Silvina Levis

University of Miami Miller School of Medicine, Miami, Florida, United States

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Publications (29)126.78 Total impact

  • Stuti Dang, Silvina Levis, Violet S Lagari
    Journal of Women s Health 03/2014; 23(3):278. · 1.42 Impact Factor
  • Violet S Lagari, Silvina Levis
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    ABSTRACT: Postmenopausal osteoporosis is a condition associated with low bone mass resulting from the increased bone resorption that occurs following a decline in estrogen levels. Phytoestrogens are plant-derived compounds that have affinity to the estrogen receptor and are able to act as either estrogen agonists or antagonists. Because of their structural similarity to 17-beta-estradiol, they have been studied extensively for their role in the prevention of postmenopausal bone loss. An extensive number of studies employing different types of isoflavone preparations (including soy foods, soy-enriched foods, and soy isoflavone tablets) have been conducted in a wide range of populations, including Western and Asian women. Although there is considerable variability in study design and duration, study population, type of soy isoflavone employed in the intervention, and study outcomes, the evidence points to a lack of a protective role of soy isoflavones in the prevention of postmenopausal bone loss.
    Journal of Clinical Densitometry 09/2013; · 1.71 Impact Factor
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    ABSTRACT: There is an ongoing debate over the role of serum 25(OH) vitamin D [25(OH)D] levels in maintaining or improving physical performance and muscle strength. Much of the controversy is due to the variability between studies in participants' characteristics, baseline serum 25(OH)D levels, and baseline physical functioning. The aim of this ancillary study conducted within a randomized controlled clinical trial was to investigate whether supplementation with 400 or 2000 IU vitamin D3 daily for 6 months would improve measures of physical performance and muscle strength in a community-dwelling elderly population aged 65 to 95. Those with the slowest gait speed improved their ability to do chair-stand tests after vitamin D supplementation. This finding remained significant after controlling for potential confounding variables. There was also an inverse correlation between serum 25(OH)D levels and fat mass index (FMI) among women, suggesting that higher supplementation with vitamin D is needed as weight increases. The results of this study suggest that supplementation with vitamin D may be most beneficial in older populations who have low baseline physical functioning. © 2013 American Society for Bone and Mineral Research.
    Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 04/2013; · 6.04 Impact Factor
  • Violet S Lagari, Silvina Levis
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    ABSTRACT: Women have always looked for non-hormonal options to alleviate menopausal vasomotor symptoms and prevent menopausal bone loss. The use of complementary and alternative medicine for these purposes has particularly increased after the publication of the Women's Health Initiative's results suggesting that there might be more risks than benefits with hormone replacement. Phytoestrogens are plant-derived estrogens that, although less potent than estradiol, bind to the estrogen receptor and can function as estrogen agonists or antagonists. Soy isoflavones extracted from soy are the phytoestrogens most commonly used by menopausal women. Because typical Western diets are low in phytoestrogens and taking into account the general difficulty in changing dietary habits, most clinical trials in Western women have used isoflavone-fortified foods or isoflavone tablets. Although some women might experience a reduction in the frequency or severity of hot flashes, most studies point towards the lack of effectiveness of isoflavones derived from soy or red clover, even in large doses, in the prevention of hot flashes and menopausal bone loss.
    The Journal of steroid biochemistry and molecular biology 12/2012; · 2.66 Impact Factor
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    ABSTRACT: Objective The adequate dose of vitamin D supplementation for community-dwelling elderly people has not been thoroughly investigated. This study aims to determine the efficacy of a low-dose and a higher dose of vitamin D3 in maintaining 25 hydroxyvitamin D [25(OH)D] levels at or above 30 ng/ml.Methods This was a single site, double-blind, randomized exploratory clinical trial that enrolled adults aged 65 and older. Within strata of baseline 25(OH)D levels (< 30 vs. ≥ 30 ng/ml) subjects were randomized in a 1:2 ratio to receive either 400 or 2,000 IU vitamin D3 daily for 6 months. The main outcome measures were changes in serum 25(OH)D levels according to baseline 25(OH)D levels and dose of vitamin D3.Results At baseline, 39% (41/105) of participants had low 25(OH)D levels (< 30 ng/ml). After 6 months of vitamin D3 supplementation, 66% (21/32) of the participants on 400 IU and 24% (14/59) of the participants on 2,000 IU of vitamin D3 still had low 25(OH)D levels. The largest increases in serum 25(OH)D levels were observed in subjects with baseline levels < 30 ng/ml who received 2,000 IU of vitamin D daily.Conclusions Regardless of baseline 25(OH)D level, in persons aged 65 and older, 6-month vitamin D3 supplementation with 400 IU daily resulted in low 25(OH)D in most individuals, while 2,000 IU daily maintained 25(OH)D levels within an acceptable range in most people on this regimen.
