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Comparison of the effects of denosumab with either active vitamin D or native vitamin D on bone mineral density and bone turnover markers in postmenopausal osteoporosis.
Suzuki, T, Nakamura, Y, Tanaka, M, Kamimura, M, Ikegami, S, Uchiyama, S, Kato, H
Modern rheumatology. 2018;(2):376-379
Abstract
Osteoporosis is a worldwide health concern. Although treatment with denosumab plus the active vitamin D alfacalcidol has been found to improve femoral neck (FN) and distal forearm bone mineral density (BMD), there have been no reports on the efficacy or adverse effects of denosumab plus eldecalcitol (ELD) in primary osteoporosis patients. Fifty-six treatment-naïve post-menopausal women with primary osteoporosis were recruited and divided into denosumab plus native vitamin D or denosumab plus ELD. Ultimately, 26 subjects in the native vitamin D group and 24 in the ELD group were analyzed. Lumbar and total hip BMD significantly increased in both groups. However, there was no significant difference in the percent increase of lumbar and total hip BMD between two groups. FN-BMD was significantly increased from 6 to 12 months in the ELD group compared with baseline. This study revealed that combination therapy with denosumab and ELD could improve FN-BMD more effectively than denosumab plus native vitamin D. Thus, the addition of ELD may enhance the effects of denosumab treatment for primary osteoporosis.
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Clinical Inquiries: Does vitamin D without calcium reduce fracture risk?
Daly, S, Allison, C, Nashelsky, J
The Journal of family practice. 2016;(12):933-934
Abstract
Supplemental vitamin D without calcium--in doses averaging as much as 800 IU per day--doesn't reduce the risk of hip, vertebral, or nonvertebral fractures in postmenopausal women and older men.
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Circulating semaphorin-4D and plexin-B1 levels in postmenopausal women with low bone mass: the 3-month effect of zoledronic acid, denosumab or teriparatide treatment.
Anastasilakis, AD, Polyzos, SA, Makras, P, Gkiomisi, A, Sakellariou, G, Savvidis, M, Papatheodorou, A, Kokkoris, P, Terpos, E
Expert opinion on therapeutic targets. 2015;(3):299-306
Abstract
OBJECTIVE The evaluation of circulating semaphorin-4D (sema4D) and plexin-B1 in postmenopausal women with low bone mass and the effect of antiresorptive or osteoanabolic treatment. METHODS Serum samples were obtained from postmenopausal women with low bone mass at baseline and 3 months after zoledronic acid infusion (n = 30), denosumab injection (n = 30) or teriparatide initiation (n = 28) and from controls matched for age, age at menopause and body mass index (n = 30) at the same time points. MAIN OUTCOME MEASURES Circulating sema4D and plexin-B1. RESULTS Circulating sema4D increased following denosumab (p = 0.026), whereas decreased following teriparatide (p = 0.013). Sema4D/plexin-B1 ratio increased following denosumab (p = 0.004). At baseline, sema4D and plexin-B1 levels were higher in patients pre-treated with bisphosphonates compared to naïve ones (p < 0.001 and p = 0.001, respectively). In bivariate correlations sema4D was inversely correlated with serum carboxyterminal telopeptide of type 1 collagen (rs -0.282, p = 0.002), intact parathyroid hormone (rs -0.388, p < 0.001) and 25(OH)D (rs -0.316, p < 0.001), whereas there was a trend towards correlation with lumbar spine bone mineral density (rs -0.191, p = 0.053). CONCLUSIONS Sema4D levels are independently associated with previous bisphosphonate treatment, intact parathyroid hormone and 25(OH)D levels. Denosumab and teriparatide seem to exert an opposite effect on circulating sema4D levels. Further studies are needed to evaluate whether sema4D mediates the coupling effect that occurs following both antiresorptive and osteoanabolic treatment.
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Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial.
Jiang, Y, Zhang, ZL, Zhang, ZL, Zhu, HM, Wu, YY, Cheng, Q, Wu, FL, Xing, XP, Liu, JL, Yu, W, et al
Clinical interventions in aging. 2014;:121-7
Abstract
OBJECTIVE To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women. METHOD This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 μg/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD), new fracture onsets, and serum osteocalcin (OC) and undercarboxylated OC (ucOC) levels were compared with the baseline value in patients of both groups. RESULTS A total of 213 patients (90.3%) completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P<0.001); and the percentage increase of BMD in Group A was 2.2% and 1.8%, respectively (P<0.001). No difference was observed between groups. There were no changes in femoral neck BMD in both groups. Two patients (1.9%, 2/108) in Group M and four patients (3.8%, 4/105) in Group A had new fracture onsets (P>0.05). In Group M, OC and ucOC decreased from baseline by 38.7% and 82.3%, respectively (P<0.001). In Group A, OC and ucOC decreased by 25.8% and 34.8%, respectively (P<0.001). Decreases in serum OC and ucOC were more obvious in Group M than in Group A (P<0.001). The safety profile of menatetrenone was similar to alfacalcidol. CONCLUSION Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women.
