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1.
Women's Values and Preferences Regarding Osteoporosis Treatments: A Systematic Review.
Barrionuevo, P, Gionfriddo, MR, Castaneda-Guarderas, A, Zeballos-Palacios, C, Bora, P, Mohammed, K, Benkhadra, K, Sarigianni, M, Murad, MH
The Journal of clinical endocrinology and metabolism. 2019;(5):1631-1636
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Abstract
BACKGROUND Several treatments are available to reduce the risk of fragility fractures associated with osteoporosis. The choice of treatment requires knowledge of patients' values and preferences. The aim of the present study was to summarize what is known about the values and preferences relevant to the management of osteoporosis in women. METHODS We conducted a comprehensive search of several databases for studies reported in any language that had included women who had already started or were about to start any pharmacological therapy for osteoporosis. Pairs of reviewers independently selected the studies and extracted the data. The results were synthesized narratively. RESULTS We included 26 studies reporting on 15,348 women (mean age, 66 years). The women considered the effectiveness and adverse events equally, followed by the convenience of taking the drug and its effect on daily routine (less frequent dosing was preferred, the oral route was preferred, and the injectable route was preferred over oral if given less frequently). The treatment cost and duration were less important factors for decision making. Fear of breast cancer and fear of resuming uterine bleeding were common reasons for not choosing estrogen therapy. Calcium and vitamin D were viewed as safe and natural. Across the studies, the preferences were not affected by age, previous drug exposure, or employment status. CONCLUSIONS Women starting osteoporosis medications value effectiveness and side effects equally and prefer medications given less frequently. Injectable drugs appear acceptable if given less frequently. More research on patient values and preferences is needed to guide decision making in osteoporosis.
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Effects of French maritime pine bark extract (Oligopin®) supplementation on bone remodeling markers in postmenopausal osteopenic women: A randomized clinical trial.
Panahande, SB, Maghbooli, Z, Hossein-Nezhad, A, Qorbani, M, Moeini-Nodeh, S, Haghi-Aminjan, H, Hosseini, S
Phytotherapy research : PTR. 2019;(4):1233-1240
Abstract
French maritime pine bark extract (FMPBE; Oligopin®), a dietary supplement, is rich in procyanidin. The objective of this study was to determine the effects of FMPBE on bone remodeling in postmenopausal osteopenic women. This randomized, double-blinded, placebo-controlled clinical trial was conducted on 40 postmenopausal osteopenic women. Individuals were randomly assigned to either FMPBE (250 mg/day, n = 21) or placebo (250-mg starch/day, n = 19) for 12 weeks. Biochemical indices, including bone remodeling marker, were assessed before and after the intervention. After the 12-week intervention, that is, FMPBE supplementation, a significant increase in bone alkaline phosphatase (BAP), procollagen type 1 amino-terminal propeptide (P1NP) levels and a significant decrease in C-terminal telopeptide of type I collagen (CTx1) were observed. Compared with the control group, FMPBE supplementation resulted in a significant increase in P1NP (0.015), BAP levels (0.001), and BAP/CTx1 ratio (p = 0.001) and a significant decrease in CTx1 levels (0.006). FMPBE supplementation for 12 weeks in postmenopausal osteopenic women produced favorable effects on bone markers. Meanwhile, further research is needed to determine whether FMPBE supplements can be used as a preventive strategy for bone loss in postmenopausal osteopenic women.
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Efficacy of Pharmacological Therapies for the Prevention of Fractures in Postmenopausal Women: A Network Meta-Analysis.