    Endocrine Practice 07/2012; · 2.49 Impact Factor
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    ABSTRACT: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N -telopeptide of type I bone collagen, lipids, and thyroid function. After 2 years, no significant differences were found between the participants receiving soy tablets (n = 122) and those receiving placebo (n = 126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. clinicaltrials.gov Identifier: NCT00076050.
    Archives of internal medicine 08/2011; 171(15):1363-9. · 11.46 Impact Factor
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    ABSTRACT: Height and weight information is commonly used in clinical trials and in making therapeutic decisions in medical practice. In both settings, the data are often obtained by self-report. If erroneous, this practice could lead to inaccuracies in estimating renal function and medication doses or to inaccurate outcomes of research studies. Previous publications have reported lack of reliability of self-reported weight and height in the general population but have not addressed age-specific and ethnicity-specific subgroups in the U.S. population. The inaccuracy of self-reported weight and height could be particularly significant in times of considerable changes in body weight, such as at menopause, which is often associated with weight gain. We assessed the validity of self-reported height and weight in 428 women within the first 5 years of menopause, 70.6% of whom were Hispanic. Participants overestimated their height by 2.2±3.5 cm (mean±standard deviation [SD]) and underestimated their weight by 1.5±2.9 kg. As a group, based on self-reported measures, 33.3% were misclassified with respect to body mass index (BMI) category, and the difference between measured BMI and self-reported BMI was similar between Hispanic white and non-Hispanic white women, positively related to measured weight, and inversely related to measured height, years from menopause, and multiple parity. From the public health perspective, inaccurate self-report could lead to a considerable underestimation of the current obesity prevalence rates. In our study population, the prevalence of obesity (BMI ≥30 kg/m(2)) was 6.3% based on self-reported values and 18% based on measured height and weight, representing a 3-fold underestimation.
    Journal of Women s Health 03/2011; 20(4):599-604. · 1.42 Impact Factor
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    ABSTRACT: To determine the prevalence of hypovitaminosis D (serum 25-hydroxyvitamin D<32 ng/mL; HVD) in a population of elderly veterans and conduct a preliminary assessment of the efficacy of supplementation with cholecalciferol in correcting HVD. Randomized, double-blind, placebo-controlled clinical trial. Geriatric clinic at the Bruce W. Carter Veterans Affairs Medical Center, Miami, Florida. Veterans aged 70 and older. Oral cholecalciferol 2,000 IU daily or placebo for 6 months. Serum calcium, 25-hydroxyvitamin D, parathyroid hormone, and 24-hour urinary calcium. Of the 34 participants who completed the study, 62% had HVD at baseline. In the treatment group, mean serum 25-hydroxyvitamin D level rose from 28.4±7.9 ng/mL at baseline to 42.7±10.5 ng/mL at the end of the trial, but levels remained less than 32 ng/mL in three of 17 (18%) of the participants. In the placebo group, the baseline level of 27.7±8.3 ng/mL remained unchanged (28.8±8.7 ng/mL). Supplementation did not alter serum or urinary calcium levels and did not result in any adverse events. These initial observations suggest that, in older veterans, cholecalciferol 2,000 IU daily for 6 months is generally safe and corrects HVD in most but not all individuals.
