Characteristics of Women Enrolled in a Patient Portal Intervention for Menopause.

Background: We developed a 6-month educational intervention addressing menopause and management of menopausal symptoms called "My HealtheVet to Enable And Negotiate for Shared decision-making" or MEANS. MEANS is offered through secure messaging via the My HealtheVet patient portal system. Materials and Methods: Women veterans aged 45-60 years registered at the Miami, West Palm Beach, and Orlando Veterans Affairs Healthcare Systems (VAHS). Intervention group: women in the Miami VAHS enrolled in My HealtheVet who were sent an invitation, agreed to participate, and completed the baseline survey. Comparison group: women from the Miami, West Palm Beach, and Orlando VAHS who responded to the baseline survey. Results: The intervention group enrolled 269 women at Miami VAHS: average age 53.2 years; 42.4% white, 43.1% black, and 24.2% Hispanic; 95.9% already used My Healthe Vet. The Comparison group had 590 women: average age 53.8 years; 70.8% white, 20.7% black, and 10.2% Hispanic; 57.6% already used My Healthe Vet. Conclusions: The differences between the intervention and comparison groups likely represent the regional demographic variations and the disparate recruitment techniques adopted for the two groups. Using within- and between-group comparisons at the end of the 6-month intervention, this novel project will evaluate the feasibility of a patient portal intervention on knowledge and shared decision-making regarding menopause among racially and ethnically diverse women. The study highlights the scalable and enormous potential for patient portals in nonurgent chronic disease management and shared decision-making, important in the existing health care climate, wherein "meaningful use" of electronic health records is mandated. Because of the COVID-19 pandemic, medical care has abruptly changed to telehealth and this approach to patient education is more relevant now than ever before. This quality improvement project's registration number is ClinicalTrials.gov ID: NCT03109145.

A Patient Portal Intervention for Menopause Knowledge and Shared Decision-Making.

Background: Menopause is a time often fraught with changes and symptoms, which may require difficult choices and decision-making. During this period, women would benefit from a better understanding and in-depth discussions with providers regarding menopause, associated conditions, and appropriate therapy. Patient portals offer a potential means to improve knowledge and shared decision-making (SDM) about menopause. Materials and Methods: This protocol article explores the feasibility of using the secure messaging (SM) function of the Veterans Affairs (VA) Patient Portal, "My HealtheVet" to implement an educational intervention and measure its impact on knowledge and SDM in the management of menopause. Results: This is a quality improvement pilot study in which women veterans of menopausal age in the Miami VA are offered an educational intervention via a patient portal, while women veterans in two neighboring VA facilities are not. Intervention participants receive weekly SMs with information on menopause symptoms, and treatment. After 6-months, all participants are surveyed on menopause knowledge, SDM, and satisfaction with the program. Conclusion: This study is among the first to assess the impact of an innovative patient portal intervention to improve knowledge and SDM between patients and providers regarding menopause. If successful, our program will add to the "meaningful use" of patient portals and offer a scalable and timely resource for SDM about menopause.

Under-Recognition of Fractures as Osteoporosis Indicators.

After the first fracture, the risk of subsequent fractures increases significantly. Medical treatment can reduce the risk of a second fracture by about 50%, but many older adults do not receive osteoporosis medication following their first fracture. This observational study aimed to understand primary care management patterns of older adults after osteoporotic fractures at the Miami Veterans Affairs (VA) Healthcare System. A retrospective review of 219 fracture cases selected by International Classification of Disease (ICD-9) codes between October 2015 and September 2016 identified 114 individuals age ≥50 years who had a non-traumatic fracture code entered in their medical record for the first time. Among them, 72 (63%) did not undergo a bone mineral density (BMD) test or receive treatment in the 12 months following their fracture. Of the 40 individuals who had a BMD test post-fracture, 17 (100%) received or were considered for anti-osteoporosis treatment if their T-score indicated osteoporosis (T-score ≤-2.5), but only 8/23 (35%) if the T-score was >-2.5. Physicians are more likely to prescribe osteoporosis therapy based on a BMD T-score diagnosis of osteoporosis, rather than a clinical diagnosis of osteoporosis based on a low-trauma fracture. A change in practice patterns is necessary to decrease the incidence of fractures.

Thyroid function in the etiology of fatigue in breast cancer.

