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See detailBalancing benefits and risks of glucocorticoids in rheumatic diseases and other inflammatory joint disorders: new insights from emerging data. An expert consensus paper from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)
Cooper, C.; Bardin, T.; Brandi, M.L. et al

in Aging Clinical and Experimental Research (2016), 28(1), 1-16

Purpose: This consensus review article considers the question of whether glucocorticoid (GC) therapy is still relevant in the treatment of rheumatic diseases, with a particular focus on rheumatoid ... [more ▼]

Purpose: This consensus review article considers the question of whether glucocorticoid (GC) therapy is still relevant in the treatment of rheumatic diseases, with a particular focus on rheumatoid arthritis (RA), and whether its side effects can be adequately managed. Recent basic and clinical research on the molecular, cellular and clinical effects of GCs have considerably advanced our knowledge in this field. An overview of the subject seems appropriate. Methods: This review is the result of a multidisciplinary expert working group, organised by European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. The recent literature was surveyed and the salient evidence synthetized. Results: The pathophysiological basis of RA (and other inflammatory rheumatic diseases) now strongly implicates the adaptive immune system in addition to innate mechanisms. The molecular effect of GCs and differential GC sensitivity is better understood, although exploiting this knowledge is still in its infancy. The newer treatment strategies of early and aggressive control of RA have greatly improved clinical outcomes, but improvements are still possible. Newer targeted anti-inflammatory drugs have made an important impact, yet they too are associated with numerous side effects. Discussion: Short durations of moderate doses of GCs are generally well tolerated and have a positive benefit/risk ratio. Patients should be assessed for fracture risk and bone preserving agents and be prescribed calcium and vitamin D supplementation. Conclusions: Within a strategy of a disease modifying approach to inflammatory disease, combination therapy including a GC is effective approach. [less ▲]

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See detailRecommendations for an update of the 2010 European regulatory guideline on clinical investigation of medical products used in the treatment of osteoarthritis and reflections about related clinically relevant outcomes: expert consensus statement.
Reginster, Jean-Yves ULg; REITER-NIESERT, S.; Bruyère, Olivier ULg et al

in Osteoarthritis and Cartilage (2015), 23

Objective: The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on ... [more ▼]

Objective: The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). Design: Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. Results: It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs e i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter e in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). [less ▲]

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See detailCan we identify patients to be treated in osteoarthritis?
Arden, NK; Richette, P; Cooper, C et al

in Osteoporosis International (2015), 26(S1), 61-62

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See detailCan we identify patients with high risk of osteoarthritis progression who will respond to treatment ? A focus on epidemiology and phenotype of osteoarthritis
Bruyère, Olivier ULg; Cooper, C; Arden, N et al

in Drugs & Aging (2015), 32(3), 179-187

Osteoarthritis is a syndrome affecting a variety of patient profiles. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the European Union Geriatric Medicine ... [more ▼]

Osteoarthritis is a syndrome affecting a variety of patient profiles. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the European Union Geriatric Medicine Society working meeting explored the possibility of identifying different patient profiles in osteoarthritis. The risk factors for the development of osteoarthritis include systemic factors (e.g., age, sex, obesity, genetics, race, and bone density) and local biomechanical factors (e.g., obesity, sport, joint injury, and muscle weakness); most also predict disease progression, particularly joint injury, malalignment, and synovitis/effusion. The characterization of patient profiles should help to better orientate research, facilitate trial design, and define which patients are the most likely to benefit from treatment. There are a number of profile candidates. Generalized, polyarticular osteoarthritis and local, monoarticular osteoarthritis appear to be two different profiles; the former is a feature of osteoarthritis comorbid with inflammation or the metabolic syndrome, while the latter is more typical of post-trauma osteoarthritis, especially in cases with severe malalignment. Other biomechanical factors may also define profiles, such as joint malalignment, loss of meniscal function, and ligament injury. Early- and late-stage osteoarthritis appear as separate profiles, notably in terms of treatment response. Finally, there is evidence that there are two separate profiles related to lesions in the subchondral bone, which may determine benefit from bone-active treatments. Decisions on appropriate therapy should be made considering clinical presentation, underlying pathophysiology, and stage of disease. Identification of patient profiles may lead to more personalized healthcare, with more targeted treatment for osteoarthritis. [less ▲]