Barrionuevo, P, Kapoor, E, Asi, N, Alahdab, F, Mohammed, K, Benkhadra, K, Almasri, J, Farah, W, Sarigianni, M, Muthusamy, K, et al
The Journal of clinical endocrinology and metabolism. 2019;(5):1623-1630
Abstract
BACKGROUND Osteoporosis and osteopenia are associated with increased fracture incidence in postmenopausal women. We aimed to determine the comparative effectiveness of various available pharmacological therapies. METHODS We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ISI Web of Science, and Scopus for randomized controlled trials that enrolled postmenopausal women with primary osteoporosis and evaluated the risk of hip, vertebral, or nonvertebral fractures. A network meta-analysis was conducted using the multivariate random effects method. RESULTS We included 107 trials (193,987 postmenopausal women; mean age, 66 years; 55% white; median follow-up, 28 months). A significant reduction in hip fractures was observed with romosozumab, alendronate, zoledronate, risedronate, denosumab, estrogen with progesterone, and calcium in combination with vitamin D. A significant reduction in nonvertebral fractures was observed with abaloparatide, romosozumab, denosumab, teriparatide, alendronate, risedronate, zoledronate, lasofoxifene, tibolone, estrogen with progesterone, and vitamin D. A significant reduction in vertebral fractures was observed with abaloparatide, teriparatide, parathyroid hormone 1-84, romosozumab, strontium ranelate, denosumab, zoledronate, risedronate, alendronate, ibandronate, raloxifene, bazedoxifene, lasofoxifene, estrogen with progesterone, tibolone, and calcitonin. Teriparatide, abaloparatide, denosumab, and romosozumab were associated with the highest relative risk reductions, whereas ibandronate and selective estrogen receptor modulators had lower efficacy. The evidence for the treatment of fractures with vitamin D and calcium remains limited despite numerous large trials. CONCLUSIONS This network meta-analysis provides comparative effective estimates for the various available treatments to reduce the risk of fragility fractures in postmenopausal women.
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Cognition and Vitamin D in Older African-American Women- Physical performance and Osteoporosis prevention with vitamin D in older African Americans Trial and Dementia.
Owusu, JE, Islam, S, Katumuluwa, SS, Stolberg, AR, Usera, GL, Anwarullah, AA, Shieh, A, Dhaliwal, R, Ragolia, L, Mikhail, MB, et al
Journal of the American Geriatrics Society. 2019;(1):81-86
Abstract
OBJECTIVES To examine the effect of 25-hydroxyvitamin D (25(OH)D) levels recommended by Endocrine Society guidelines (>30 ng/mL) on cognition in healthy older African-American women over 3 years. DESIGN Randomized, double-blind, placebo-controlled clinical trial. SETTING Bone Mineral Research Center at New York University Winthrop Hospital. PARTICIPANTS Healthy postmenopausal African American women aged 65 and older (N=260; mean age 68.2 ± 4.9; 46% college education or higher). INTERVENTION Half of the women were randomized to receive vitamin D (adjusted to achieve a serum level > 30 ng/mL) with calcium (diet and supplement total of 1,200 mg), and half were randomized to receive placebo with calcium (1,200 mg). MEASUREMENTS Cognitive assessments every 6 months using the Mini-Mental State Examination (MMSE) to detect cognitive decline. Mean MMSE scores were calculated over time for both groups. Those with MMSE scores less than 21 at baseline were excluded. RESULTS The average dose of vitamin D3 was 3,490 ± 1,465 IU per day, and average serum 25(OH)D at 3 years was 46.8 ± 1.2 ng/mL in the active group and 20.7 ± 1.1 ng/mL in the placebo group. Serum 25(OH)D concentration was maintained at greater than 30 ng/mL in 90% of the active group. Over the 3-year period, MMSE scores increased in both groups (p < .001), although change over time was not significantly different between the groups. No adverse events associated with vitamin D were observed. CONCLUSION There was no difference in cognition over time between older African-American women with serum concentrations of 25(OH)D of 30 ng/mL and greater than those taking placebo. There is no evidence to support vitamin D intake greater than the recommended daily allowance in this population for preventing cognitive decline. J Am Geriatr Soc 67:81-86, 2019.
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Can increasing the prevalence of vegetable-based diets lower the risk of osteoporosis in postmenopausal subjects? A systematic review with meta-analysis of the literature.
