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Journal ArticleDOI

Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis.

22 Mar 1990-The New England Journal of Medicine (Massachusetts Medical Society)-Vol. 322, Iss: 12, pp 802-809
TL;DR: It is concluded that fluoride therapy increases cancellous but decreases cortical bone mineral density and increases skeletal fragility, and the fluoride-calcium regimen was not effective treatment for postmenopausal osteoporosis.
Abstract: Although fluoride increases bone mass, the newly formed bone may have reduced strength. To assess the effect of fluoride treatment on the fracture rate in osteoporosis, we conducted a four-year prospective clinical trial in 202 postmenopausal women with osteoporosis and vertebral fractures who were randomly assigned to receive sodium fluoride (75 mg per day) or placebo. All received a calcium supplement (1500 mg per day). Sixty-six women in the fluoride group and 69 women in the placebo group completed the trial. As compared with the placebo group, the treatment group had increases in median bone mineral density of 35 percent (P less than 0.0001) in the lumbar spine (predominantly cancellous bone), 12 percent (P less than 0.0001) in the femoral neck, and 10 percent (P less than 0.0001) in the femoral trochanter (sites of mixed cortical and cancellous bone), but the bone mineral density decreased by 4 percent (P less than 0.02) in the shaft of the radius (predominantly cortical bone). The number of new vertebral fractures was similar in the treatment and placebo groups (163 and 136, respectively; P not significant), but the number of nonvertebral fractures was higher in the treatment group (72 vs. 24; P less than 0.01). Fifty-four women in the fluoride group and 24 in the placebo group had side effects sufficiently severe to warrant dose reduction; the major side effects were gastrointestinal symptoms and lower-extremity pain. We conclude that fluoride therapy increases cancellous but decreases cortical bone mineral density and increases skeletal fragility. Thus, under the conditions of this study, the fluoride-calcium regimen was not effective treatment for postmenopausal osteoporosis.
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19 Jun 2004-BMJ
TL;DR: A system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts is developed, and a summary of the approach from the perspective of a guideline user is presented.
Abstract: Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations Systematic and explicit methods of making judgments can reduce errors and improve communication We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts In this article we present a summary of our approach from the perspective of a guideline user Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk It is also important to consider costs (resource utilisation) before making a recommendation Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues

7,608 citations

Journal ArticleDOI
TL;DR: The revised CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Abstract: To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement.

2,444 citations

Journal ArticleDOI
TL;DR: In this paper, the authors present a checklist for clinicians to consider external validity in the design and reporting of RCTs and make recommendations for greater consideration of external validity for clinical trials.

2,156 citations

Journal ArticleDOI
TL;DR: Daily treatment with alendronate progressively increases the bone mass in the spine, hip, and total body and reduces the incidence of vertebral fractures, the progression of vertebra deformities, and height loss in postmenopausal women with osteoporosis.
Abstract: Background Postmenopausal osteoporosis is a serious health problem, and additional treatments are needed. Methods We studied the effects of oral alendronate, an aminobisphosphonate, on bone mineral density and the incidence of fractures and height loss in 994 women with postmenopausal osteoporosis. The women were treated with placebo or alendronate (5 or 10 mg daily for three years, or 20 mg for two years followed by 5 mg for one year); all the women received 500 mg of calcium daily. Bone mineral density was measured by dual-energy x-ray absorptiometry. The occurrence of new vertebral fractures and the progression of vertebral deformities were determined by an analysis of digitized radiographs, and loss of height was determined by sequential height measurements. Results The women receiving alendronate had significant, progressive increases in bone mineral density at all skeletal sites, whereas those receiving placebo had decreases in bone mineral density. At three years, the mean (±SE) differences in bone...