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See detailStrontium ranelate improves osteoarthritis symptoms compared to placebo in patients with knee OA: The SEKOIA study
Bruyère, Olivier ULg; Richette, P; Bellamy, N et al

in Osteoporosis International (2013, April), 24(Suppl.1), 49-51

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See detailTreatment of osteoporosis in men.
Kaufman, JM; Reginster, Jean-Yves ULg; Boonen, S et al

in BONE (2013), 53(1), 134-44

SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline ... [more ▼]

SUMMARY: Aspects of osteoporosis in men, such as screening and identification strategies, definitions of diagnosis and intervention thresholds, and treatment options (both approved and in the pipeline) are discussed. INTRODUCTION: Awareness of osteoporosis in men is improving, although it remains under-diagnosed and under-treated. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) workshop was convened to discuss osteoporosis in men and to provide a report by a panel of experts (the authors). METHODS: A debate with an expert panel on preselected topics was conducted. RESULTS AND CONCLUSIONS: Although additional fracture data are needed to endorse the clinical care of osteoporosis in men, consensus views were reached on diagnostic criteria and intervention thresholds. Empirical data in men display similarities with data acquired in women, despite pathophysiological differences, which may not be clinically relevant. Men should receive treatment at a similar 10-year fracture probability as in women. The design of mixed studies may reduce the lag between comparable treatments for osteoporosis in women becoming available in men. [less ▲]

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See detailEffects of Strontium ranelate on knee osteoarthritis pain : a responder analysis
Reginster, Jean-Yves ULg; Chapurlat, R; Bellamy, N et al

in Arthritis and Rheumatism (2012), 64(S10), 110

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See detailMaintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
Reginster, Jean-Yves ULg; Kaufman, J. M.; Goemaere, S. et al

in Osteoporosis International (2012), 23

In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and ... [more ▼]

In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term. INTRODUCTION: Strontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years. METHODS: Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX(R) scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX(R)-matched placebo group identified in the TROPOS placebo arm. RESULTS: The patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 +/- 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX(R)-matched placebo group over 5 years (P < 0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years. CONCLUSIONS: Long-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate. [less ▲]

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See detailBisphosphonates and glucocorticoid osteoporosis in men: results of a randomized controlled trial comparing zoledronic acid with risedronate.
Sambrook, P. N.; Roux, C.; Devogelaer, J. P. et al

in BONE (2012), 50

BACKGROUND: We studied 265 men (mean age 56.4years; range 18-83years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate ... [more ▼]

BACKGROUND: We studied 265 men (mean age 56.4years; range 18-83years), among patients enrolled in two arms of a double-blind, 1-year study comparing the effects of zoledronic acid (ZOL) with risedronate (RIS) in patients either commencing (prednisolone 7.5mg/day or equivalent) (prevention arm, n=88) or continuing glucocorticoid therapy (treatment arm, n=177). METHODS: Patients received either a single ZOL 5mg infusion or RIS 5mg oral daily at randomization, along with calcium (1000mg) and vitamin D (400-1200IU). Primary endpoint: difference in percentage change from baseline in bone mineral density (BMD) at the lumbar spine (LS) at 12months. Secondary endpoints: percentage changes in BMD at total hip (TH) and femoral neck (FN), relative changes in bone turnover markers (beta-CTx and P1NP), and overall safety. FINDINGS: In the treatment subpopulation, ZOL increased LS BMD by 4.7% vs. 3.3% for RIS and at TH the percentage changes were 1.8% vs. 0.2%, respectively. In the prevention subpopulation, bone loss was prevented by both treatments. At LS the percentage changes were 2.5% vs. -0.2% for ZOL vs. RIS and at TH the percentage changes were 1.1% vs. -0.4%, respectively. ZOL significantly increased lumbar spine BMD more than RIS at Month 12 in both the prevention population (p=0.0024) and the treatment subpopulation (p=0.0232) in men. In the treatment subpopulation, ZOL demonstrated a significantly greater reduction in serum beta-CTx and P1NP relative to RIS at all time-points. In the prevention subpopulation, ZOL significantly reduced beta-CTx at all time-points, and P1NP at Month 3 (p=0.0297) only. Both treatments were well tolerated in men, albeit with a higher incidence of influenza-like illness and pyrexia events post-infusion with ZOL. INTERPRETATION: Once-yearly ZOL preserves or increases BMD within 1year to a greater extent than daily RIS in men receiving glucocorticoid therapy. [less ▲]

