D, vitamin D-enriched or phytoestrogen-rich foods, calcium-enriched plant-based beverages, oral nutritional supplements, or dietary sources of prebiotics and probiotics. CONCLUSIONS: These are the first set of recommendations addressing the role of diet in the prevention and treatment of osteoporosis. More research is necessary to direct and support guidelines.

Comparison of Rheumatoid Arthritis Patients' 2-Year Infliximab, Abatacept, and Tocilizumab Persistence Rates.

Background: Drug persistence reflects an agent's efficacy and safety in routine practice. This study was undertaken to compare the 2-year persistence rates of three biologic disease-modifying antirheumatic drugs (bDMARDs) used to treat rheumatoid arthritis (RA) and to describe their efficacy and safety profiles. Methods: This retrospective, observational, single-center study included RA patients who had received at least one intravenous dose of infliximab, abatacept, and/or tocilizumab. Two-year drug persistence was estimated using the Kaplan−Meier method. Efficacy profiles were assessed as changes of Disease-Activity Score-28 (DAS28)-based EULAR-criteria responses. Results: The infliximab, abatacept, and tocilizumab groups included 40, 72, and 93 patients, respectively. Their respective 2-year persistence rates were similar: 55.0%, 45.8%, and 62.4%. Tocilizumab recipients benefited from greater improvement than those given infliximab (p = 0.0005) or abatacept (p < 0.0001). For all groups combined, 93.1% of patients obtained good or moderate EULAR responses. Conclusions: Even if this retrospective work includes different biases (lack of data, recruitment bias, etc.), it highlights that the 2-year persistence rates for infliximab, abatacept, and tocilizumab in daily practice did not differ significantly, thereby confirming the long-term efficacies of these three bDMARDs. However, tocilizumab was associated with more significant DAS28 improvement at 2 years than infliximab and abatacept.

Exploring the treatment gap among patients with osteoporosis-related fractures in France.

The use of anti-osteoporosis treatment following a diagnosis of osteoporosis with fracture or a relevant fragility fracture remains low in France. Initiating an anti-resorptive may reduce the incidence of a subsequent fracture by 60%. PURPOSE: To describe real-world osteoporosis treatment patterns in individuals with a fragility fracture in France and to explore the impact of initiating treatment on the risk of subsequent fracture. METHODS: A retrospective cohort study, using the national French Health Insurance claims database. Males and females 50 years and over, with a hospital discharge diagnosis of osteoporosis with fracture or a relevant fragility fracture between 2011 and 2014, were included and followed until death or the end of 2016, whichever came first. The primary outcome was the proportion of patients receiving anti-osteoporosis treatments prior to and post-index fracture. Change in fracture rates before and after treatment initiation was assessed in an exploratory analysis. RESULTS: A total of 574,133 patients (138,567 males, 435,566 females) had a qualifying index fracture. The proportion of patients receiving any anti-osteoporosis treatment increased pre-index fracture to post-index fracture from 2.2 to 5.6% among males, and from 11.8 to 18.2% among females. Oral bisphosphonates were the most prescribed anti-osteoporosis treatment for both males and females among post-index fractures (60.6% and 68.8% of patients initiating treatment). Following initiation of anti-resorptives, the incidence of subsequent fracture was reduced by 60% (rate ratio (RR): 0.40, 95% confidence interval [CI]: 0.34-0.45). CONCLUSION: Anti-osteoporosis treatment following an index fracture in France remains low. Improved identification and pharmacologic management of patients at risk of fragility fractures are necessary to reduce the risk of subsequent fractures.

Costs of patient management over 18 months following a hip, clinical vertebral, distal forearm, or proximal humerus fragility fracture in France-results from the ICUROS study.

