References of "Kaufman, JM"
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See detailSerum sclerostin levels in men with idiopathic osteoporosis
Lapauw, Bruno; Vandewalle, S.; Taes, Y. et al

in European Journal of Endocrinology (2013), 168(4), 615-620

Objective: Sclerostin inhibits osteoblast differentiation and bone formation. If aberrant sclerostin action is involved in less efficient bone acquisition in men with idiopathic low bone mass, this might ... [more ▼]

Objective: Sclerostin inhibits osteoblast differentiation and bone formation. If aberrant sclerostin action is involved in less efficient bone acquisition in men with idiopathic low bone mass, this might be reflected in higher serum sclerostin levels. Methods: In 116 men with idiopathic osteoporosis (%65 years old), 40 of their sons and healthy controls, areal bone parameters were measured using dual-energy X-ray absorptiometry, and volumetric and geometric bone parameters were measured using peripheral quantitative computed tomography. Serum analytes were measured using immunoassays and estradiol (E2) levels using liquid chromatography–tandem mass spectrometry. Results: Men with idiopathic low bone mass had lower levels of sclerostin than the controls (0.54G 0.17 vs 0.66G0.23 ng/ml; P!0.001). In both groups, sclerostin levels were strongly associated with age; when adjusting for age, no associations with anthropometrics were observed (PO0.14). In multivariate analyses, sclerostin levels displayed a positive association with whole-body bone mineral content (BMC) and areal BMD (aBMD), as well as with trabecular and cortical volumetric bone mineral density (vBMD) at the tibia in the probands. No clear associations were observed in the control group, neither were sclerostin levels associated with BMC at the radius or lumbar spine (all PO0.11). Testosterone, but not E2, was inversely related to sclerostin levels in the probands. No difference in sclerostin levels was found in their sons when compared with their controls. Conclusion: Lower rather than higher serum sclerostin levels in the probands with idiopathic low bone mass suggest that aberrant sclerostin secretion is not involved in the pathogenesis of low bone mass in these subjects. [less ▲]

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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 detailEfficacy of a strontium ranelate 2 G/vitamin D3 1000 UI combination on the correction of vitamin D insufficiency
Rizzoli, R; Dawson-Hughes, B; Kaufman, JM et al

in Osteoporosis International (2012, May), 23(S2), 225

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See detailEfficacy of once-yearly zoledronic acid 5 mg in men with osteoporosis with different levels of serum total testosterone
Boonen, S; Reginster, Jean-Yves ULg; Kaufman, JM et al

in Osteoporosis International (2012, March), 23(S2), 79-80

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See detailCorrection of vitamin D insufficiency with the fixed daily combination strontium ranelate 2 g/vitamin D3 1000 IU over 12 months
Rizzoli, R; Dawson-Hughes, B; Kaufman, JM et al

in Arthritis and Rheumatism (2012), 64(S10), 835

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See detailFrailty and sarcopenia : definitions and outcome parameters
Cooper, C; Dere, W; Evans, W et al

in Osteoporosis International (2012), 23

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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 detailA reappraisal of generic bisphosphonates in osteoporosis.
Kanis, J. A.; Reginster, Jean-Yves ULg; Kaufman, J. M. et al

in Osteoporosis International (2012), 23

The competitive price of generic bisphosphonates has had a marked effect on practice guidelines, but an increasing body of evidence suggests that they have more limited effectiveness than generally ... [more ▼]

The competitive price of generic bisphosphonates has had a marked effect on practice guidelines, but an increasing body of evidence suggests that they have more limited effectiveness than generally assumed. INTRODUCTION: The purpose of this study is to review the impact of generic bisphosphonates on effectiveness in the treatment of osteoporosis. METHODS: This study is a literature review. RESULTS: A substantial body of evidence indicates that many generic formulations of alendronate are more poorly tolerated than the proprietary preparations which results in significantly poorer adherence and thus effectiveness. Poorer effectiveness may result from faster disintegration times of many generics that increase the likelihood of adherence of particulate matter to the oesophageal mucosa. Unfortunately, market authorisation, based on the bioequivalence of generics with a proprietary formulation, does not take into account the potential concerns about safety. The poor adherence of many generic products has implications for guideline development, cost-effectiveness and impact of treatment on the burden of disease. CONCLUSIONS: The impact of generic bisphosphonates requires formal testing to re-evaluate their role in the management of osteoporosis. [less ▲]

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See detailReduction in incidence of vertebral fractures with once yearly zoledronic acid in men with osteoporosis
Boonen, S.; Kaufman, J. M.; Reginster, Jean-Yves ULg et al

in Journal of Bone and Mineral Research (2011), 26(S1), 23

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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 detailTreatment of osteoporosis: recognizing and managing cutaneous adverse reactions and drug-induced hypersensitivity.
Musette, P.; Brandi, M. L.; Cacoub, P. et al

in Osteoporosis International (2010), 21

Cutaneous adverse reactions are reported for many treatments including antiosteoporotic agents. This position paper includes an algorithm for their recognition. With early recognition and proper ... [more ▼]