    Journal of the American Geriatrics Society 02/2011; 59(2):286-90. · 3.98 Impact Factor
  • Violet S Lagari, Silvina Levis
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    ABSTRACT: The present review summarizes the results of epidemiological studies and clinical trials assessing the skeletal effects of soy foods and soy dietary supplements. Results from epidemiological studies suggest a beneficial skeletal effect in Asian women consuming typical Asian diets, but clinical trials are conflictive regarding the effects of phytoestrogens on bone mineral density and bone turnover markers in premenopausal and postmenopausal women. Much of the controversy lies in differences in study design, reporting of results, participants' age and menopausal status, and type and dose of phytoestrogen used. Although western women will likely continue to incorporate soy foods and soy supplements into their diets with the increased availability of these products, published data are inconsistent and do not support soy's protective effect against bone loss. This conflicting evidence should be taken into account when considering using isoflavones in the prevention of bone loss and consequently fractures.
    Current opinion in endocrinology, diabetes, and obesity 12/2010; 17(6):546-53.
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    Silvina Levis, Marcio L Griebeler
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    ABSTRACT: The findings of the Women's Health Initiative resulted in a sharp decline in the use of estrogen therapy. Increasingly, menopausal women have been interested in soy foods as an alternative to estrogen therapy for the treatment of menopausal symptoms. This article provides an overview of the limited number of studies that assess the effectiveness of soy foods to alleviate vasomotor and urogenital symptoms. The evidence of the efficacy of soy foods in improving menopausal symptoms is limited due to the small number of trials reporting conflicting results.
    Journal of Nutrition 11/2010; 140(12):2318S-2321S. · 4.20 Impact Factor
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    ABSTRACT: Following the results of the Women's Health Initiative, many women now decline estrogen replacement at the time of menopause and seek natural remedies that would treat menopausal symptoms and prevent bone loss and other long-term consequences of estrogen deficiency, but without adverse effects on the breast, uterus, and cardiovascular system. The results of most soy studies in this population have had limitations because of poor design, small sample size, or short duration. This report describes the study rationale, design, and procedures of the Soy Phytoestrogens As Replacement Estrogen (SPARE) study, which was designed to determine the efficacy of soy isoflavones in preventing spinal bone loss and menopausal symptoms in the initial years of menopause. Women ages 45 to 60 without osteoporosis and within 5 years from menopause were randomized to receive soy isoflavones 200mg daily or placebo for 2 years. Participants have yearly measurements of spine and hip bone density, urinary phytoestrogens, and serum lipids, thyroid stimulating hormone, and estradiol. Menopausal symptoms, mood changes, depression, and quality of life are assessed annually. The SPARE study recruited 283 women, 66.1% were Hispanic white. With a large cohort, long duration, and large isoflavone dose, this trial will provide important, relevant, and currently unavailable information on the benefits of purified soy isoflavones in the prevention of bone loss and menopausal symptoms in the first 5 years of menopause. Given the high proportion of Hispanics participating in the study, the results of this trial will also be applicable to this minority group.
    Contemporary clinical trials 03/2010; 31(4):293-302. · 1.51 Impact Factor
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    ABSTRACT: Chronic Fatigue Syndrome (CFS) studies from our laboratory and others described decreased natural killer cell cytotoxicity (NKCC) and elevated proportion of lymphocytes expressing the activation marker, dipeptidyl peptidase IV (DPPIV) also known as CD26. However, neither these assays nor other laboratory tests are widely accepted for the diagnosis or prognosis of CFS. This study sought to determine if NKCC or DPPIV/CD26 have diagnostic accuracy for CFS. Subjects included female and male CFS cases and healthy controls. NK cell function was measured with a bioassay, using K562 cells and (51)Cr release. Lymphocyte associated DPPIV/CD26 was assayed by qualitative and quantitative flow cytometry. Serum DPPIV/CD26 was measured by ELISA. Analysis by receiver operating characteristic (ROC) curve assessed biomarker potential. Cytotoxic function of NK cells for 176 CFS subjects was significantly lower than in the 230 controls. According to ROC analysis, NKCC was a good predictor of CFS status. There was no significant difference in NK cell counts between cases and controls. Percent CD2+ lymphocytes (T cells and NK cells) positive for DPPIV/C26 was elevated in CFS cases, but there was a decrease in the number of molecules (rMol) of DPPIV/C26 expressed on T cells and NK cells and a decrease in the soluble form of the enzyme in serum. Analyses by ROC curves indicated that all three measurements of DPPIV/CD26 demonstrated potential as biomarkers for CFS. None of the DPPIV/C26 assays were significantly correlated with NKCC. By ROC analysis, NKCC and three methods of measuring DPPIV/C26 examined in this study had potential as biomarkers for CFS. Of these, NKCC, %CD2+CD26+ lymphocytes and rMol CD26/CD2+ lymphocyte, required flow cytometry, fresh blood and access to a high complexity laboratory. Soluble DPPIV/C26 in serum is done with a standard ELISA assay, or with other soluble factors in a multiplex type of ELISA. Dipeptidyl peptidase IV on lymphocytes or in serum was not predictive of NKCC suggesting that these should be considered as non-redundant biomarkers. Abnormalities in DPPIV/CD26 and in NK cell function have particular relevance to the possible role of infection in the initiation and/or the persistence of CFS.