2,150 citations

Journal ArticleDOI
TL;DR: The criteria required for an effective screening strategy for osteoporosis are largely met in Caucasian women as mentioned in this paper, which suggests that it is appropriate to consider targetting of treatment with agents affecting bone metabolism to susceptible individuals.
Abstract: The criteria required for an effective screening strategy for osteoporosis are largely met in Caucasian women. The disease is common and readily diagnosed by the measurement of bone mineral with single- or dual-energy absorptiometry. Such measurements have high specificity but lower sensitivity, so that the value of the technique is greater for those identified as being at higher risk. Against this background there is little evidence that osteoporosis can usefully be tackled by a public health policy to influence risk factors such as smoking, exercise and nutrition. This suggests that it is appropriate to consider targetting of treatment with agents affecting bone metabolism to susceptible individuals. Since the main benefits of the use of hormone replacement therapy (HRT) are probably on cardiovascular morbidity, the major role for selective screening is to direct non-HRT interventions. An appropriate time to consider screening and intervention is at the menopause, but screening at later ages is also worthy of consideration. Since the cost of screening is low and that of bone-active drugs is high, the selective use of screening techniques will improve the cost-benefit ratio of intervention.

1,854 citations

References
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Journal ArticleDOI
TL;DR: This book brings together a number of procedures developed for regression problems in current use and includes material that either has not previously appeared in a textbook or if it has appeared is not generally available.
Abstract: This book brings together a number of procedures developed for regression problems in current use. Since the emphasis is on practical application theoretical results are stated without proofs in many cases. This book provides a standard basic course in multiple linear regression but it also includes material that either has not previously appeared in a textbook or if it has appeared is not generally available. Chapters 1 and 3 together provide a course in fitting a straight line without using matrix algebra at all. If chapter 2 is added the idea of matrix representation of regression problems can be introduced as well. Chapter 4 covers 2 predictor variables and chapter 5 deals with more complicated models. Selecting the best regression equation is discussed in chapter 6. Chapter 7 covers specific problems. Chapters 8 and 9 discuss 1) multiple regression and mathematical model building and 2) multiple regression applied to analysis of variance problems. Chapter 10 contains an introduction to nonlinear estimation. The 2nd edition contains many new regression ideas and techniques. In particular new computational algorithms and new software regression packages have made it very easy to investigate the allequacy of conjectured models with many different techniques.

3,589 citations

Journal ArticleDOI
TL;DR: A recursive approach based on Kalman's work in linear dynamic filtering and prediction is applied, derivable also from the work of Swerling (1959), which provides an example of many other possible uses of recursive techniques in nonlinear estimation and in related areas.
Abstract: SUMMARY A method for estimating the probability of occurrence of an event from dichotomous or polychotomous data is developed, using a recursive approach. The method in the dichotomous case is applied to the data of a 10-year prospective study of coronary disease. Other areas of application are briefly indicated. The purpose of this paper is to develop a method for estimating from dichotomous (quantal) or polychotomous data, the probability of occurrence of an event as a function of a relatively large number of independent variables. A key feature of the method is a recursive approach based on Kalman's work (Kalman, 1960 and unpublished report) in linear dynamic filtering and prediction, derivable also from the work of Swerling (1959), which provides an example of many other possible uses of recursive techniques in nonlinear estimation and in related areas. The problem that motivated the investigation is a central one in the epidemiology of coronary heart disease, and it will be used to fix ideas and illustrate the method. Some indication of the range of applications will be given in the conclusion.

