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See detailStrontium ranelate treatment prevents health related quality of life impairement in results from the SOTI study
Marquis, P.; De la Loge, C.; Roux, Christian et al

in Osteoporosis International (2002, November), 13(Suppl.3), 11

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See detailDevelopment of the Osteoporosis Risk Assessment by Composite Linear Essay (ORACLE)
Richy, Florent; Uhoda, Emmanuelle ULg; Reginster, Jean-Yves ULg

in Osteoporosis International (2002, November), 13(Suppl.3), 11

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See detailInterest of a prescreening questionnaire to reduce the cost of bone densitometry
Ben Sedrine, Wafa ULg; Broers, P.; Devogelaer, J. P. et al

in Osteoporosis International (2002), 13(5), 434-442

Bone mineral density (BMD) measurement is widely recognized as the best single tool to identify patients with a high lifetime risk of developing an osteoporosis-related fracture. However, the cost/benefit ... [more ▼]

Bone mineral density (BMD) measurement is widely recognized as the best single tool to identify patients with a high lifetime risk of developing an osteoporosis-related fracture. However, the cost/benefit value of screening the whole population has been repeatedly challenged and demonstrated to be rather poor. In many countries, BMD scan is not or no longer reimbursed because of lack of validated criteria to identify patients who should benefit from this procedure. Based on the proposals of a nationwide expert panel, a simple questionnaire identifying historical, clinical and behavioral risk factors for osteoporosis was developed. The aim of this study was to assess the diagnostic accuracy of the proposed criteria; to determine the extent to which this questionnaire could be useful for optimizing the use of densitometry tests; and, more specifically, to estimate the diagnostic costs per osteoporotic or osteopenic patient detected. For this purpose, we applied the questionnaire to 3998 consecutive individuals at least 20 years old, of both genders, either consulting spontaneously or referred for a BMD measurement to an outpatient osteoporosis center. BMD was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and at the hip (both total hip and femoral neck). Diagnostic accuracies were evaluated through measures of sensitivity, specificity, and positive and negative predictive values. After determining a benchmark value for age, different strategies were compared in order to identify the most cost-effective one in terms of cost per patient detected. According to the WHO operational definition of osteoporosis (T-score <-2.5), 31% of the subjects were classified as osteoporotic at one or more of the measured sites. If only patients with at least one of the proposed risk factors had been referred for scans, 33.3% of the BMD measurements would have been avoided. Among those, less than 5% were missclassified as they did have osteoporosis at the total hip and up to 23% at one or more of the considered sites. On the other hand, of the subjects who would be recommended for a densitometry test, only a small fraction were identified correctly (the positive predictive values varied from 11.3% at the total hip to 34.8% at any site). In this first setting, the suggested criteria seem useful chiefly for excluding subjects who do not need a DXA scan rather than selecting osteoporotic patients. When applied only to patients aged 61 years or more, the positive predictive values rose to 15.1% (total hip) and 42.9% (any site), whereas the corresponding negative predictive values were set at 93% and 68.6%. In comparison, with a mass screening scenario the estimated diagnostic costs (costs associated with the DXA procedure) per osteoporotic patient detected at any of the considered sites would be reduced by more than 9% (59.4 instead of 65.3 Euros) if the suggested indications are taken into account for prescreening patients. And when the questionnaire is applied only to women over the age of 60 years these costs would be further reduced to 50.6 Euros, representing a 23% decrease. Then, a prescreening strategy based on these indications concomitantly with an age-selective criterion could represent a promising way toward a more rational use of BMD measurement. [less ▲]

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See detailThe use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis
Delmas, P. D.; Calvo, Gisèle ULg; Boers, M. et al

in Osteoporosis International (2002), 13(1), 1-5

Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral ... [more ▼]

Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral/nonvertebral fractures as the most usual primary endpoint. The use of a placebo in diseases where an active treatment is available has been a matter of debate following the update of the Declaration of Helsinki by the World Medical Association which questioned this trial design. Current regulatory recommendations within the European Union suggest that placebo-controlled trials are still the best option when assessing the efficacy and safety of new drugs intended for the treatment of postmenopausal osteoporosis. This suggestion seems to be in apparent contradiction with the current content of the Declaration of Helsinki. This paper addresses the ethics and feasibility of placebo-controlled trials in the treatment of postmenopausal osteoporosis, in the light of available therapeutic options, and discusses possible alternative approaches in those patients where placebo treatment could be deemed to be unethical. It is concluded that placebo-controlled trials remain the most efficient design to establish the efficacy and safety of a new agent for the treatment of postmenopausal osteoporosis. Such trials are feasible and ethically acceptable in patients with osteoporosis but without prevalent vertebral fractures. Conversely, in patients with prevalent vertebral fractures, placebo-controlled trials are ethically questionable and non-inferiority trials are more appropriate. A relative margin of non inferiority of 20-30% is suggested, to be discussed on a case by case basis. [less ▲]