BACKGROUND: Cancer related fatigue (CRF), reported in about 90% of breast cancer patients receiving chemotherapy, and has a profound impact on physical function, psychological distress and quality of life. Although several etiological factors such as anemia, depression, chronic inflammation, neurological pathology and alterations in metabolism have been proposed, the mechanisms of CRF are largely unknown. METHODS: We conducted a pilot, prospective, case-control study to estimate the magnitude of change in thyroid function in breast cancer patients from baseline to 24 months, compared to cancer-free, age-matched controls. Secondary objectives were to correlate changes in thyroid function and obesity over time with fatigue symptoms scores in this patient population. RESULTS: The proportion of women with breast cancer who developed subclinical or overt hypothyroidism (TSH >4.0 mIU/L) from baseline to year 1 was significantly greater compared to controls (9.6% vs. 5%; p=0.02). Subjects with breast cancer reported significantly worse fatigue symptoms than age-matched controls, as indicated by higher disruption indices (p<0.001 at baseline, p=0.02 at year 1, p=0.09 at year 2). Additionally, a significant interaction effect on disruption index score (p=0.019), general level of activity over time (p=0.006) and normal work activity (p= 0.002) was observed in the subgroup of women with BMI>30. CONCLUSION: Screening breast cancer patients for thyroid function status at baseline and serially post-treatment to evaluate the need for thyroid hormone replacement may provide for a novel strategy for treating chemotherapy-induced fatigue.

Mobile Technologies for Managing Heart Failure: A Systematic Review and Meta-analysis.

BACKGROUND: Randomized clinical trials (RCTs) conducted among heart failure (HF) patients have reported that mobile technologies can improve HF-related outcomes. Our aim was to conduct a meta-analysis to evaluate m-Health's impact on healthcare services utilization, mortality, and cost. METHODS: We searched MEDLINE, Cochrane, CINAHL, and EMBASE for studies published between 1966 and May-2017. We included studies that compared the use of m-Health in HF patients to usual care. m-Health is defined as the use of mobile computing and communication technologies to record and transmit data. The outcomes were HF-related and all-cause hospital days, cost, admissions, and mortality. RESULTS: Our search strategy resulted in 1,494 articles. We included 10 RCTs and 1 quasi-experimental study, which represented 3,109 patients in North America and Europe. Patient average age range was 53-80 years, New York Heart Association (NYHA) class III, and Left Ventricular Ejection Fraction <50%. Patients were mostly monitored daily and followed for an average of 6 months. A reduction was seen in HF-related hospital days. Nonsignificant reductions were seen in HF-related cost, admissions, and mortality and total mortality. We found no significant differences for all-cause hospital days and admissions, and an increase in total cost. CONCLUSIONS: m-Health reduced HF-related hospital days, showed reduction trends in total mortality and HF-related admissions, mortality and cost, and increased total costs related to more clinic visits and implementation of new technologies. More studies reporting consistent quality outcomes are warranted to give conclusive information about the effectiveness and cost-effectiveness of m-Health interventions for HF.

Women veterans and menopause: Knowledge and preferences.

The increasing number and older age of women Veterans receiving care at Veterans Health Administration (VHA) requires health-care providers to adjust to their changing patient population. We explored women Veterans' self-reported knowledge of menopause, current/preferred sources of menopausal health information, and perceptions/barriers regarding treatment of menopausal symptoms. Three focus groups were conducted at two South Florida VHA facilities in 2014, which included 30 women Veterans (aged 45-60 years) who visited VHA primary care clinics at least once in the past year. Participants reported using various sources to obtain general and menopausal health information, particularly family, friends, and the internet. Some women also had discussions with their health-care providers, but believed not all VHA providers were knowledgeable about menopause. Most preferred older female providers, thinking they were better informed about menopausal issues. Women favored complementary/alternative therapies and were against using hormone therapy (HT) for symptom relief, although they felt they were insufficiently informed about HT. Menopausal-age women are the fastest growing group at VHA. To provide better care and enhance their experiences, the VHA must educate all primary care providers about menopausal care and strive to address women Veterans' menopausal concerns and preferences.

Providing Dementia Consultations to Veterans Using Clinical Video Telehealth: Results from a Clinical Demonstration Project.