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See detailMaintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis
Reginster, Jean-Yves ULg; Kaufman, J. M.; Devogelaer, J. P. et al

in Arthritis and Rheumatism (2011), 63(S10), 436

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See detailA FRAX(R) model for the assessment of fracture probability in Belgium.
Johansson, H.; Kanis, J. A.; McCloskey, E. V. et al

in Osteoporosis International (2011), 22(2), 453-61

A country-specific FRAX(R) model was developed from the epidemiology of fracture and death in Belgium. Fracture probabilities were identified that corresponded to currently accepted reimbursement ... [more ▼]

A country-specific FRAX(R) model was developed from the epidemiology of fracture and death in Belgium. Fracture probabilities were identified that corresponded to currently accepted reimbursement thresholds. INTRODUCTION: The objective of this study was to evaluate a Belgian version of the WHO fracture risk assessment (FRAX(R)) tool to compute 10-year probabilities of osteoporotic fracture in men and women. A particular aim was to determine fracture probabilities that corresponded to the reimbursement policy for the management of osteoporosis in Belgium and the clinical scenarios that gave equivalent fracture probabilities. METHODS: Fracture probabilities were computed from published data on the fracture and death hazards in Belgium. Probabilities took account of age, sex, the presence of clinical risk factors and femoral neck bone mineral density (BMD). Fracture probabilities were determined that were equivalent to intervention (reimbursement) thresholds currently used in Belgium. RESULTS: Fracture probability increased with age, lower BMI, decreasing BMD T-score and all clinical risk factors used alone or combined. The 10-year probabilities of a major osteoporosis-related fracture that corresponded to current reimbursement guidelines ranged from approximately 7.5% at the age of 50 years to 26% at the age of 80 years where a prior fragility fracture was used as an intervention threshold. For women at the threshold of osteoporosis (femoral neck T-score = -2.5 SD), the respective probabilities ranged from 7.4% to 15%. Several combinations of risk-factor profiles were identified that gave similar or higher fracture probabilities than those currently accepted for reimbursement in Belgium. CONCLUSIONS: The FRAX(R) tool has been used to identify possible thresholds for therapeutic intervention in Belgium, based on equivalence of risk with current guidelines. The FRAX(R) model supports a shift from the current DXA-based intervention strategy, towards a strategy based on fracture probability of a major osteoporotic fracture that in turn may improve identification of patients at increased fracture risk. The approach will need to be supported by health economic analyses. [less ▲]

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See detailEffectiveness of zoledronic acid in the prevention and treatment of glucocorticoid-induced osteoporosis in men and premenopausal women
Saag, k; Roux, C.; Devogelaer, J. P. et al

in Arthritis and Rheumatism (2010, October), 62(10), 902-903

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See detailBisphosphonates and glucocorticoid osteoporosis in men : results of a randomized controlled trial comparing zoledronic acid with risedronate
Sambrook, P. N.; Roux, C.; Devogelaer, J. P. et al

in Osteoporosis International (2010, May), 21(Suppl.1), 19

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See detailEvidence-based guidelines for the pharmacological treatment of postmenopausal osteoporosis: a consensus document by the Belgian Bone Club.
Body, J. J.; Bergmann, P.; Boonen, S. et al

in Osteoporosis International (2010), 21(10), 1657-80

Several drugs are available for the management of postmenopausal osteoporosis. This may, in daily practice, confuse the clinician. This manuscript offers an evidence-based update of previous treatment ... [more ▼]

Several drugs are available for the management of postmenopausal osteoporosis. This may, in daily practice, confuse the clinician. This manuscript offers an evidence-based update of previous treatment guidelines, with a critical assessment of the currently available efficacy data on all new chemical entities which were granted a marketing authorization. Osteoporosis is widely recognized as a major public health concern. The availability of new therapeutic agents makes clinical decision-making in osteoporosis more complex. Nation-specific guidelines are needed to take into consideration the specificities of each and every health care environment. The present manuscript is the result of a National Consensus, based on a systematic review and a critical appraisal of the currently available literature. It offers an evidence-based update of previous treatment guidelines, with the aim of providing clinicians with an unbiased assessment of osteoporosis treatment effect. [less ▲]

