References of "Reginster, Jean-Yves"
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See detailLoading and skeletal development and maintenance.
Bergmann, P.; Body, J. J.; BOONEN, S. et al

in Journal of Osteoporosis (2010), 2011

Mechanical loading is a major regulator of bone mass and geometry. The osteocytes network is considered the main sensor of loads, through the shear stress generated by strain induced fluid flow in the ... [more ▼]

Mechanical loading is a major regulator of bone mass and geometry. The osteocytes network is considered the main sensor of loads, through the shear stress generated by strain induced fluid flow in the lacuno-canalicular system. Intracellular transduction implies several kinases and phosphorylation of the estrogen receptor. Several extra-cellular mediators, among which NO and prostaglandins are transducing the signal to the effector cells. Disuse results in osteocytes apoptosis and rapid imbalanced bone resorption, leading to severe osteoporosis. Exercising during growth increases peak bone mass, and could be beneficial with regards to osteoporosis later in life, but the gain could be lost if training is abandoned. Exercise programs in adults and seniors have barely significant effects on bone mass and geometry at least at short term. There are few data on a possible additive effect of exercise and drugs in osteoporosis treatment, but disuse could decrease drugs action. Exercise programs proposed for bone health are tedious and compliance is usually low. The most practical advice for patients is to walk a minimum of 30 to 60 minutes per day. Other exercises like swimming or cycling have less effect on bone, but could reduce fracture risk indirectly by maintaining muscle mass and force. [less ▲]

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See detailPrescribed regimen is effective.
Reginster, Jean-Yves ULg; Altman, Roy D; Hochberg, Marc C

in BMJ (Clinical Research ed.) (2010), 341

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See detailPositive impact of compliance to strontium ranelate on the risk of nonvertebral osteoporotic fractures.
Rabenda, Véronique ULg; Reginster, Jean-Yves ULg

in Osteoporosis International (2010), 21(12), 1993-2002

Adherence is now one of the major issues in the management of osteoporosis. This paper relates the relationship existing between adherence to strontium ranelate and the risk of subsequent nonvertebral ... [more ▼]

Adherence is now one of the major issues in the management of osteoporosis. This paper relates the relationship existing between adherence to strontium ranelate and the risk of subsequent nonvertebral fracture among postmenopausal women with osteoporosis. INTRODUCTION: The aim of this study is to investigate compliance to strontium ranelate (SR) therapy and the impact of compliance on the risk of nonvertebral fractures among women with osteoporosis. METHODS: This study was a post-hoc analysis of pooled data from two international, phase III, randomized, placebo-controlled, double-blind studies (the Spinal Osteoporosis Therapeutic Intervention and Treatment Of Peripheral Osteoporosis). A nested case-control study was performed in the strontium ranelate-treated population. Compliance was quantified using the medication possession ratio (MPR). RESULTS: Two hundred eighty-five nonvertebral fracture cases (hip fx n = 70; major nonvertebral fx n = 213) were identified and matched to 1,425 controls. The mean MPR was 86.8% for controls and 82.6% for cases (p < 0.001). Women who were compliant to SR had a 38% reduction in all nonvertebral fractures compared with those who were not (OR = 0.62; 95%CI[0.47-0.81; p < 0.001). Considering hip fractures only, the risk was reduced by 50% for compliant patients compared to noncompliant patients (OR = 0.50; 95%CI[0.28-0.88]; p < 0.05). CONCLUSION: Our analyses emphasize the importance of good compliance to treatment in order to reduce the risk of osteoporotic fractures. In particular, there was a greater reduction in the risk of nonvertebral and hip fractures with increase compliance. [less ▲]

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See detailOvercoming problems with adherence to osteoporosis medication.
Rabenda, Véronique ULg; Reginster, Jean-Yves ULg

in Expert review of pharmacoeconomics & outcomes research (2010), 10(6), 677-89

Nonadherence to pharmacological treatment in osteoporosis is a well-recognized problem. As in other chronic diseases, adherence to osteoporosis treatment is poor, resulting in enormous burden on patients ... [more ▼]