PURPOSE: Veterans with dementia and their caregivers in remote areas may not have access to specialists to provide diagnosis, treatment, and education. The purpose of this clinical demonstration project was to examine the feasibility, acceptability, and impact of a video consultations clinic for veterans with dementia or memory complaints and their caregivers. METHODS: The dementia clinical video telehealth (CVT) consultation clinic was established to identify, diagnose, and treat dementia in veterans at sites distant from the main medical center. A geriatrician at the main facility provided video consultation to patients and caregivers at seven satellite facilities. Diagnoses made and services provided were recorded after the initial consultation. Patient and caregiver satisfaction with the CVT clinic were assessed. FINDINGS: Ninety-four patients were evaluated in the CVT dementia clinic (average age = 74.7; average Mini-Mental State Exam = 24.4). Forty patients had a prior dementia diagnosis, 15 received a new dementia diagnosis, and 20 a new mild cognitive impairment diagnosis. Of the remaining patients evaluated for memory complaints, seven were found to have depression, three had hearing loss, and three had traumatic brain injury. After CVT consultation, common referrals included social work (n = 43), neuropsychology (n = 36), and brain imaging (n = 26). Patients and caregivers expressed high satisfaction with the video consultation and 90% of caregivers indicated they would rather use CVT than travel to see the specialist in person. CONCLUSIONS: Video consultation was well accepted by both dementia patients and caregivers. CVT may facilitate timely diagnosis and management and provide support for rural dementia patients and caregivers.

The Good and the Bad About the 2017 American College of Physicians Osteoporosis Guidelines.

PURPOSE: The American College of Physicians (ACP) published a set of guidelines on how to prevent fractures in men and women with low bone density or osteoporosis. As the population ages, the overall risk of fractures increases, thus burdening the health care system. These guidelines review current evidence for osteoporosis management, providing an update to the previous 2008 ACP's guidelines. METHODS: The ACP put forth 6 recommendations addressing the complexities in osteoporosis management based on evidence available through October 2016 with a focus on bisphosphonates, calcium, vitamin D, and estrogen. Evidence was graded according to recommended strength by using the ACP standard methods. FINDINGS: The ACP recommends anti-osteoporosis therapy with 1 of 3 bisphosphonates (alendronate, risedronate, or zoledronic acid) or denosumab in patients with osteoporosis, while excluding anabolic therapies, and recommends against raloxifene. Although bisphosphonates are the mainstay of treatment, anabolic therapy and raloxifene may be used in specific situations. Pharmacologic therapy is recommended for 5 years, oversimplifying length of therapy and failing to promote an individualized patient-centered care approach. Moreover, abrupt discontinuation of denosumab is associated with a decline in bone mineral density (BMD), which must be addressed. Routine monitoring of BMD by dual x-ray absorptiometry is not endorsed during treatment, which leads to underrecognition of management issues. Pharmacologic treatment with bisphosphonates for male osteoporosis is recommended, although therapies such as denosumab and teriparatide are excluded. Finally, the ACP recommends treatment for women aged ≥65 years at high risk for fracture with osteopenia after a discussion of patient preferences, fracture risk profile, and medications. IMPLICATIONS: Osteoporosis management is complex. The 2017 ACP guidelines address challenges faced by clinicians but oversimplify more complex issues. These are among a number of guidelines that are available for osteoporosis management, which may be used in combination with other sources to assist clinicians with diagnostic and management strategies.

Reproductive Health of Women Veterans: A Systematic Review of the Literature from 2008 to 2017.

The literature on the reproductive health and healthcare of women Veterans has increased dramatically, though there are important gaps. This article aims to synthesize recent literature on reproductive health and healthcare of women Veterans. We updated a literature search to identify manuscripts published between 2008 and July 1, 2017. We excluded studies that were not original research, only included active-duty women, or had few women Veterans in their sample. Manuscripts were reviewed using a standardized abstraction form. We identified 52 manuscripts. Nearly half (48%) of the new manuscripts addressed contraception and preconception care (n = 15) or pregnancy (n = 10). The pregnancy and family planning literature showed that (1) contraceptive use and unintended pregnancy among women Veterans using VA healthcare is similar to that of the general population; (2) demand for VA maternity care is increasing; and (3) women Veterans using VA maternity care are a high-risk population for adverse pregnancy outcomes. A recurrent finding across topics was that history of lifetime sexual assault and mental health conditions were highly prevalent among women Veterans and associated with a wide variety of adverse reproductive health outcomes across the life course. The literature on women Veterans' reproductive health is rapidly expanding, but remains largely observational. Knowledge gaps persist in the areas of sexually transmitted infections, infertility, and menopause.

Vitamin D and Physical Function in Sedentary Older Men.

