An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: The effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®
Kaufman J.-M.,Ghent University |
Palacios S.,Instituto Palacios |
Silverman S.,Cedars Sinai Medical Center |
Sutradhar S.,Pfizer |
Osteoporosis International | Year: 2013
The relationship between baseline Fracture Risk Assessment Tool (FRAX®) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX). Introduction: To determine whether the FRAX® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® using data from a phase 3 osteoporosis treatment study. Methods: Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX®. Results: HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR = 0.22-0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR = 0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR = 0.38, 0.41, and 0.40, respectively) for ≥20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (≥2.5- ≥ 10.0 %), but not higher (≥12.5 %), and in no subgroups for nonvertebral or all clinical fractures. Conclusion: The antifracture efficacy of BZA increased with increasing baseline FRAX® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents. © 2013 International Osteoporosis Foundation and National Osteoporosis Foundation.
Lima J.E.M.,Federal University of Rio Grande do Sul |
Lima J.E.M.,University Of Passo Fundo |
Palacios S.,Instituto Palacios |
Wender M.C.O.,Federal University of Rio Grande do Sul
The Scientific World Journal | Year: 2012
We present the translation, cultural adaptation and validation of the Cervantes Scale to Brazilian Portuguese. The Cervantes Scale (CS) was originally described in Spanish, and is a tool to measure health-related quality of life in perimenopausal and menopausal women. A cross-sectional study was carried out with 180 women aged 45 to 64 years. In addition to the CS, the following questionnaires were applied: Women's Health Questionnaire (WHQ) and abbreviated version of the World Health Organizations Quality of Life Questionnaire (Abbreviated WHOQOL-bref). In conclusion, the Brazilian Portuguese version of the CS is easy to apply and understand. The evaluation of its psychometric properties was satisfactory, and it can be applied to assess health-related QoL in Brazilian perimenopausal and menopausal women. © 2012 José E. M. Lima et al.
Reginster J.-Y.,University of Liege |
Brandi M.-L.,University of Florence |
Cannata-Andia J.,University of Oviedo |
Cooper C.,University of Southampton |
And 6 more authors.
Osteoporosis International | Year: 2015
Osteoporosis accounts for about 3 % of total European health-care spending. The low proportion of costs for the pharmacological prevention of osteoporotic fracture means that it is highly cost saving, especially in patient with severe osteoporosis or patients who cannot take certain osteoporosis medications due to issues of contraindications or tolerability. Following recent regulatory changes, strontium ranelate is now indicated in patients with severe osteoporosis for whom treatment with other osteoporosis treatments is not possible, and without contraindications including uncontrolled hypertension, established, current or past history of ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. We review here today’s evidence for the safety and efficacy of strontium ranelate. The efficacy of strontium ranelate in patients complying with the new prescribing information (i.e. severe osteoporosis without contraindications) has been explored in a multivariate analysis of clinical trial data, which concluded that the antifracture efficacy of strontium ranelate is maintained in patients with severe osteoporosis without contraindications and also demonstrated how the new target population mitigates risk. Strontium ranelate is therefore an important alternative in today’s management of osteoporosis, with a positive benefit-risk balance, provided that the revised indication and contraindications are followed and cardiovascular risk is monitored. The bone community should be reassured that there remain viable alternatives in patients in whom treatment with other agents is not possible and protection against the debilitating effects of fracture is still feasible in patients with severe osteoporosis. © 2015, International Osteoporosis Foundation and National Osteoporosis Foundation.
Blumel J.E.,University of Chile |
Palacios S.,Instituto Palacios |
Legorreta D.,Amec Foster Wheeler |
Vallejo M.S.,University of Chile |
Sarra S.,University of Chile
Maturitas | Year: 2012
Fibromyalgia syndrome (FMS) is a disorder usually affecting middle aged women, who complain of diffuse musculoskeletal aches, pains or stiffness associated with tiredness, anxiety and poor sleep. Neurotransmission disorders linked both to pain perception as well as mood, sleep and cognition modulation are involved in FMS etiopathogenesys. Treatments that may be effective to decrease pain and fatigue include tricyclic antidepressants, dual reuptake inhibitors of serotonin/noradrenalin and pregabalin. The climacteric syndrome is a set of symptoms caused by the decline of ovarian hormone levels, which alters brain neurotransmission and provokes musculoskeletal pains, mood disorders, poor sleep quality and hot flushes. The hormone therapy reverses those symptoms and its risks are marginal if women's own hormones are used through transdermal route. Some antidepressants may be useful for patients with climacteric symptoms. We have found it surprising the epidemiological, etiopathogenic, symptomatic and therapeutic similarity between FMS and climacteric that could lead us to hypothesize that FMS is a part of the climacteric syndrome. However, the existence of FMS non-climacteric patients points out that hormone deficit is not the only physiopathological mechanism involved in this syndrome's etiopathogenesys. Nevertheless, it is likely that hormone disorders are involved in the symptoms genesis of most middle aged women with FMS. Keeping this in mind, we see the point in considering the use of HT in climacteric patients with FMS. Studies assessing the FMS clinical response to HT in a prospective manner and with the current diagnose criteria are still required. © 2012 Elsevier Ireland Ltd. All rights reserved.
Palacios S.,Instituto Palacios |
Agodoa I.,Amgen Inc. |
Van Den Bergh J.P.,Maastricht University |
Ferreira I.,Amgen |
And 2 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2015
Context: For many patients, adhering to postmenopausal osteoporosis treatment is a challenge. Higher treatment satisfaction is associated with greater persistence with these therapies, which is associated with better outcomes. Objective: This study aimed to evaluate the change in treatment satisfaction in postmenopausal women who were suboptimally adherent to daily or weekly oral bisphosphonates and who transitioned to denosumab vs a monthly oral bisphosphonate. Design and Setting: Pooled data of outpatients from two international, multicenter, randomized, open-label studies were analyzed. Patients: Postmenopausal women (n = 1703) age 55 years or greater with low bone mineral density who were suboptimally adherent with prior oral bisphosphonate therapy, as assessed by the Osteoporosis-Specific Morisky Medication Adherence Scale, were included in the study. Interventions: Patients received denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor-kappa B ligand, 60 mg sc every 6 months vs the oral bisphosphonates ibandronate or risedronate, 150 mg once monthly for 12 months. Main Outcome Measures: Change in treatment satisfaction scores from baseline to months 6 and 12 were measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is a validated tool that measures perception of four domains of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction. Results: Patients in both treatment groups showed improvement from baseline for all four TSQM domains at 6 and 12 months. However, the denosumab group had significantly (all P < .001) greater improvements among all four TSQM domains at 6 and 12 months compared with the oral bisphosphonate group. Conclusions: Women with low adherence to oral bisphosphonates reported greater treatment satisfaction when transitioned to denosumab vs switching to a monthly oral bisphosphonate. Copyright © 2015 by the Endocrine Society.