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Denosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor-blind, active-controlled clinical trial.
Singh, I, Jose, V, Patel, R, Arora, S
Indian journal of pharmacology. 2021;(1):6-12
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Abstract
OBJECTIVE The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of denosumab-biosimilar and denosumab-reference in postmenopausal osteoporotic women from India. MATERIALS AND METHODS In this randomized, assessor-blind, active-control, multicenter trial, 114 patients were randomly allocated to receive denosumab-biosimilar (n = 58) or denosumab-reference (n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the primary end point. RESULTS Of 114 randomized patients, 111 (denosumab-biosimilar, n = 56; denosumab-reference, n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses, 110 (denosumab-biosimilar, n = 56; denosumab-reference, n = 54) were part of efficacy analysis, and 20 (denosumab-biosimilar, n = 10; denosumab-reference, n = 10) were part of PK analysis. The bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab-biosimilar and denosumab-reference (7.22 vs. 7.62; difference:-0.40; 95% confidence interval: -5.92, 5.12) showed no statistically relevant difference. Likewise, alkaline phosphatase (bone-specific) and PK parameters also did not show statistically relevant differences. Adverse events were reported in 44.83% of patients on denosumab-biosimilar versus 33.93% of patients on denosumab-reference; most events were mild or moderate and not related to the study drugs. No patients showed anti-denosumab antibody positivity. CONCLUSIONS Denosumab-biosimilar and denosumab-reference showed biosimilarity in osteoporotic postmenopausal women. Availability of denosumab-biosimilar provides a treatment alternative for patients.
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Clinical Research of the Application of Bone Turnover Markers in Monitoring the Short-Term Therapeutic Efficacy of Vitamin D in Postmenopausal Osteoporotic women in Harbin, China.
Zhang, Y, Wang, Y
The journal of nutrition, health & aging. 2020;(5):485-493
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Abstract
BACKGROUND The incidence of osteoporosis (OP) is increasing year by year. researches have shown that there was an intense link between the vitamin D (VitD) status and the efficacy of zoledronate (ZOL) in patients with osteoporosis. Since VitD is related to the geogen, its promotion effect on zoledronate has regional specificity. AIM: Combining dual-energy X-ray and bone turnover markers (BTM) to explore the VitD level in postmenopausal osteoporosis patients in Harbin and monitor its effect on the anti-osteoporosis effect of ZOL. METHODS A total of 120 patients with postmenopausal osteoporosis (PMO) were enrolled .These patients were divided into two groups with 25(OH)D levels = 10ng/ml as a critical point, and each group was randomly divided into experimental groups and control groups). All of the patients were conducted 5 mg ZOL. Then the experimental group was given calcitriol and calcium carbonate, and the control group was only given calcium carbonate. BTM were measured at baseline, 24h, 3 months and 6 months. We also measured bone mineral density (BMD) of bilateral hips (TH BMD) and lumbar spine (LS BMD) at baseline and 6 months. RESULTS The VitD deficiency rates of the patients enrolled were 84.1%. There was an inverse relationship between the baseline level of VitD and the serum levels of P1NP / β-CTX, (r=-0.452,p=0.00; r=-0.225, p=0.01). Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05). The mean decreasing rates of P1NP and β-CTX in the both experimental groups were significantly higher than that of the corresponding control groups at the same time point (P<0.05), after 6 months of medication. Both TH BMD and LS BMD at 6 months increased significantly. The increase rate of LS BMD in the high VitD experimental group was significantly higher than the other three groups (P<0.05), the increase rates of TH BMD in the low VitD control group were significantly lower than the other three groups (P<0.05). CONCLUSIONS The levels of serum VitD in the patients enrolled in this study were generally low. VitD could increase the therapeutic effect of ZOL on osteoporosis.
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Effect of Whole-Body Vibration Exercise on Power Profile and Bone Mineral Density in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.
ElDeeb, AM, Abdel-Aziem, AA
Journal of manipulative and physiological therapeutics. 2020;(4):384-393
Abstract
OBJECTIVE The purpose of this study was to investigate the effect of whole-body vibration (WBV) on muscle work and bone mineral density (BMD) of the lumbar vertebrae and femur in postmenopausal women. METHODS Forty-three postmenopausal women with low BMD were randomly assigned to WBV and control groups. Both groups received calcium and vitamin D supplementations once daily, while the WBV group additionally received WBV exercise (twice/wk) for 24 successive weeks. Qualisys gait analysis system was used to measure hip power generation by hip extensors (H1S) and flexors (H3S), hip power absorption by hip flexors (H2S), knee power absorption by quadriceps during loading response (K1S) and preswing (K3S), knee power absorption by hamstring (K4S), knee power generation by quadriceps (K2S), ankle power absorption by dorsiflexors (A1S) and plantar flexors (A2S), and ankle power generation by plantar flexors (A3S). Also, dual-energy X-ray absorptiometry was used to measure BMD of the lumbar vertebrae and femur before and after the intervention. RESULTS There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group. However, there were no significant changes (P > .05) in the control group. The posttreatment values of the hip, knee, and ankle muscle work and BMD of the WBV group were significantly (P < .05) higher than the posttreatment values of the control group. CONCLUSION Whole-body vibration training improved the leg muscle work and lumbar and femoral BMD in postmenopausal women with low BMD.
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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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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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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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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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[Catgut implantation at stellate ganglion for postmenopausal osteoporosis].
Gu, Z, Liang, P, Xie, S
Zhongguo zhen jiu = Chinese acupuncture & moxibustion. 2018;(5):4993-502
Abstract
OBJECTIVE To compare the efficacy differences between catgut implantation at stellate ganglion combined with oral administration of alendronate sodium and oral administration of alendronate sodium alone on postmenopausal osteoporosis (PO). METHODS Sixty patients of PO were randomly divided into an observation group and a control group, 30 cases in each one. The patients in the control group were treated with oral administration of alendronate sodium. Based on the treatment of control group, the patients in the observation group were treated with catgut implantation at stellate ganglion. The treatment was given once a week in the two groups; the consecution treatment of four weeks constituted one session, and totally six sessions were given. The changes of total syndrome score, bone mineral density of lumbar vertebra (L1 to L4) and femeral neck (FN) and estradiol were observed before and after treatment; the clinical efficacy was compared between the two groups. RESULTS Compared before treatment, the total syndrome score, bone mineral density of lumbar vertebra (L1 to L4) and FN and estradiol were significantly improved after treatment (all P<0.05); which were more significant in the observation group (all P<0.05). Compared before treatment, the level of estradiol in the control group was not significantly changed after treatment (P>0.05), while that in the observation group was significantly changed after treatment (P<0.05). After treatment, the level of estradiol in the observation group was higher than that in the control group (P<0.05). The total effective rate was 93.3% (28/30) in the observation group, which was significantly higher than 83.3% (25/30) in the control group (P<0.05). CONCLUSION Catgut implantation at stellate ganglion combined with oral administration of alendronate sodium are superior to oral administration of alendronate sodium alone for postmenopausal osteoporosis, which improve the clinical symptoms, regulate the hormone level and increase bone mineral density.
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Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide.
Reginster, JY, Hattersley, G, Williams, GC, Hu, MY, Fitzpatrick, LA, Lewiecki, EM
Calcified tissue international. 2018;(5):540-545
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Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data. To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE. NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE. The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials. NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture. NNT for these fracture types for teriparatide in ACTIVE were 30, 92, 59, and 75, respectively. Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31. These data are useful for further evaluating ABL for the treatment of osteoporosis in postmenopausal women.