This observational study prospectively assessed direct and indirect costs related to patient management over 18 months following hip, clinical vertebral, humeral, or distal forearm fracture events in France. It appears that their levels were much higher than the previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures. INTRODUCTION: This prospective observational study assessed the costs related to patient management over the 18-month period following the event of a hip, clinical vertebral, humeral, or distal forearm fracture in France. METHODS: Individuals aged ≥ 50 years old with the diagnosis of a fragility fracture in six French University Hospitals were enrolled in the International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS). All resources used over the defined period and related to fracture and the underlying osteoporosis management were collected by questionnaires at baseline, 4 months, 12 months, and 18 months. Information was collected by direct or phone contact completed by patients' records and interviews of partner, family, and general practitioners. Costs were estimated from a societal perspective, including direct and indirect costs. We implemented recursive partitioning analysis (RPA), a statistical learning algorithm to identify predictors of costs. RESULTS: Four hundred thirty-one patients (mean age 72.5 years; 84.6% women) were evaluated. Among them, 17.6% had a prior fracture in the last 5 years. Approximately half of the whole group lived alone in the community, and 56.8% were from a low- or middle-income category. Over the 18-month period of evaluation, total costs (including initial fracture-related and follow-up ones) were 23 926 €, 14 561 €, and 6 905 € for the hip, clinical vertebral, and distal forearm fracture, respectively. Over a year, costs related to a humeral fracture were 10 319 €. The RPA identified mobility impairment prior to fracture as a predictor of increase in costs related to fracture. CONCLUSIONS: Our study for the first time prospectively assessed total costs related to the four main osteoporotic fractures in France. It appears that their levels were much higher than previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures.

Anti-Carbamylated Fibrinogen Antibodies Might Be Associated With a Specific Rheumatoid Phenotype and Include a Subset Recognizing In Vivo Epitopes of Its γ Chain One of Which Is Not Cross Reactive With Anti-Citrullinated Protein Antibodies.

To identify the targets recognized by anti-carbamylated protein antibodies (anti-CarP) in patients with early Rheumatoid Arthritis (RA), to study the cross-reactivity between anti-CarP and anti-citrullinated protein antibodies (ACPA) and to evaluate their prognostic value. 331 patients (184 RA and 147 other rheumatisms) from the Very Early Arthritis (VErA) French cohort were analyzed. We performed mass spectrometry analysis of RA sera displaying anti-CarP activity and epitope mapping of the carbamylated fibrinogen γ chain to identify immunodominant peptides. The specificity of these targets was studied using competition assays with the major antigens recognized by ACPA. The prognostic value of anti-carbamylated fibrinogen IgG antibodies (ACa-Fib IgG) was compared to that of anti-cyclic citrullinated peptide antibodies (anti-CCP) and anti-CarP using an in-house ELISA. Besides the α chain, the γ chain of fibrinogen, particularly one immunodominant epitope that has a specific reactivity, was identified as a circulating carbamylated target in sera. The prevalence of ACa-Fib was 37% at baseline and 10.9% for anti-CCP-negative RA. In anti-CCP-negative patients, ACa-Fib positivity was associated with a more inflammatory and erosive disease at baseline but not with rapid radiological progression, which remains strongly related to anti-CCP antibodies. Fibrinogen seems to be one of the antigens recognized in vivo by the anti-CarP response, particularly 2 epitopes of the γ chain, one of which is not cross reactive with ACPA. This specificity might be associated with a distinct clinical phenotype since ACa-Fib IgG were shown to be linked to systemic inflammation in very early RA but not to rapid radiological progression.

Inadequate response to treatment reveals persistent osteoclast bone resorption in osteoporotic patients.