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See detailEffect of zoledronic acid (single 5 mg infusion) on lumbar spine bone mineral density versus oral risedronate (5 mg/day) over one year in subgroups of patients receiving glucocorticoid therapy
Roux, C.; Reid, D.; Devogelaer, J. P. et al

in Osteoporosis International (2008), 19(S2), 248-249

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See detailRelationship between bone mineral density changes and fracture risk reduction in patients treated with strontium ranelate
Bruyère, Olivier ULg; Roux, C.; Detilleux, Johann ULg et al

in Journal of Clinical Endocrinology and Metabolism (2007), 92(8), 3076-3081

Objective: Our objective was to analyze the relationship between bone mineral density (BMD) changes and fracture incidence during 3-yr treatment with strontium ranelate. Patients: Women from the strontium ... [more ▼]

Objective: Our objective was to analyze the relationship between bone mineral density (BMD) changes and fracture incidence during 3-yr treatment with strontium ranelate. Patients: Women from the strontium ranelate arm of the Spinal Osteoporosis Therapeutic Intervention study and the TReatment Of Peripheral OSteoporosis study were evaluated. Outcome Measures: The outcome measures included BMD at the lumbar spine, femoral neck, and total proximal femur assessed at baseline and after a follow-up of 1 and 3 yr; semiquantitative visual assessment of vertebral fractures; and nonvertebral fractures based on written documentation. Results: After 3 yr of strontium ranelate treatment, each percentage point increase in femoral neck and total proximal femur BMD was associated with a 3%(95% adjusted confidence interval, 1-5%) and2% (1-4%) reduction in risk of a new vertebral fracture, respectively. The 3- yr changes in femoral neck and total proximal femur BMD explained 76% and 74%, respectively, of the reduction in vertebral fractures observed during the treatment. Three-year changes in spine BMD were not statistically associated with the incidence of new vertebral fracture (P = 0.10). No significant associations were found between 3- yr changes in BMD and incidence of new nonvertebral fractures, but a trend was found for femoral neck BMD (P = 0.09) and for total proximal femur BMD (P = 0.07). An increase in femoral neck BMD after 1 yr was significantly associated with the reduction in incidence of new vertebral fractures observed after 3 yr (P = 0.04). Conclusion: During 3-yr strontium ranelate treatment, an increase in femoral neck BMD was associated with a proportional reduction in vertebral fracture incidence. [less ▲]

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See detailDual energy X-ray absorptiometry-based assessment of male patients using standardized bone density values and a national reference database
Goemaere, S.; Vanderschueren, D.; Kaufman, J. M. et al

in Journal of Clinical Densitometry (2007), 10(1, JAN-MAR), 25-33

Dual energy X-ray absorptiometry (DXA) measurements from different manufacturers provide different bone mineral density (BMD) values and derived T-scores and Z-scores. These differences result partly from ... [more ▼]

Dual energy X-ray absorptiometry (DXA) measurements from different manufacturers provide different bone mineral density (BMD) values and derived T-scores and Z-scores. These differences result partly from technical differences in the algorithms for the determination of bone mineral content and bone area and partly from the use of different manufacturer-derived reference databases. The present study was to implement a uniforrn expression of BNID in all male patients by using standardized BMD (sBMD) values and referring to a newly established national male reference sample. In 8 bone densitometry centers throughout Belgium 229 young healthy men were measured on Hologic (Bedford, MA) or GE-Lunar (Madison, WI) bone densitometers. Quality control procedures were implemented and site cross-calibration performed using the European Spine Phantom. Absolute BMD values were converted to standardized values by validated formulas (sBMD). Clinically acceptable between-center differences were noted. No discrepancy was observed in terms of mean sBMD and standard deviations at the lumbar spine and proximal femur between the Belgian and the US reference populations. Region-specific sBMD thresholds for the diagnosis of male osteoporosis were calculated. The current data provide a basis to implement a nation-wide, uniform expression of BMD in male patients and allow harmonization of the BMD-based diagnosis and treatment of osteoporosis in men. [less ▲]

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