Cutaneous adverse reactions are reported for many treatments including antiosteoporotic agents. This position paper includes an algorithm for their recognition. With early recognition and proper management, including immediate and permanent withdrawal of the culprit agent, accompanied by hospitalization, rehydration, and systemic corticosteroids, if necessary, the prognosis is good. INTRODUCTION: Cutaneous adverse reactions are reported for many therapeutic agents and observed in between 0% and 8% of treated patients depending on the drug. The antiosteoporotic agents are reputed to be safe in terms of cutaneous effects; however, there have been a number of case reports of cutaneous adverse reactions, which merit consideration. This was the subject of a Working Group meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis in April 2009, to focus on the impact of cutaneous adverse reactions and drug-induced hypersensitivity in the management of postmenopausal osteoporosis. We prepared this position paper following these discussions, and include an algorithm for their recognition. METHODS: We reviewed cutaneous adverse reactions observed with antiosteoporotic agents, including information from case reports, regulatory documents, and pharmacovigilance. RESULTS: The cutaneous adverse reactions range from benign reactions including exanthematous or maculopapular eruption (drug rash), photosensitivity, and urticaria to the severe and potentially life-threatening reactions, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS), Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Review of available evidence shows that cutaneous adverse reactions occur with all commonly used antiosteoporotic agents. Notably, there are reports of SJS and TEN for bisphosphonates, and of DRESS and TEN for strontium ranelate. These severe reactions remain very rare (<1 in 10,000 cases). CONCLUSION: With early recognition and proper management, including immediate and permanent withdrawal of the culprit agent, accompanied by hospitalization and rehydration and systemic corticosteroids if necessary, the prognosis is good. [less ▲]

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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 detailAdherence to treatment of osteoporosis: a need for study
Lekkerkerker, F.; Kanis, J. A.; Alsayed, N. et al

in Osteoporosis International (2007), 18(10), 1311-1317

Adherence to anti-osteoporosis medications is currently low and is associated with poor anti-fracture efficacy. This manuscript reviews the potential design of clinical studies that aim to demonstrate ... [more ▼]

Adherence to anti-osteoporosis medications is currently low and is associated with poor anti-fracture efficacy. This manuscript reviews the potential design of clinical studies that aim to demonstrate improved adherence, with new chemical entities to be used in the management of osteoporosis. Introduction Several medications have been unequivocally shown to decrease fracture rates in clinical trials. However, in real life settings, long-term persistence and compliance to anti-osteoporosis medication is poor, hence decreasing the clinical benefits for patients. Methods An extensive search of Medline from 1985 to 2006 retrieved all trials including the keywords osteoporosis, compliance, persistence or adherence followed by a critical appraisal of the data obtained through a consensus expert meeting. Results The impact of non-adherence on the clinical development of interventions is reviewed, so that clinicians, regulatory agencies and reimbursement agencies might be better informed of the problem, in order to stimulate the necessary research to document adherence. Conclusion Adherence to therapy is a major problem in the treatment of osteoporosis. Both patients and medication factors are involved. Adherence studies are an important aspect of outcomes studies, but study methodologies are not well developed at the moment and should be improved. Performing adherence studies will be stimulated when registration authorities accept the result of these studies and include the relevant information in Sect. 5.1 of the summary of product characteristics. Reimbursement authorities might also consider such studies as important information for decisions on reimbursement. [less ▲]

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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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See detailStrontium ranelate reduces the risk of vertebral and nonvertebral fractures in women eighty years of age and older
Seeman, E.; Vellas, B.; Benhamou, C. L. et al

in Journal of Bone and Mineral Research (2006), 21(7), 1113-1120

Introduction: About 25-30% of the population burden of all fragility fractures in the community arise from women >= 80 years of age, because this population is at high risk for all types of fracture ... [more ▼]

Introduction: About 25-30% of the population burden of all fragility fractures in the community arise from women >= 80 years of age, because this population is at high risk for all types of fracture, particularly nonvertebral fractures. Despite this, evidence that therapies reduce the risk of both vertebral and nonvertebral fractures in this group is lacking. The aim of this study was to determine whether strontium ranelate, an agent that reduces the risk of vertebral and nonvertebral fractures in postmenopausal women > 50 years of age, also reduces fractures in the elderly. Materials and Methods: An analysis based on preplanned pooling of data from two international, phase 111, randomized, placebo-controlled, double-blind studies (the Spinal Osteoporosis, Therapeutic Intervention [SOTI] and TReatment Of Peripheral OSteoporosis [TROPOS]) included 1488 women between 80 and 100 years of age followed for 3 years. Yearly spinal X-rays were performed in 895 patients. Only radiographically confirmed nonvertebral fractures were included. Results: Baseline characteristics did not differ in placebo and treatment arms. In the intent-to-treat analysis, the risk of vertebral, nonvertebral, and clinical (symptomatic vertebral and nonvertebral) fractures was reduced within I year by 59% (p = 0.002), 41% (p = 0.027), and 37% (p = 0.012), respectively. At the end of 3 years, vertebral, nonvertebral, and clinical fracture risks were reduced by 32% (p = 0.013), 31% (p = 0.011), and 22% (p = 0.040), respectively. The medication was well tolerated, and the safety profile was similar to that in younger patients. Conclusions: Treatment with strontium ranelate safely reduces the risk of vertebral and nonvertebral fractures in women with osteoporosis >= 80 years of age. Even in the oldest old, it is not too late to reduce fracture risk. [less ▲]

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See detailStrontium ranelate reduces the risk of vertebral fracture in patients with osteopenia
Seeman, E.; Sawicki, A.; Reginster, Jean-Yves ULg et al

in Osteoporosis International (2006, May), 17(Suppl. 2), 209

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See detailRecommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men
Reginster, Jean-Yves ULg; Abadie, Eric ULg; Delmas, P. et al

in Osteoporosis International (2006), 17(1), 1-7

Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer ... [more ▼]

Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures. [less ▲]

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