Nonadherence to pharmacological treatment in osteoporosis is a well-recognized problem. As in other chronic diseases, adherence to osteoporosis treatment is poor, resulting in enormous burden on patients and healthcare resources. Most importantly, low adherence rates consistently result in increased rates of fractures. However, it seems that efforts to evaluate and improve rates of both compliance and persistence are increasing. The extension of dosing intervals may be an element, among others, allowing improvements in therapeutic adherence. Improved patient education, enhancing healthcare provider-patients interaction, taking into account patient's preferences and involving them in treatment decisions may improve adherence. [less ▲]

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See detailInterest of lasofoxifene in the treatment of osteoporosis. Evaluation of "Lasofoxifene in postmenopausal women with osteoporosis". N Engl J Med 2010;362:686-96.
Reginster, Jean-Yves ULg

in Expert Opinion on Pharmacotherapy (2010), 11(10), 1773-5

Lasofoxifene, a new selective estrogen receptor modulator (SERM), was investigated to assess its efficacy and safety in the management of postmenopausal osteoporosis. A dose of 0.5 mg/day of lasofoxifene ... [more ▼]

Lasofoxifene, a new selective estrogen receptor modulator (SERM), was investigated to assess its efficacy and safety in the management of postmenopausal osteoporosis. A dose of 0.5 mg/day of lasofoxifene, given to postmenopausal women with osteoporosis, induced a reduction in vertebral fracture rates after 3 years and a reduction, after 5 years, of nonvertebral fractures, estrogen receptor-positive and invasive breast cancers, major coronary heart diseases and strokes. However, this dose was associated with significant side effects including venous thromboembolisms, pulmonary embolisms, leg cramps, hot flushes, uterine polyps, endometrial hypertrophy, arthralgia and vaginal candidiasis. Since no effect was evidenced on hip fractures, the risk-benefit ratio of this new medication, compared with previously marketed SERMs is, at best, uncertain. [less ▲]

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See detailNational implementation of the ESCEO guidance and its consequences
Reginster, Jean-Yves ULg

in Medicographia (2010), 32

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See detailGlucosamine sulphate in the treatment of knee osteoarthritis: cost-effectiveness comparison with paracetamol.
Scholtissen, S.; Bruyère, Olivier ULg; Neuprez, A. et al

in International Journal of Clinical Practice (2010), 64(6), 756-62

INTRODUCTION: The aim of this study was to explore the cost-effectiveness of glucosamine sulphate (GS) compared with paracetamol and placebo (PBO) in the treatment of knee osteoarthritis. For this purpose ... [more ▼]

INTRODUCTION: The aim of this study was to explore the cost-effectiveness of glucosamine sulphate (GS) compared with paracetamol and placebo (PBO) in the treatment of knee osteoarthritis. For this purpose, a 6-month time horizon and a health care perspective was used. MATERIAL AND METHODS: The cost and effectiveness data were derived from Western Ontario and McMaster Universities Osteoarthritis Index data of the Glucosamine Unum In Die (once-a-day) Efficacy trial study by Herrero-Beaumont et al. Clinical effectiveness was converted into utility scores to allow for the computation of cost per quality-adjusted life year (QALY) For the three treatment arms Incremental Cost-Effectiveness Ratio were calculated and statistical uncertainty was explored using a bootstrap simulation. RESULTS: In terms of mean utility score at baseline, 3 and 6 months, no statistically significant difference was observed between the three groups. When considering the mean utility score changes from baseline to 3 and 6 months, no difference was observed in the first case but there was a statistically significant difference from baseline to 6 months with a p-value of 0.047. When comparing GS with paracetamol, the mean baseline incremental cost-effectiveness ratio (ICER) was dominant and the mean ICER after bootstrapping was -1376 euro/QALY indicating dominance (with 79% probability). When comparing GS with PBO, the mean baseline and after bootstrapping ICER were 3617.47 and 4285 euro/QALY, respectively. CONCLUSION: The results of the present cost-effectiveness analysis suggested that GS is a highly cost-effective therapy alternative compared with paracetamol and PBO to treat patients diagnosed with primary knee OA. [less ▲]