    PLoS ONE 01/2010; 5(5):e10817. · 3.73 Impact Factor
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    ABSTRACT: Chronic fatigue syndrome (CFS) is a complex, multi-symptom illness with a multisystem pathogenesis involving alterations in the nervous, endocrine and immune systems.Abnormalities in stress responses have been identified as potential triggers or mediators of CFS symptoms. This study focused on the stress mediator neuropeptide Y (NPY). We hypothesized that NPY would be a useful biomarker for CFS. The CFS patients (n = 93) were from the Chronic Fatigue and Related Disorders Clinic at the University of Miami and met the 1994 case definition of Fukuda and colleagues. Healthy sedentary controls (n = 100)) were from NIH or VA funded studies. Another fatiguing, multi-symptom illness, Gulf War Illness (GWI), was also compared to CFS. We measured NPY in plasma using a radioimmunoassay (RIA). Psychometric measures, available for a subset of CFS patients included: Perceived Stress Scale, Profile of Mood States, ATQ Positive & Negative Self-Talk Scores, the COPE, the Beck Depression Inventory, Fatigue Symptom Inventory, Cognitive Capacity Screening Examination, Medical Outcomes Survey Short Form-36, and the Quality of Life Scale. Plasma NPY was elevated in CFS subjects, compared to controls (p = .000) and to GWI cases (p = .000). Receiver operating characteristics (ROC) curve analyses indicated that the predictive ability of plasma NPY to distinguish CFS patients from healthy controls and from GWI was significantly better than chance alone. In 42 patients with CFS, plasma NPY had significant correlations (<0.05) with perceived stress, depression, anger/hostility, confusion, negative thoughts, positive thoughts, general health, and cognitive status. In each case the correlation (+ or -) was in the anticipated direction. This study is the first in the CFS literature to report that plasma NPY is elevated compared to healthy controls and to a fatigued comparison group, GWI patients. The significant correlations of NPY with stress, negative mood, general health, depression and cognitive function strongly suggest that this peptide be considered as a biomarker to distinguish subsets of CFS.
    Behavioral and Brain Functions 01/2010; 6:76. · 2.79 Impact Factor
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    ABSTRACT: Chronic Fatigue Syndrome (CFS) studies from our laboratory and others have described cytokine abnormalities. Other studies reported no difference between CFS and controls. However, methodologies varied widely and few studies measured more than 4 or 5 cytokines. Multiplex technology permits the determination of cytokines for a large panel of cytokines simultaneously with high sensitivity and with only 30 ul of plasma per sample. No widely accepted laboratory test or marker is available for the diagnosis or prognosis of CFS. This study screened plasma factors to identify circulating biomarkers associated with CFS. Cytokines were measured in plasma from female CFS cases and female healthy controls. Multiplex technology provided profiles of 16 plasma factors including the pro -inflammatory cytokines: tumor necrosis factor alpha (TNFalpha), lymphotoxin alpha (LTalpha), interleukin (IL) - IL-Ialpha, IL-1beta, IL-6; TH1 cytokines: interferon gamma (IFNgamma), IL-12p70, IL-2, IL-15; TH2: IL-4, IL-5; TH17 cytokines, IL-17 and IL-23; anti-inflammatory cytokines IL-10, IL-13; the inflammatory mediator and neutrophil attracting chemokine IL-8 (CXCL8). Analysis by receiver operating characteristic (ROC) curve assessed the biomarker potential of each cytokine. The following cytokines were elevated in CFS compared to controls: LTalpha, IL-1alpha, IL-1beta, IL-4, IL-5, IL-6 and IL-12. The following cytokines were decreased in CFS: IL-8, IL-13 and IL-15. The following cytokines were not different: TNFalpha, IFNgamma, IL-2, IL-10, IL-23 and IL-17. Applying (ROC) curve analyses, areas under the curves (AUC) for IL-5 (0. 84), LTalpha (0.77), IL-4 (0.77), IL-12 (0.76) indicated good biomarker potential. The AUC of IL-6 (0.73), IL-15 (0.73), IL-8 (0.69), IL-13 (0.68) IL-1alpha (0.62), IL-1beta (0.62) showed fair potential as biomarkers. Cytokine abnormalities are common in CFS. In this study, 10 of 16 cytokines examined showed good to fair promise as biomarkers. However, the cytokine changes observed are likely to more indicative of immune activation and inflammation, rather than specific for CFS. As such, they are targets for herapeutic strategies. Newer techniques allow evaluation of large panels of cytokines in a cost effective fashion.