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See detailBMD and fracture effects of monofluorophosphate (MFP) combined with raloxifene (RLX) as compared to MFP alone in postmenopausal women with low bone mass
Reginster, Jean-Yves ULg; Felsenberg, D.; Gluer, C. C. et al

in Osteoporosis International (2002), 13(S1), 18-19

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See detailComparison of quantitative ultrasound at the heel with a clinical risk factor score for the assessment of postmenopausal osteoporosis
Goemaere, S.; Zmierczak, H.; Lauwerier, D. et al

in Osteoporosis International (2002), 13(S1), 73-74

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See detailUsing the OST index to identify women at risk of osteoporosis : a validation study in Belgium
Ben Sedrine, Wafa ULg; Reginster, Jean-Yves ULg

in Osteoporosis International (2002), 13(S1), 109-110

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See detailPrediction of bone mineral density by estrogens precursors, estradiol, SHBG and BMI in elderly women at risk for osteoporotic fractures
Goemaere, S.; Zmierczak, H.; Van Pottelbergh, I. et al

in Osteoporosis International (2002), 13(S1), 102

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See detailDose-related bone effects of strontium ranelate in postmenopausal women
Meunier, P. J.; Reginster, Jean-Yves ULg

in Osteoporosis International (2002), 13(S1), 153

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See detailThe effect on bone turnover of monofluorophosphate (MFP) combined with raloxifene (RLX) as compared to MFP alone in postmenopausal women with low bone mass
Stepan, J.; Payer, J.; Resch, H. et al

in Osteoporosis International (2002), 13(S1), 54

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See detailA short-term run-in study can significantly contribute to increasing the quality of long-term osteoporosis trials. The strontium-ranelate phase 3 program
Reginster, Jean-Yves ULg; Spector, T.; Badurski, J. et al

in Osteoporosis International (2002), 13(S1), 30

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See detailStrontium ranelate antifracture study program : current data
Reginster, Jean-Yves ULg; Meunier, P. J.

in Osteoporosis International (2002), 13(S1), 153-154

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See detailOnce weekly alendronate produces a greater decrease in bone resorption than daily risedronate
Hosking, D.; Adami, S.; Felsenberg, D. et al

in Osteoporosis International (2002), 13(S1), 18

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See detailCalcium-vitamin D supplementation in clinical trials of osteoporosis should be titrated on the basis of pre-study assessments
Reginster, Jean-Yves ULg; Diez-Perez, A.; Ortolani, S. et al

in Osteoporosis International (2002), 13(S1), 24

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See detailStructure-modifying drugs in osteoarthritis
Reginster, Jean-Yves ULg; Kvasz, Angela ULg

in Osteoporosis International (2002), 13(Suppl. 1), 49-50

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See detailModels for assessing the cost-effectiveness of the treatment and prevention of osteoporosis
Zethraeus, N.; Ben Sedrine, Wafa ULg; Caulin, F. et al

in Osteoporosis International (2002), 13(11), 841-857

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See detailA simple tool to identify asian women at increased risk of osteoporosis.
Koh, L K; Sedrine, W B; Torralba, T P et al

in Osteoporosis International (2001), 12(8), 699-705

Patients with low bone mineral density (BMD) have a high risk of future fractures, and should be actively considered for treatment to reduce their risk. However, BMD measurements are not widely available ... [more ▼]

Patients with low bone mineral density (BMD) have a high risk of future fractures, and should be actively considered for treatment to reduce their risk. However, BMD measurements are not widely available in some communities, because of cost and lack of equipment. Simple questionnaires have been designed to help target high-risk women for BMD measurements, thereby avoiding the cost of measuring women at low risk. However, such tools have previously focused on evaluation of non-Asian women. We collected information about numerous risk factors from postmenopausal Asian women in eight countries in Asia using questionnaires, and evaluated the ability of these risk factors to identify women with osteoporosis as defined by femoral neck BMD T-scores < or =-2.5. Multiple variable regression analysis and item reduction yielded a final tool based on only age and body weight. This risk index had a sensitivity of 91% and specificity of 45%, with an area under the curve of 0.79. Previously published risk indices based on larger numbers of variables performed similarly well in this Asian population. Large differences in risk were identified using our index to create three categories: 61% of the high-risk women had osteoporosis, compared with only 15% and 3% of the intermediate- and low-risk women, respectively. The low-risk group represented 40% of all women, for whom BMD measurements are probably not needed unless important risk factors, such as prior nonviolent fracture or corticosteroid use, are present. An existing population-based sample of postmenopausal Japanese women was used to validate our index. In this sample of Japanese women the sensitivity was 98% and specificity was 29%; the low-risk category, for whom BMD is probably unnecessary, represented 25% of all women. We conclude that our index performed well for classifying the risk of osteoporosis among postmenopausal Asian women and applying it would result in more prudent use of BMD technology. [less ▲]

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