OBJECTIVES: To determine the effectiveness of vitamin D supplementation in preventing decline in physical function in older men. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Single-center study conducted at a Veterans Affairs Healthcare System. PARTICIPANTS: Sedentary men aged 65 to 90 (mean 72.4 ± 6.8) with baseline 25-hydroxyvitamin D (25(OH)D levels of less than 30 ng/mL and Short Physical Performance Battery (SPPB) test scores of 9 or less (N = 130). INTERVENTION: Daily capsule containing cholecalciferol 4,000 IU daily or placebo for 9 months. MEASUREMENTS: Main outcomes were SPPB score and gait speed. RESULTS: After the intervention, serum 25(OH)D increased from 23.1 ± 5.0 ng/mL to 46.2 ± 12.7 ng/mL in the cholecalciferol group and from 22.5 ± 5.3 ng/mL to 24.0 ± 7.2 ng/mL in the placebo group. At study end, improvements in SPPB score and gait speed were not significantly greater in men receiving cholecalciferol than in those receiving placebo. No differences were found in adverse events or numbers of falls. CONCLUSION: Daily cholecalciferol 4,000 IU for 9 months resulted in significant increases in 25(OH)D concentrations, but achieving these higher levels did not result in improvements in SPPB score or gait speed. These data do not support prescribing vitamin D supplements to older sedentary men to prevent physical function decline.

Study design and baseline characteristics of participants in the Vitamin D in Vulnerable Adults at the VA (the VIVA Study).

Hypovitaminosis D has been associated with age-related physical decline and an increased risk for falls. The objective of this study is to test whether supplementation with 4000IU of vitamin D(3) (vitD(3)) for 9 months will improve, or slow down the decline of the ability to perform physical tests which have been associated with the preservation of independence in sedentary older men. We describe the study design and the baseline characteristics of the 314 men screened in the VIVA-VA Study (Vitamin D In Vulnerable Adults in the VA), a 2-year, single-site, double-blind, placebo-controlled, randomized clinical trial that enrolled sedentary male veterans ages 65 to 95. The main inclusion criteria are 25-OH vitamin D (25-OHD) levels between 10 and 30 ng/ml, and a Short Performance Physical Battery (SPPB) score ≤ 9. The primary outcome of the study is the SPPB. Subjects were recruited from the Miami Veterans Medical Center clinics. The study recruited 314 male veterans of multiethnic backgrounds. The baseline characteristics observed from the 314 men screened in the VIVA-VA Study are consistent with what is expected in a cohort of elderly sedentary men: low physical performance scores, and low 25OHD levels despite living in South Florida. The results of this study that uses a high dose of vitamin D in a cohort of sedentary older men could provide an evidence-based indication for vitamin D supplementation to improve physical performance in this population.

Phytoestrogens for menopausal bone loss and climacteric symptoms.

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. This article is part of a Special Issue entitled 'Phytoestrogens'.

Phytoestrogens in the prevention of postmenopausal bone loss.

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.

The role of vitamin D in improving physical performance in the elderly.

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 because of 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 years. 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.

The role of diet in osteoporosis prevention and management.

Diet, a modifiable osteoporosis risk factor, plays an important role in the acquisition and maintenance of bone mass. The influence of diet on bone begins in childhood; even maternal diet can influence bone mass in the offspring. A good general nutritional status and adequate dietary protein, calcium, vitamin D, fruits, and vegetables have a positive influence on bone health, while a high caloric diet and heavy alcohol consumption have been associated with lower bone mass and higher rates of fracture. The evidence for a role of other minerals and vitamins in skeletal health is not as strong, but recent evidence suggests that vitamins C and K might also have an effect on bone.

Differences in vitamin D3 dosing regimens in a geriatric community-dwelling population.

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 65 years of age and older. Within strata of baseline 25(OH)D levels (<30 versus ≥ 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, 41 of 105 participants (39%) had low 25(OH)D levels (<30 ng/mL). After 6 months of vitamin D3 supplementation, 21 of 32 participants (66%) receiving 400 IU and 14 of 59 participants (24%) receiving 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. CONCLUSION: Regardless of baseline 25(OH)D level, in persons 65 years of age 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.

Summary of AHRQ's comparative effectiveness review of treatment to prevent fractures in men and women with low bone density or osteoporosis: update of the 2007 report.