Several drugs are able to reduce fracture risk in osteoporotic patients. Incident fractures occur despite good adherence to treatment. Inadequate response has been found related to high serum bone biomarkers of bone turnover. We here aimed to analyze bone microarchitecture and cellular profiles of inadequate responders. We retrospectively analyzed bone biopsies from patients with major fractures despite long-term treatment (inadequate responder [IR] n = 31) in comparison to patients with untreated osteoporosis (U-OP, n = 31) and controls without osteoporosis (Ctrl, n = 16). Bone samples were analyzed by histomorphometry and micro-computed tomography. Clinical and bone turnover markers and bone mineral density were assessed. As compared with U-OP patients, IRs were older (mean age 69.7 ± 8.8 vs 63.3 ± 9.3 years, p = 0.007) and had lower mean hip bone mineral density (0.685 ± 0.116 vs 0.786 ± 0.093 g/cm2), p = 0.019 and T-score (-2.3 ± 0.769 vs -1.6 ± 0.900, p = 0.032). BV/TV was lower for IRs than U-OP patients and Ctrls (13.9 ± 3.8% vs 15.2 ± 5.1 and 17.6 ± 5.2%, p = 0.044) as was trabecular thickness (145.6 ± 23.1 vs 160.5 ± 22.7 and 153.7 ± 21.4 µm, p = 0.033). Mean structure model index was lower for IRs than U-OP patients (1.9 ± 0.806 vs 2.4 ± 0.687, p = 0.042) and osteoclast number was higher for IRs than U-OP patients and Ctrls (0.721 ± 0.611 vs 0.394 ± 0.393 and 0.199 ± 0.071 mm-2, p < 0.001). The mean Obl.S/BS was lower for IRs than U-OP patients and Ctrls (1.2 ± 1.3 vs 1.9 ± 1.4 and 3.0 ± 0.638 mm-2, p < 0.0001), and the mean number of labelled surfaces was lower for IRs than U-OP patients (51.6% vs 87%, p = 0.002). Cortical parameters did not significantly differ. We show an imbalance of bone remodeling in favor of bone resorption in IRs. The persistence of high bone resorption suggests insufficient inhibition of bone resorption that could explain the incident fractures with anti-osteoporotic drug use. Adaptation to treatment should be considered to inhibit bone resorption and prevent further fractures.

The clinical and economic burden after an osteoporosis fracture in France: a nationwide population-based study.

Osteoporosis-related fragility fractures increase the risk of subsequent fractures and are associated with substantial morbidity and mortality. Emphasis should be placed on the prevention of recurrent fractures, which will decrease both the clinical burden on patients and the economic burden on the health system. INTRODUCTION: Fragility fractures are associated with increased morbidity and mortality. Quantifying the clinical and economic burden of subsequent fractures following an initial osteoporosis-related fracture is a key to informing public health policies. METHODS: A retrospective cohort study, using the national French health insurance claims database. Males and females ≥ 50 years, with a hospital discharge diagnosis of osteoporosis with fracture or a relevant fragility fracture (hip, vertebrae, femur, pelvis, wrist/hand, forearm, humerus/clavicle) between 2011 and 2014, were included and followed until death or end of 2016, whichever came first. Index fracture was the first qualifying hospitalization; subsequent fractures were defined as those occurring either at a different site from the index fracture or at the same site ≥ 90 days apart. Costs abstracted included hospitalization, external consultation, outpatient visits, and treatment. RESULTS: A total of 544,426 participants (132,148 [24.3%] males and 412,278 [75.7%] females), of whom 16,110 (12.2%) males and 73,538 (17.8%) females had at least one subsequent fracture during follow-up, were included. Incidence of subsequent fracture was highest in the first year following index fracture. During follow-up, 161,179 patients died; mortality was highest among those with a hip fracture at index (29,971 (51.6%) males and 65,254 (39.6%) females). Total mean costs per patient in the year following index fracture were highest for males and females with a hip fracture (€18,585 and €15,754, respectively). CONCLUSION: Subsequent fractures among osteoporotic participants with an initial fracture result in increased clinical mortality and high healthcare resource use. Emphasis should be placed on the prevention of recurrent fractures.

Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study.

INTRODUCTION: Drug retention is particularly relevant to assess long-term treatments. This real-world study mainly aimed to describe 1-year retention rate (RR) of subcutaneously administered tocilizumab (TCZ-SC) in patients with moderate to severe active rheumatoid arthritis (RA). METHODS: This non-interventional, prospective, multicenter study (NCT02608112) was conducted in patients with RA initiating TCZ-SC treatment, with an 18-month follow-up. RR was estimated at month 12 in the overall population and baseline subgroups (combination with a conventional synthetic disease-modifying antirheumatic drug (csDMARD) or not, age, body mass index, methotrexate dose), using the Kaplan-Meier method. Patient compliance to TCZ-SC was described using the 5-item Compliance Questionnaire for Rheumatology (CQR5). RESULTS: At inclusion 75% of the 285 analyzed patients were women, mean RA duration was 9 ± 9 years, previous RA treatments included biological agents (63%) and/or csDMARDs (94%), mean Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) was 4.8 ± 1.2. TCZ-SC RR at month 12 was estimated to be 64% (95% CI 58%-69%) with no statistical differences between subgroups. Clinical results improved with TCZ-SC; the proportion of patients treated with combined glucocorticoids decreased from 49% to 22% at month 12. At each follow-up time, at least 80% of patients were high adherers to TCZ-SC (at least 80% of theoretical injections). Among the 286 patients with at least one TCZ-SC injection, 25 patients (9%) experienced serious adverse events related to TCZ-SC with no differences according to patient age. CONCLUSIONS: This real-world study corroborates the RR at month 12 previously shown in interventional studies on TCZ-SC. Our data suggest there are no differences according to patient's profile (age, BMI), methotrexate doses, and TCZ-SC use. TRIAL REGISTRATION: NCT02608112.