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See detailFracture prevention in osteoporosis: assessing risks, providing solutions.
Reginster, Jean-Yves ULg; Brandi, M. L.

in Osteoporosis International (2010), 21 Suppl 2

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See detailRelationship between 3-month changes in biochemical markers of bone remodelling and changes in bone mineral density and fracture incidence in patients treated with strontium ranelate for 3 years.
Bruyère, Olivier ULg; Collette, Julien ULg; Rizzoli, R. et al

in Osteoporosis International (2010), 21

From two randomised controlled trials, it is shown that 3-month changes in biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) were ... [more ▼]

From two randomised controlled trials, it is shown that 3-month changes in biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) were associated with 3-year bone mineral density (BMD) changes, but not fracture incidence in patients treated with strontium ranelate. INTRODUCTION: The purpose of this study was to assess if short-term change in biochemical markers of bone remodelling is associated with long-term BMD change and fracture incidence observed during treatment with strontium ranelate. METHODS: From the SOTI and TROPOS trials, bone-specific alkaline phosphatase (BALP), C-terminal propeptide of type I procollagen (PICP), serum C-terminal telopeptides (S-CTX) and urine N-terminal telopeptides of type I collagen (U-NTX) were assessed at baseline and after 3 months. RESULTS: Two thousand three hundred seventy-three women were included in this study. Multiple regression analysis showed that 3-month changes in PICP and BALP but not s-CTX I nor s-NTX I were significantly (p < 0.001) associated with 3-year BMD changes at the lumbar spine and the femoral neck. Changes in s-CTX I, PICP and BALP were significantly associated with change in total proximal femur BMD. Changes in biochemical markers explain less than 8% of the BMD changes. The 3-month changes in BALP, PICP s-CTX I and s-NTX I were not significantly associated with fracture incidence. CONCLUSIONS: Short-term changes in biochemical markers of bone formation are associated with future BMD changes in patients treated with strontium ranelate, suggesting a bone-forming activity of this treatment, but are not appropriate to monitor the efficacy of strontium ranelate at the individual level. [less ▲]

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See detailThe need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).
Bruyère, Olivier ULg; Kanis, J. A.; Ibar-Abadie, M*-E et al

in Osteoporosis International (2010), 21(5), 713-22

This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. INTRODUCTION: Real or perceived problems in the relationship between ... [more ▼]

This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. INTRODUCTION: Real or perceived problems in the relationship between academics and the industry have been the subject of much recent debate. It has been suggested that academic clinicians should sever all links with the industry-a view that is rarely challenged. METHODS: Academic experts and members of the pharmaceutical industry were invited to an expert consensus meeting to debate this topic. This meeting was organized by the Group for the Respect of Ethics and Excellence in Science. Conflict of interest, competing interest, right and duties of academic scientist, authorship, and staff and student education were discussed. RESULTS: Guidelines for a transparent, ethical, strong, and successful partnership between the academic scientist and the pharmaceutical industry have been provided. CONCLUSIONS: The Group support interactions between the industry and clinicians provided that it is transparent and ethical. [less ▲]

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See detailFive years treatment with strontium ranelate reduces vertebral and nonvertebral fractures and increases the number and quality of remaining life-years in women over 80 years of age.
Seeman, Ego; Boonen, Steven; Borgstrom, Frederik et al

in BONE (2010), 46(4), 1038-42

INTRODUCTION: Longevity has resulted in a greater proportion of the population entering a time of life when increasing bone fragility and falls predispose to fractures, particularly nonvertebral fractures ... [more ▼]