Zeng, LF, Yang, WY, Liang, GH, Luo, MH, Cao, Y, Chen, HY, Pan, JK, Huang, HT, Han, YH, Zhao, D, et al
Complementary therapies in medicine. 2019;:302-311
Abstract
OBJECTIVES Several epidemiological investigations have assessed the association between vegetable-based diet intake (VDI) and risk of osteoporosis in postmenopausal subjects (OPS), but the outcomes have been inconsistent. We performed a review of the updated literature to evaluate this correlation. METHODS We searched for relevant studies published in September 2018 or earlier. Two researchers conducted eligibility assessment and data extraction. Discrepancies were resolved through consultation with a third expert. Pooled odds ratios (ORs) were calculated with 95% confidence intervals (CIs). RESULTS Ten studies, which included 14,247 subjects, were identified. On comparing the highest category of VDI consumption with the lowest category of VDI consumption, the pooled OR for OPS was 0.73 (95% CI = 0.57-0.95), i.e., participants with a higher intake of vegetables had a 27% (95% CI = 5-43%) lower risk of OPS. Significant benefits were found on subgroup analyses of case-control studies (OR, 0.61 [95% CI, 0.48-0.78]), but not on subgroup analyses of cross-sectional studies (OR, 0.82 [95% CI, 0.57-1.16]). The synthesized effect estimates were in the direction of decreased risk of OPS on subgroup analyses of the femoral region (OR, 0.57, 95% CI = 0.41-0.80) and the lumbar spine (OR = 0.55, 95% CI = 0.38-0.81), but not on subgroup analyses of the calcaneus (OR = 0.85, 95% CI = 0.33-2.16) and the lumbar and/or femoral region (OR = 1.04, 95%CI = 0.79-1.38). Positive results were observed on pooled analyses of the Dual energy X-ray absorptiometry (DEXA) measurement method (OR, 0.72 [95% CI, 0.54-0.95]), but not on pooled analyses of the Standardized Quantitative Ultrasound (QUS) measurement method (OR, 0.85 [95% CI, 0.33-2.16]). This might have resulted from a type II error due to wide confidence intervals and less number of included studies. CONCLUSION This meta-analysis seemingly confirms that higher consumption of VDI was associated with a lower risk of OPS. Taken together, these results highlight the need for future high-quality design-based trials on quantified vegetable intake and OPS.
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Bushen Yijing Fang Reduces Fall Risk in Late Postmenopausal Women with Osteopenia: A Randomized Double-blind and Placebo-controlled Trial.
Zheng, Y, Wang, X, Zhang, ZK, Guo, B, Dang, L, He, B, Zhang, C, Zhou, J, Shi, W, Zhao, Y, et al
Scientific reports. 2019;(1):2089
Abstract
Falls in late postmenopausal women with osteopenia usually cause fractures with severe consequences. This 36-month randomized, double-blind and placebo-controlled trial with a 10-year observational follow-up study aimed to investigate the long-term effect of herbal formula Bushen Yijing Fang (BSYJF) on fall risk in the late postmenopausal women with osteopenia. 140 late postmenopausal women (Femoral neck T-score, -2.5~-2 SD) were recruited and randomized to orally receive calcium carbonate 300 mg daily with either BSYJF or placebo for 36 months. The effect was further investigated for another 10-year follow-up. During the 36-month administration, there were 12 falls in BSYJF group and 28 falls in placebo group, respectively, indicating 64% lower risk of falls (RR 0.36 [95% CI, 0.18 to 0.71]; P = 0.004) in BSYJF group. During the 10-year follow-up, 36% lower fall risk (RR 0.64 [95% CI, 0.46 to 0.89]; P = 0.009) was observed in BSYJF group. No significant difference was found in safety profile between two groups. Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia. This clinical trial was registered at Chinese clinical trial registry (ChiCTR-IOR-16008942).
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Anti-fracture efficacy of zoledronate in subgroups of osteopenic postmenopausal women: secondary analysis of a randomized controlled trial.