Therapeutic Maintenance of Baricitinib and Tofacitinib in Real Life.

BACKGROUND: Janus kinase inhibitors (JAKis) represent a new alternative to treat rheumatoid arthritis (RA). The objective of this study was to evaluate the effectiveness, tolerance profile, and maintenance of these treatments (tofacitinib and baricitinib) in real life. METHODS: All patients in the rheumatology department of Amiens University Hospital treated by JAKis for RA were included from 1 October 2017 to 20 May 2020. Clinical and biological data were provided retrospectively in this observational and single-center study. We aimed to study the JAKi maintenance rate at 12 months and their clinical and biological safety profiles. RESULTS: Fifty-five patients were included. Drug maintenance at 12 months was 67.6%. Factors associated with poorer maintenance were a higher Charlson comorbidity index (HR 1.311 (1.089-1.579); p = 0.0042), a higher age (HR 1.055 (1.015-1.096); p = 0.0067), and corticosteroids therapy at initiation (HR 2.722 (1.006-7.365); p = 0.0487). The clinical and biological safety profile was generally good. CONCLUSIONS: Our study found that a higher Charlson index, age, and corticosteroids appeared to be associated with the earlier discontinuation of treatment. JAKis had a response and tolerance profile in real life at least equivalent to that of biological disease-modifying antirheumatic drugs (bDMARDs).

Bone Loss, Osteoporosis, and Fractures in Patients with Rheumatoid Arthritis: A Review.

Rheumatoid arthritis (RA) is often characterized by bone loss and fragility fractures and is a frequent comorbidity. Compared with a matched population, RA patients with fractures have more common risk factors of osteoporosis and fragility fractures but also risk factors resulting from the disease itself such as duration, intensity of the inflammation and disability, and cachexia. The inflammatory reaction in the synovium results in the production of numerous cytokines (interleukin-1, interleukin-6, tumor necrosis factor) that activate osteoclasts and mediate cartilage and bone destruction of the joints, but also have a systemic effect leading to generalized bone loss. Regular bone mineral density (BMD) measurement, fracture risk assessment using tools such as the FRAX algorithm, and vertebral fracture assessment (VFA) should be performed for early detection of osteoporosis and accurate treatment in RA patients.

[Osteoporosis diagnosis and screening]. / Diagnostic et dépistage de l'ostéoporose.

Osteoporosis diagnosis and screening. In fact, there are several definitions of osteoporosis according the purpose we have: pathophysiological, diagnosis, therapeutic, but also because of progress in technology. The first definition is based on histology of iliac crest bone biopsy showing the loss of trabecular bone and microarchitectural abnormalities. More useful, a definition based on biphotonic osteodensitometry X (DXA) proposes the threshold of -2.5 T-score as a clinical definition of osteoporosis. A global definition is proposed by NIH, osteoporosis being a general disease of the skeleton associating bone loss and microarchitectural defects leading to an increased risk of fractures. But none of these definitions allows the practitioner to initiate a specific treatment. That is why a diagnosis of osteoporosis can also be established when the risk of fracture is high considering a personal history of fracture and BMD or more precisely calculated using the FRAX tool.