    Journal of Translational Medicine 11/2009; 7:96. · 3.46 Impact Factor
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    ABSTRACT: Vitamin D, a multipurpose steroid hormone vital to health, has been increasingly implicated in the pathology of cognition and mental illness. Hypovitaminosis D is prevalent among older adults, and several studies suggest an association between hypovitaminosis D and basic and executive cognitive functions, depression, bipolar disorder, and schizophrenia. Vitamin D activates receptors on neurons in regions implicated in the regulation of behavior, stimulates neurotrophin release, and protects the brain by buffering antioxidant and anti-inflammatory defenses against vascular injury and improving metabolic and cardiovascular function. Although additional studies are needed to examine the impact of supplementation on cognition and mood disorders, given the known health benefits of vitamin D, we recommend greater supplementation in older adults.
    Current Psychiatry Reports 03/2009; 11(1):12-9. · 3.23 Impact Factor
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    ABSTRACT: There is a growing consensus that vitamin D recommended daily intakes for the elderly are far too low, and that all individuals should take as much vitamin D as needed to raise levels to between 32 to 40 ng/ml (80 to 100 nmol/L) (5, 108, 109). Supplementation will likely be necessary in most elderly, since according to current lifestyles, diet and sunlight alone are inadequate sources of vitamin D (17). We believe that to raise and maintain 25(OH) vitamin D levels at a minimum of 32 ng/ml (80 nmol/L), most elderly will require at least 2,000 IU of cholecalciferol per day. But many questions remain. Are other biological markers preferable to 25(OH) vitamin D to assess repletion? Do the current estimates of optimal serum levels provide health benefits for all conditions, or do optimal vitamin D levels differ depending on the target tissue? How much vitamin D, cholecalciferol, or ergocalciferol, should be given to maintain these levels? What are the molecular mechanisms by which vitamin D influences health and disease? Cross-sectional studies have suggested that low vitamin D levels not only predict nursing home admission but also are associated with increased mortality (1, 2). Further knowledge of the mechanisms of vitamin D action and prospective clinical trials designed to determine if supplementation resulting in vitamin D levels higher than those shown to reduce the risk of falls and fractures is also effective in reducing the burden of various medical conditions could help validate a cost-effective intervention that will provide greater quality of life and longevity and have a major public health impact.
    The Journal of Nutrition Health and Aging 07/2008; 12(6):366-73. · 2.39 Impact Factor
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    ABSTRACT: Vitamin D insufficiency is widespread, regardless of geographical location. It is particularly prevalent in the elderly and has far-ranging health consequences including: osteoporosis, falls, increased risk of cancer, and altered glucose and lipid metabolism. Increasing evidence strongly supports the benefits of vitamin D supplementation and also reveals that present recommendations are inadequate, especially for older individuals. Although additional studies are still needed to further optimize diagnostic and therapeutic approaches, physicians should consider prescribing cholecalciferol--at least 2000 international units (IU) per day--to all elderly patients. Oral cholecalciferol supplementation at that level is inexpensive, safe, and effective, and has great potential to improve the quality of life of the elderly.