INTRODUCTION: Longevity has resulted in a greater proportion of the population entering a time of life when increasing bone fragility and falls predispose to fractures, particularly nonvertebral fractures. Women over 80 years of age constitute 10% of the population but contribute 30% of all fractures and 60% of all nonvertebral fractures. Despite this, few studies have examined antifracture efficacy of treatments in this high-risk group and none has provided evidence for benefits beyond 3 years. MATERIALS AND METHODS: To determine whether strontium ranelate reduces the risk of vertebral and nonvertebral fractures during 5 years, we analyzed a subgroup of 1489 female patients over 80 years of age (mean 83.5+/-3.0 years) with osteoporosis from the SOTI (spinal osteoporosis therapeutic intervention) and TROPOS (treatment of peripheral osteoporosis) studies randomized to strontium ranelate 2 g/d or placebo. All received a supplement of calcium plus vitamin D. RESULTS: By intention to treat, vertebral fracture risk was reduced by 31% (relative risk, RR=0.69; 95% confidence interval, CI 0.52-0.92), nonvertebral fracture risk by 27% (RR=0.73; 95% CI 0.57-0.95), major nonvertebral fracture risk by 33% (RR=0.67; 95% CI 0.50-0.89) and hip fracture risk by 24% (RR=0.76; 95% CI 0.50-1.15, not significant). Treatment was cost-saving as it decreased cost and increased QALYs and life-years. DISCUSSION: Strontium ranelate safely produced a significant reduction in vertebral and nonvertebral fracture risk during 5 years in postmenopausal women over 80 years of age and was cost saving. [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 detailOsteoporosis and venous thromboembolism: a retrospective cohort study in the UK General Practice Research Database.
Breart, G.; Cooper, C.; Meyer, O. et al

in Osteoporosis International (2010), 21

In a retrospective cohort study using the General Practice Research Database (GPRD), there was a greater association of venous thromboembolism (VTE) in osteoporotic than in non-osteoporotic female ... [more ▼]

In a retrospective cohort study using the General Practice Research Database (GPRD), there was a greater association of venous thromboembolism (VTE) in osteoporotic than in non-osteoporotic female patients. No greater association was shown in treated patients with strontium ranelate or alendronate compared to untreated osteoporotic female patients. INTRODUCTION: We explored the risk of VTE in usual practice in osteoporotic and non-osteoporotic women with and without anti-osteoporotic treatment. METHODS: A retrospective study was conducted using the GPRD in the UK. The cohorts consisted of untreated osteoporotic women (N = 11,546), osteoporotic women treated with alendronate (N = 20,084), or strontium ranelate (N = 2,408), and a sample of non-osteoporotic women (N = 115,009). Cohorts were compared using a Cox proportional hazards regression model. RESULTS: There was a significantly increased relative risk for VTE in untreated osteoporotic women versus non-osteoporotic women (annual incidence 5.6 and 3.2 per 1,000 patient-years, respectively; relative risk 1.75 [95% confidence interval (CI), 1.09-1.84]). Results were confirmed using adjusted models. The annual incidences of VTE in osteoporotic patients treated with strontium ranelate and alendronate were 7.0 and 7.2 per 1,000 patient-years, respectively, with no significant difference between untreated and treated patients whatever the treatment. Adjusted hazard ratios for treated versus untreated osteoporotic women were 1.09 (95% CI, 0.60-2.01) for strontium ranelate and 0.92 (95% CI, 0.63-1.33) for alendronate. CONCLUSION: This study shows a greater association of VTE in osteoporotic compared to non-osteoporotic patients, but does not show any greater association in treated patients with strontium ranelate or alendronate compared to untreated osteoporotic patients. [less ▲]