BACKGROUND: In 2007, the Agency for Healthcare Research and Quality(AHRQ) published a systematic review on the comparative effectiveness of treatments for osteoporosis. The review included studies on the benefits and risks of medications and therapies used to prevent fractures in postmenopausal women and men with low bone density (osteopenia) or osteoporosis. Factors that may affect adherence to treatment, and monitoring for the identification of those most likely to benefit from treatment were also included in this review. AHRQ published an updated review in March 2012 that summarized the benefits and risks of osteoporosis medications in treatment and prevention of osteoporosis, including bisphosphonates (aledronate, risedronate, ibandronate, zoledronic acid), parathyroid hormone, teriparatide, calcitonin, estrogens (for prevention in postmenopausal women), selective estrogen receptor modulators (raloxifene), and denosumab(approved by the FDA in 2010). In addition, dietary and supplemental calcium and vitamin D, as well as weight-bearing exercise, for the preservation of bone mass and the decrease of fracture risk in patients with osteoporosis, were evaluated. OBJECTIVES: To (a) familiarize health care professionals with the methods and findings from AHRQ's 2012 comparative effectiveness review on treatments to prevent fractures in men and women with low bone density or osteoporosis, (b) encourage consideration and application of the findings of this review in clinical and managed care settings, and (c) identify limitations and gaps in the existing research with respect to the benefits and risks of treatments for osteoporosis. SUMMARY: Osteoporosis is a prevalent systemic skeletal disease caused by bone deterioration and loss of mass resulting in fractures, chronic pain and physical disability. It is common in postmenopausal women but men are at risk as well for fractures associated with low bone density. The increasing prevalence and cost of treating osteoporosis make the study of safety and effectiveness for currently available osteoporosis therapies pertinent and timely. In 2012, the Agency for Healthcare Research and Quality (AHRQ) published an updated review on the effectiveness and safety of treatments for osteoporosis, including new therapies for the prevention of vertebral and nonvertebral fractures in postmenopausal women and men.The interventions assessed in the review included 1 biological agent, pharmacological agents, dietary and supplemental calcium and vitamin D, and weight-bearing exercise. The updated report included the new agents and indications approved after the 2007 report and new data on effectiveness and adverse events associated with the bisphosponates; calcitonin was determined by the reviewers to not be appropriate therapy for osteoporosis and was excluded. The updated review examined 5 key questions focused on comparative review of all FDA-approved medicines for osteoporosis in fracture risk reduction, effectiveness in racial/ethnic subpopulations as well as different risk stratification using FRAX (World Health Organization Fracture Risk Assessment Tool) or other cutoffs, compliance and adherence, adverse effects of medications, the prediction of treatment efficacy using bone mineral density (BMD) monitoring by dual energy x-ray absorptiometry (DXA), and comparative effectiveness of long-term therapy.The AHRQ reviewers found high strength of evidence to support a reduction in risk of vertebral, nonvertebral and hip fractures in postmenopausal women with osteoporosis treated with 1 of 4 agents (alendronate, risedronate, zoledronic acid, or denosumab). A risk reduction for vertebral fractures in postmenopausal women with osteoporosis treated with ibandronate, teriparatide, or raloxifene therapy was supported with high-strength evidence. Evidence was graded high strength for reduction of vertebral and hip fracture with estrogen therapy in postmenopausal women but not in women with established osteoporosis. Evidence was graded moderate for a reduction in nonvertebral fractures with teriparatide or calcium monotherapy. Moderate or low-moderate strength of evidence showed that calcium alone does not reduce the risk of vertebral or nonvertebral fracture, and that vitamin D has mixed results on decreasing overall fracture risk. High-strength evidence supports a reduction in the risk of hip fracture with calcium treatment. Vitamin D treatment significantly reduced vertebral fractures among patients with primary osteoporosis. The combination of calcium plus vitamin C did not reduce vertebral fracture risk, but did reduce nonvertebral fracture risk in certain populations. Calcium plus vitamin D did decrease the risk of fracture in elderly women but not in elderly men. Adherence and persistence to osteoporosis medications varied depending on patient age, prior history of fracture, dosing frequency, concomitant use of other medications, and adverse effects. Adherence to treatment improved with weekly dosing compared with daily regimens, but evidence was lacking to show monthly regimens improved adherence over weekly regimens. This article recaps the key findings from the AHRQ 2012 review for the purpose of informing health care providers about the efficacy and safety of therapies used to prevent osteoporotic vertebral, nonvertebral, hip, and wrist fractures. Scientific literature on the effects of risk factors, adherence, BMD monitoring, and long-term therapy on patient outcomes is reviewed in order to inform prescribing decisions. In addition, applications of the AHRQ findings to practice are discussed to provide clinicians with information needed to provide evidence-based care for their patients.

Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00076050.