1,662 citations

Journal ArticleDOI
TL;DR: The data suggest the existence of two distinct syndromes: one form, "postmenopausal osteoporosis," is characterized by excessive and disproportionate trabecular bone loss, involves a small subset of women in the early postmenopausal period, and is associated with hip fractures or vertebral fractures or both.
Abstract: We measured bone mineral density (BMD) of the proximal femur, lumbar spine, or both by dual photon absorptiometry in 205 normal volunteers (123 women and 82 men; age range 20 to 92 yr) and in 31 patients with hip fractures (26 women and 5 men; mean age, 78 yr). For normal women, the regression of BMD on age was negative and linear at each site; overall decrease during life was 58% in the femoral neck, 53% in the intertrochanteric region of the femur, and 42% in the lumbar spine. For normal men, the age regression was linear also; the rate of decrease in BMD was two-thirds of that in women for femoral neck and intertrochanteric femur but was only one-fourth of that in women for lumbar spine. This difference may explain why the female/male ratio is 2:1 for hip fractures but 8:1 for vertebral fractures. The standard deviation (Z-score) from the sex-specific age-adjusted normal mean in 26 women with hip fracture averaged -0.31 (P < 0.05) for the femoral neck, -0.53 (P < 0.01) for the intertrochanteric femur, and +0.24 (NS) for the lumbar spine; results were similar for 5 men with hip fractures. By contrast, for 27 additional women, ages 51-65 yr, with only nontraumatic vertebral fractures, the Z-score was -1.92 (P < 0.001) for the lumbar spine. Thus, contrary to the view that osteoporosis is a single age-related entity, our data suggest the existence of two distinct syndromes. One form, "postmenopausal osteoporosis," is characterized by excessive and disproportionate trabecular bone loss, involves a small subset of women in the early postmenopausal period, and is associated mainly with vertebral fractures. The other form, "senile osteoporosis," is characterized by proportionate loss of both cortical and trabecular bone, involves essentially the entire population of aging women and, to a lesser extent, aging men, and is associated with hip fractures or vertebral fractures or both.

755 citations

Journal ArticleDOI
TL;DR: The combination of calcium fluoride, and estrogen was more effective than any other combination and grounds for optimism about the efficacy of combinations of available agents with sodium fluoride for fracture in postmenopausal osteoporosis.
Abstract: We assessed the rates of vertebral fracture in patients with postmenopausal osteoporosis. Forty-five patients were not treated (91 person-years of observation); 59 were treated conventionally, with calcium (alone or combined with estrogen) or vitamin D or both (218 years); and 61 were treated with sodium fluoride combined with conventional therapy (251 years). The fracture rate (per thousand person-years) was 834 in untreated patients, 419 in those given calcium with or without vitamin D, 304 in those given fluoride and calcium with or without vitamin D, 181 in those given estrogen and calcium with or without vitamin D, and 53 in those given fluoride, estrogen, and calcium with or without vitamin D. It was reduced in all treatment groups (P less than 0.001 for calcium and P less than 1 x 10(-6) for other combinations); fluoride (one years of treatment) and estrogen (but not vitamin D) independently reduced the rate from that observed with calcium alone (P less than 0.001). The combination of calcium fluoride, and estrogen was more effective than any other combination (P less than 0.001). These results provide grounds for optimism about the efficacy of combinations of available agents with sodium fluoride for fracture in postmenopausal osteoporosis.

516 citations

Journal ArticleDOI
TL;DR: The serum concentrations of 2 biochemical markers of bone formation, bone Gla-protein (BGP) and bone alkaline phosphatase (BAP), in 164 normal subjects and 164 patients with metabolic bone disorders gave concordant results, however, in patients with glucocorticoid excess.
Abstract: We measured the serum concentrations of 2 biochemical markers of bone formation, bone Gla-protein (BGP) and bone alkaline phosphatase (BAP), in 164 normal subjects and 164 patients with metabolic bone disorders. The data were reported as Z scores (deviation in SDs from the sex-specific age regression in normal subjects). Both serum BGP and BAP distinguished abnormalities well (mean Z scores for BGP and BAP, respectively) and gave concordant results in patients with hypoparathyroidism (−1.7, −1.4), hyperthyroidism (+1.1, +1.8), primary hyperparathyroidism (+3.6, +2.5), acromegaly (+1.2, +2.8), and postmenopausal osteoporosis (+0.4, +1.9). The 2 markers gave discordant results, however, in patients with glucocorticoid excess (−2.4, +0.9), Paget’s disease (+1.8, +41.8), chronic renal failure (+16.3, +0.4), and osteolytic metastases (−1.4, +5.9). These discrepancies may have occurred because srum BGP and BAP concentrations reflect different aspects of osteoblast function or because there are differences in th...

252 citations

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