    Geriatrics 05/2008; 63(4):24-30. · 1.35 Impact Factor
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    ABSTRACT: Obesity is associated with lower levels of serum 25-hydroxyvitamin D (25(OH)D). Obese individuals might need higher doses of vitamin D supplementation than the general population. In this cross-sectional study, associations between 25(OH)D serum levels, body mass index (BMI), and outdoor exercise were assessed in a population of 291 ambulatory patients attending the Osteoporosis Center at the University of Miami, mean age 62+/-13.48 years. Obesity was defined as BMI> or =30 kg/m(2) and hypovitaminosis D as 25(OH)D< or =30 ng/ml. Overall, prevalence of obesity was 14.1% and of hypovitaminosis D was 42.4%. Among Hispanics, there was a significantly higher prevalence of hypovitaminosis D in obese (63.2%) compared to non-obese individuals (35.8%). Outdoor exercise had a significant effect on the prevalence of hypovitaminosis D in Hispanics, with a lower prevalence in those performing outdoor exercise (24.1%) compared to those who did not (47.9%). After adjusting for age, gender, and ethnicity, those reporting outdoor exercise were 47% less likely to have hypovitaminosis D, while those with obesity had more than twice the risk. Since outdoor exercise may protect overweight individuals from hypovitaminosis D, prevention programs involving higher doses of vitamin D and/or outdoor exercise may result in additional metabolic and functional benefits in this population.
    The Journal of Steroid Biochemistry and Molecular Biology 03/2007; 103(3-5):679-81. · 3.98 Impact Factor
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    ABSTRACT: The optimal duration of treatment of women with postmenopausal osteoporosis is uncertain. To compare the effects of discontinuing alendronate treatment after 5 years vs continuing for 10 years. Randomized, double-blind trial conducted at 10 US clinical centers that participated in the Fracture Intervention Trial (FIT). One thousand ninety-nine postmenopausal women who had been randomized to alendronate in FIT, with a mean of 5 years of prior alendronate treatment. Randomization to alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003). The primary outcome measure was total hip bone mineral density (BMD); secondary measures were BMD at other sites and biochemical markers of bone remodeling. An exploratory outcome measure was fracture incidence. Compared with continuing alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4%; 95% confidence interval [CI], -2.9% to -1.8%; P<.001) and spine (-3.7%; 95% CI, -4.5% to -3.0%; P<.001), but mean levels remained at or above pretreatment levels 10 years earlier. Similarly, those discontinuing alendronate had increased serum markers of bone turnover compared with continuing alendronate: 55.6% (P<.001) for C-telopeptide of type 1 collagen, 59.5% (P < .001) for serum n = propeptide of type 1 collagen, and 28.1% (P<.001) for bone-specific alkaline phosphatase, but after 5 years without therapy, bone marker levels remained somewhat below pretreatment levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures (RR, 1.00; 95% CI, 0.76-1.32) was not significantly different between those continuing (19%) and discontinuing (18.9%) alendronate. Among those who continued, there was a significantly lower risk of clinically recognized vertebral fractures (5.3% for placebo and 2.4% for alendronate; RR, 0.45; 95% CI, 0.24-0.85) but no significant reduction in morphometric vertebral fractures (11.3% for placebo and 9.8% for alendronate; RR, 0.86; 95% CI, 0.60-1.22). A small sample of 18 transilial bone biopsies did not show any qualitative abnormalities, with bone turnover (double labeling) seen in all specimens. Women who discontinued alendronate after 5 years showed a moderate decline in BMD and a gradual rise in biochemical markers but no higher fracture risk other than for clinical vertebral fractures compared with those who continued alendronate. These results suggest that for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk. However, women at very high risk of clinical vertebral fractures may benefit by continuing beyond 5 years. clinicaltrials.gov Identifier: NCT 00398931.
    JAMA The Journal of the American Medical Association 12/2006; 296(24):2927-38. · 29.98 Impact Factor
  • 01/2006;

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704 Citations
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Institutions

  • 1998–2013
    • University of Miami Miller School of Medicine
      • • Division of Hospital Medicine
      • • Miami Veterans Affairs Medical Center
      Miami, Florida, United States
  • 2009–2011
    • University of Miami
      • Miller School of Medicine
      كورال غيبلز، فلوريدا, Florida, United States
  • 2008
    • U.S. Department of Veterans Affairs
      • Geriatric Research, Education and Clinical Center (GRECC)
      Washington, D. C., DC, United States