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See detailPotential Clinical and Economic Impact of Nonadherence with Osteoporosis Medications.
Hiligsmann, Mickaël ULg; Rabenda, Véronique ULg; Gathon, Henry-Jean ULg et al

in Calcified Tissue International (2010), 86

This study aims to estimate the potential clinical and economic implications of therapeutic adherence to bisphosphonate therapy. A validated Markov microsimulation model was used to estimate the impact of ... [more ▼]

This study aims to estimate the potential clinical and economic implications of therapeutic adherence to bisphosphonate therapy. A validated Markov microsimulation model was used to estimate the impact of varying adherence to bisphosphonate therapy on outcomes (the number of fractures and the quality-adjusted life-years [QALYs]), health-care costs, and the cost-effectiveness of therapy compared with no treatment. Adherence was divided into persistence and compliance, and multiple scenarios were considered for both concepts. Analyses were performed for women aged 65 years with a bone mineral density T-score of -2.5. Health outcomes and the cost-effectiveness of therapy improved significantly with increasing compliance and/or persistence. In the case of real-world persistence and with a medical possession ratio (MPR; i.e., the number of doses taken divided by the number of doses prescribed) of 100%, the QALY gain and the number of fractures prevented represented only 48 and 42% of the values estimated assuming full persistence, respectively. These proportions fell to 27 and 23% with an MPR value of 80%. The costs per QALY gained, for branded bisphosphonates (and generic alendronate), were estimated at <euro>19,069 (<euro>4,871), <euro>32,278 (<euro>11,985), and <euro>64,052 (<euro>30,181) for MPR values of 100, 80, and 60%, respectively, assuming real-world persistence. These values were <euro>16,997 (<euro>2,215), <euro>24,401 (<euro>6,179), and <euro>51,750 (<euro>20,569), respectively, assuming full persistence. In conclusion, poor compliance and failure to persist with osteoporosis medications results not only in deteriorating health outcomes, but also in a decreased cost-effectiveness of drug therapy. Adherence therefore remains an important challenge for health-care professionals treating osteoporosis. [less ▲]

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See detailCost-utility of long-term strontium ranelate treatment for postmenopausal osteoporotic women.
Hiligsmann, Mickaël ULg; Bruyère, Olivier ULg; Reginster, Jean-Yves ULg

in Osteoporosis International (2010), 21

The results of this study suggested that long-term treatment with strontium ranelate over 5 years is cost-effective compared to no treatment for postmenopausal osteoporotic women. INTRODUCTION: This study ... [more ▼]

The results of this study suggested that long-term treatment with strontium ranelate over 5 years is cost-effective compared to no treatment for postmenopausal osteoporotic women. INTRODUCTION: This study aims to estimate the cost-effectiveness of long-term strontium ranelate treatment for postmenopausal osteoporotic women. METHODS: A validated Markov microsimulation model with a Belgian healthcare cost perspective was used to assess the cost per quality-adjusted life-year (QALY) of strontium ranelate compared to no treatment, on a basis of calcium/vit D supplementation if needed. Analyses were performed for women aged 70, 75, and 80 years either with a bone mineral density T-score </= -2.5 SD or with prevalent vertebral fractures. The relative risk of fracture during therapy was derived from the Treatment of Peripheral Osteoporosis Study trial over 5 years of treatment. Parameter uncertainty was evaluated using both univariate and probabilistic sensitivity analyses. RESULTS: Strontium ranelate was cost-saving at the age of 80 years in both populations. For women with a T-score </= -2.5 SD, the costs per QALY gained of strontium ranelate were respectively <euro>15,096 and <euro>6,913 at 70 and 75 years of age while these values were <euro>23,426 and <euro>9,698 for women with prevalent vertebral fractures. Sensitivity analyses showed that the results were robust over a wide range of assumptions. CONCLUSION: This study suggested that, compared to no treatment, long-term strontium ranelate treatment is cost-effective for postmenopausal osteoporotic women. [less ▲]

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