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Comparative effects of dried plum and dried apple on bone in postmenopausal women.
Hooshmand, S, Chai, SC, Saadat, RL, Payton, ME, Brummel-Smith, K, Arjmandi, BH
The British journal of nutrition. 2011;(6):923-30
Abstract
Aside from existing drug therapies, certain lifestyle and nutritional factors are known to reduce the risk of osteoporosis. Among the nutritional factors, dried plum or prunes (Prunus domestica L.) is the most effective fruit in both preventing and reversing bone loss. The objective of the present study was to examine the extent to which dried plum reverses bone loss in osteopenic postmenopausal women. We recruited 236 women, 1-10 years postmenopausal, not on hormone replacement therapy or any other prescribed medication known to influence bone metabolism. Qualified participants (n 160) were randomly assigned to one of the two treatment groups: dried plum (100 g/d) or dried apple (comparative control). Participants received 500 mg Ca plus 400 IU (10 μg) vitamin D daily. Bone mineral density (BMD) of lumbar spine, forearm, hip and whole body was assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline, 3, 6 and 12 months to assess bone biomarkers. Physical activity recall and 1-week FFQ were obtained at baseline, 3, 6 and 12 months to examine physical activity and dietary confounders as potential covariates. Dried plum significantly increased BMD of ulna and spine in comparison with dried apple. In comparison with corresponding baseline values, only dried plum significantly decreased serum levels of bone turnover markers including bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase-5b. The findings of the present study confirmed the ability of dried plum in improving BMD in postmenopausal women in part due to suppressing the rate of bone turnover.
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Comparisons of serum sclerostin levels among patients with postmenopausal osteoporosis, primary hyperparathyroidism and osteomalacia.
Kaji, H, Imanishi, Y, Sugimoto, T, Seino, S
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association. 2011;(7):440-4
Abstract
Wnt-β-catenin signaling is important for bone formation. Sclerostin inhibits bone formation mainly by suppressing this signal, and several studies suggest that the suppression of sclerostin expression contributes to the bone anabolic action of parathyroid hormone (PTH). We therefore examined serum sclerostin levels using enzyme-linked immunosolvent assay in 18 patients with postmenopausal osteoporosis, 9 postmenopausal women with primary hyperparathyroidism (pHPT) and 7 patients with osteomalacia. Serum levels of sclerostin were significantly lower in the group with pHPT, compared with those with postmenopausal osteoporosis. Moreover, serum sclerostin levels were significantly lower in the group with tumor-induced osteomalacia, but not in the group with osteomalacia without tumor, compared with those with postmenopausal osteoporosis. In patients with pHPT, serum sclerostin levels were significantly and negatively correlated to serum calcium and PTH levels. In patients with postmenopausal osteoporosis, serum levels of sclerostin levels were significantly and positively related to serum calcium and creatinine levels. In conclusion, we showed that serum sclerostin levels are decreased presumably through endogenous PTH elevation in postmenopausal women with pHPT, compared with the patients with postmenopausal osteoporosis.
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Comparison between dietary assessment methods for determining associations between nutrient intakes and bone mineral density in postmenopausal women.
Farrell, VA, Harris, M, Lohman, TG, Going, SB, Thomson, CA, Weber, JL, Houtkooper, LB
Journal of the American Dietetic Association. 2009;(5):899-904
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Abstract
It is important to identify the role of nutrition in the treatment and prevention of osteoporosis. The goal of this study was to compare the equivalency of nutrient intakes assessed by diet records and the Arizona Food Frequency Questionnaire and the associations of these nutrients with bone mineral density (BMD). This is a secondary analysis of cross-sectional data that was analyzed from six cohorts (fall 1995 to fall 1997) of postmenopausal women (n=244; 55.7+/-4.6 years) participating in a 12-month, block-randomized, clinical trial. One-year dietary intakes were assessed using 8 days of diet records and the Arizona Food Frequency Questionnaire. Participants' BMD was measured at the lumbar spine (L2-L4), femur trochanter, femur neck, Ward's triangle, and total body using dual-energy x-ray absorptiometry. Linear regression analyses (P< or =0.05) were adjusted for the effects of exercise, hormone therapy use, body weight at 1 year, years post menopause, and total energy intake. Significant correlations (r=0.30 to 0.70, P< or =0.05) between dietary assessment methods were found with all dietary intake variables. Iron and magnesium were consistently and significantly positively associated with BMD at all bone sites regardless of the dietary assessment method. Zinc, dietary calcium, phosphorous, potassium, total calcium, and fiber intakes were positively associated with BMD at three or more of the same bone sites regardless of the dietary assessment method. Protein, alcohol, caffeine, sodium, and vitamin E did not have any similar BMD associations. Diet records and the Arizona Food Frequency Questionnaire are acceptable dietary tools used to determine the associations of particular nutrients and BMD sites in healthy postmenopausal women.