Diagnostic et dépistage de l'ostéoporose. Il existe de fait plusieurs définitions de l'ostéoporose en fonction du but que l'on se propose, explication physiopathologique, utilité diagnostique ou thérapeutique, et aussi du fait de l'évolution des technologies. La définition la plus ancienne est celle de l'histologiste obtenue par ponction-biopsie osseuse autorisant une analyse histomorphométrique, qui permet de quantifier visuellement la diminution du volume trabéculaire osseux et d'observer directement les altérations de la microarchitecture osseuse. Plus clinique et opérationnelle, l'ostéodensitométrie biphotonique par rayons X (DXA) propose le seuil de T-score de -2,5 comme définition densitométrique de l'ostéoporose. Une définition plus générique de la maladie énonce que l'ostéoporose est une maladie généralisée du squelette associant une diminution de la masse osseuse à des altérations de la microarchitecture conduisant à un risque augmenté de fractures. Cependant, cette définition ne permet pas au praticien de prendre une décision thérapeutique car elle ne propose pas de seuil décisionnel. C'est pourquoi le diagnostic d'ostéoporose peut aussi être retenu quand il y a une indication à traiter du fait de l'importance du risque fracturaire qui sera évalué en tenant compte des antécédents de fractures et de la masse osseuse ou calculé plus précisément à partir d'autres facteurs de risque indépendants en utilisant l'outil numérique FRAX.

Vitamin D Supplementation in France in patients with or at risk for osteoporosis: Recent data and new practices.

With intermittent vitamin D supplementation, serum 25-hydroxyvitamin D (25OHD) levels may remain stable only if the dosing interval is shorter than 3 months, the ideal perhaps being about 1 month. Recent data support moderate daily vitamin D doses instead of high intermittent doses, notably in elderly patients prone to falls. The level of evidence is low, however, with no head-to-head comparisons of clinical outcomes such as fractures and falls in groups given identical dosages daily versus intermittently. A challenge to daily vitamin D supplementation in France is the absence of a suitable pharmaceutical formulation. In addition, daily dosing carries a high risk of poor adherence. Until suitable vitamin D3 formulations such as tablets or soft capsules each containing 1000 or 1500 IU become available, we suggest intermittent supplementation according to 2011 GRIO guidelines. Among the available dosages, the lowest should be preferred, with the shortest possible interval, e.g., 50,000 IU monthly rather than 100,000 every two months.

Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.

BACKGROUND: Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. OBJECTIVES: To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. METHODS: Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. RESULTS: 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated. CONCLUSIONS: In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.

Real-world Adherence and Persistence with Bisphosphonate Therapy in Postmenopausal Women: A Systematic Review.

PURPOSE: Bisphosphonate therapy is a well-established and effective treatment for postmenopausal osteoporosis and the prevention of osteoporotic fracture. However, poor adherence to and poor persistence with bisphosphonate therapy may reduce its benefits. Previous studies have documented the poor rates of adherence and persistence among postmenopausal women with osteoporosis. The objective of this systematic literature review was to evaluate adherence, persistence, and the impact of adherence and persistence on fracture risk in postmenopausal women with diagnosed osteoporosis. METHODS: Articles eligible for review included observational studies of the real-world use of bisphosphonates in 23 countries and were identified by using MEDLINE, EMBASE, IMSEAR (Index Medicus for South-East Asia Region), and LILACS (Latin American and Caribbean Health Sciences Database). FINDINGS: We identified and evaluated 10 studies that assessed bisphosphonate adherence by measuring medication possession ratio (MPR), persistence, and/or the impact of adherence and persistence on fracture risk. Mean MPR at 1 year ranged from 54% to 71% in the 3 studies that reported this assessment of adherence, and 40%-85% of patients at 1 year were adherent, defined as an MPR ≥80%, in the 8 studies that reported this end point. At 1 year, rates of persistence ranged from 28% to 74%. Rates of adherence and persistence were highest with agents requiring less frequent administration and typically declined over time. Fracture rates were significantly lower among adherent women with MPRs ≥80% compared with women with MPRs <80%. IMPLICATIONS: Our results show that suboptimal adherence to and persistence with bisphosphonate therapy in postmenopausal women are common and increase the risk of fracture. Additional research is needed to identify and incorporate effective strategies for improving adherence to bisphosphonates in postmenopausal women.