Reid, IR, Horne, AM, Mihov, B, Stewart, A, Garratt, E, Wiessing, KR, Bolland, MJ, Bastin, S, Gamble, GD
Journal of internal medicine. 2019;(2):221-229
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Abstract
BACKGROUND We recently reported that the administration of zoledronate every 18 months to osteopenic older women reduces the incidence of fractures. OBJECTIVE Here, we present a more detailed analysis of that trial to determine whether baseline clinical characteristics impact on the anti-fracture efficacy of this intervention. METHODS This is a prospective, randomized, placebo-controlled, double-blind trial in osteopenic postmenopausal women aged ≥ 65 years, to determine the anti-fracture efficacy of zoledronate. 2000 women were recruited using electoral rolls and randomized to receive 4 infusions of either zoledronate 5 mg or normal saline, at 18-month intervals. Each participant was followed for 6 years. Calcium supplements were not supplied. RESULTS Fragility fractures (either vertebral or nonvertebral) occurred in 190 women in the placebo group (227 fractures) and in 122 women in the zoledronate group (131 fractures), odds ratio (OR) 0.59 (95%CI 0.46, 0.76; P < 0.0001). There were no significant interactions between baseline variables (age, anthropometry, BMI, dietary calcium intake, baseline fracture status, recent falls history, bone mineral density, calculated fracture risk) and the treatment effect. In particular, the reduction in fractures appeared to be independent of baseline fracture risk, and numbers needed to treat (NNT) to prevent one woman fracturing were not significantly different across baseline fracture risk tertiles. CONCLUSIONS The present analyses indicate that the decrease in fracture numbers is broadly consistent across this cohort. The lack of relationship between NNTs and baseline fracture risk calls into question the need for BMD measurement and precise fracture risk assessment before initiating treatment in older postmenopausal women.
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The Effect of Dried Beancurd on Bone Mineral Density in Postmenopausal Chinese Women: A 2-Year Randomized Controlled Trial.
Li, L, Sun, M, Sun, J, Kong, H, Zhong, W, Wang, H
Calcified tissue international. 2019;(6):573-581
Abstract
Soy foods contain several components such as isoflavones, calcium and protein that potentially modulate bone turnover and increase bone mineral density (BMD) in postmenopausal women. The study is to evaluate the effect of dried beancurd supplementation on skeletal health in postmenopausal Chinese women. Three hundred postmenopausal women aged 50-65 years were assigned into two groups, receiving 100 g dried beancurd or rice cake a day for 2 years. BMD at the lumbar spine and right proximal femur were measured with a dual-energy X-ray absorptiometry. The bone turnover biomarkers of serum alkaline phosphatase (ALP), bone Gla protein (BGP) and urinary N-telopeptide cross-links of collagen normalized for creatinine (NTX/CRT) were also determined. Serum isoflavone concentration was analyzed by high performance liquid chromatography. The 2-year dried beancurd supplementation generated a significant increase in lumbar spine BMD. An obvious decrease was found in urinary NTX/CRT, and a significant increase was detected in serum isoflavone concentration. The dried beancurd supplementation had no effect on changes of right proximal femur BMD and concentrations of serum ALP and BGP. Daily supplementation of dried beancurd could increase BMD of lumbar spine, but does not slow bone loss at right proximal femur in postmenopausal Chinese women.
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[The sequential therapy of romosozumab followed by denosumab for osteoporosis.].
Ono, K, Tanaka, S
Clinical calcium. 2019;(3):357-362
Abstract
Romosozumab is a bone-forming agent with a dual effect of increasing bone formation and decreasing bone resorption by inhibiting sclerostin. In the pivotal Fracture study in postmenopausal women with osteroposis(FRAME)and the extension trial, 12 months of romosozumab led to persistent fracture, especially new vertebral fracture, reduction benefit and ongoing BMD(bone mineral density)gains when follow 24 months of denosumab. The sequence therapy of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis.
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[Sequential treatment of osteoporosis with anti-sclerostin.].
Inoue, D
Clinical calcium. 2019;(3):363-369
Abstract
Romosozumab is a humanized anti-sclerostin monoclonal antibody that has just been approved for the treatment of osteoporosis in Japan. Romosozumab causes both transient stimulation of bone formation and continuous suppression of resorption, thereby increasing bone mineral density and decreasing fracture incidence. Because the effect of romosozumab is reversible, sequential therapy with anti-resorptives after romosozumab will be necessary. This overview summarizes the results of ARCH study demonstrating superior efficacy of romosozumab compared to alendronate and effect of sequential therapy with alendronate. Possible adverse effect of romosozumab on cardiovascular diseases will also be discussed.