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Antiresorptive effects of phytoestrogen supplements compared with estradiol or risedronate in postmenopausal women using (41)Ca methodology.
Weaver, CM, Martin, BR, Jackson, GS, McCabe, GP, Nolan, JR, McCabe, LD, Barnes, S, Reinwald, S, Boris, ME, Peacock, M
The Journal of clinical endocrinology and metabolism. 2009;(10):3798-805
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Abstract
INTRODUCTION Reduction of ovarian estrogen secretion at menopause increases net bone resorption and leads to bone loss. Isoflavones have been reported to protect bone from estrogen deficiency, but their modest effects on bone resorption have been difficult to measure with traditional analytical methods. METHODS In this randomized-order, crossover, blinded trial in 11 healthy postmenopausal women, we compared four commercial sources of isoflavones from soy cotyledon, soy germ, kudzu, and red clover and a positive control of oral 1 mg estradiol combined with 2.5 mg medroxyprogesterone or 5 mg/d oral risedronate (Actonel) for their antiresorptive effects on bone using novel (41)Ca methodology. RESULTS Risedronate and estrogen plus progesterone decreased net bone resorption measured by urinary (41)Ca by 22 and 24%, respectively (P < 0.0001). Despite serum isoflavone profiles indicating bioavailability of the phytoestrogens, only soy isoflavones from the cotyledon and germ significantly decreased net bone resorption by 9% (P = 0.0002) and 5% (P = 0.03), respectively. Calcium absorption and biochemical markers of bone turnover were not influenced by interventions. CONCLUSIONS Dietary supplements containing genistein-like isoflavones demonstrated a significant but modest ability to suppress net bone resorption in postmenopausal women at the doses supplied in this study over a 50-d intervention period.
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Phytotherapy versus hormonal therapy for postmenopausal bone loss: a meta-analysis.
Xu, M, Qi, C, Deng, B, Deng, PX, Mo, CW
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2009;(4):519-26
Abstract
This meta-analysis included 14 randomized controlled trials involving 780 patients to compare phytotherapy with hormonal therapy in the treatment of postmenopausal bone loss. Current evidence suggests that phytotherapy may possess a similar effect on bone mineral density (BMD) values but clinically is not associated with a high incidence of uterine bleeding and breast pain as is hormonal therapy. Clinical trials indicate that phytotherapy may be a potential treatment for postmenopausal osteoporosis. The objective of this meta-analysis was to compare the efficacy and safety of phytotherapy with that of hormonal therapy, to assess the quality of phytotherapy trials, and to identify herbs used commonly in the treatment of postmenopausal bone loss. A total of 43 electronic databases were searched. The quality of eligible trials was assessed using Jadad's scale. Outcome measures were BMD values and adverse events. Revman 5.0 software was used for data syntheses and meta-analyses. The database search revealed 14 randomized controlled trials involving 780 patients that met the inclusion criteria, and four trials were graded as high quality (score 3-5). There was no significant difference in lumbar, femoral or forearm BMD values between subjects treated with phytotherapy and those treated with hormonal therapy (P>0.05), but the incidence of uterine bleeding and breast pain was significantly lower in those treated with phytotherapy than in those treated with hormonal therapy (P = 0.002 and P = 0.01). The six most commonly used herbs in the included trials were identified. Phytotherapy may not show effects beyond hormonal therapy, but may be safer than hormonal therapy in the treatment of postmenopausal bone loss. Further trials with high-quality study designs should be conducted in this field.
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[Austrian guidance for the pharmacological treatment of osteoporosis in postmenopausal women--update 2009].
Dimai, HP, Pietschmann, P, Resch, H, Preisinger, E, Fahrleitner-Pammer, A, Dobnig, H, Klaushofer, K, ,
Wiener medizinische Wochenschrift. Supplement. 2009;(122):1-34
Abstract
Osteoporosis is a systemic skeletal disease characterized by diminished bone mass and deterioration of bone microarchitecture, leading to increased fragility and subsequent increased fracture risk. Therapeutic measures therefore aim at reducing individual fracture risk. In Austria, the following drugs, all of which have been proven to reduce fracture risk, are currently registered for the treatment of postmenopausal osteoporosis: alendronate, risedronate, etidronate, ibandronate, raloxifene, teriparatide (1-34 PTH), 1-84 PTH, strontium ranelate and salmon calcitonin. Fluorides are still available, but their role in daily practice has become negligible. Currently, there is no evidence that a combination of two or more of these drugs could improve anti-fracture potency. However, treatment with PTH should be followed by the treatment with an anticatabolic drug such as bisphosphonates. Calcium and vitamin D constitute an important adjunct to any osteoporosis treatment.