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Effect of antiresorptive therapy on aromatase inhibitor induced bone loss in postmenopausal women with early-stage breast cancer: A systematic review and meta-analysis of randomized controlled trials.
Bassatne, A, Bou Khalil, A, Chakhtoura, M, Arabi, A, Van Poznak, C, El-Hajj Fuleihan, G
Metabolism: clinical and experimental. 2022;:154962
Abstract
BACKGROUND Aromatase inhibitors (AIs) are routinely used to treat postmenopausal women with early-stage breast cancer. Although AIs improve breast cancer outcomes, they increase the risk of osteoporosis and fractures. This systematic review and meta-analysis assesses the effect of antiresorptive drugs on AI induced bone loss in postmenopausal women with non-metastatic breast cancer. METHODS We searched four databases until November 4th 2020. We included Randomized controlled trials (RCTs) of antiresorptive drugs in postmenopausal women with breast cancer treated with AI. Two authors screened studies, extracted data and assessed the risk of bias independently and in duplicate. RESULTS We identified 14 RCTs: 7 on zoledronic acid, 6 on oral bisphosphonates and 1 on denosumab. The mean difference in bone mineral density (BMD) was 5% at the lumbar spine and 4% at the total hip, at 12 months, favoring zoledronic acid compared to control. The certainty of the evidence was low for lumbar spine and moderate for total hip BMD. Similarly, the mean difference was 3% at the lumbar spine and 2% at the total hip, favoring oral bisphosphonates with moderate certainty. The mean difference was 6% at the lumbar spine, and 4% at the total hip BMD favoring denosumab compared to placebo. In addition, zoledronic acid resulted in a mean difference in bone turnover marker levels of -35-41%, and the relarive risk for morphometric vertebral fractures was 0.7 [0.3-1.4], compared to control. Denosumab reduced fracture incidence by 50% compared to placebo. CONCLUSION Evidence suggests a protective effect of antiresorptive drugs on BMD and bone turnover markers in postmenopausal women with non-metastatic breast cancer on AI. However, data on fracture risk reduction remains unclear.
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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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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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A meta-analysis of the therapeutic effect of intranasal salmon calcitonin on osteoporosis.
Li, N, Gong, YC, Chen, J
European journal of medical research. 2021;(1):140
Abstract
OBJECTIVE To evaluate the efficacy and safety of intranasal salmon calcitonin in the treatment of osteoporosis. METHODS Eight Chinese and English databases were searched by electronic search (from the establishment of the database to October 2019). The literature was screened according to the inclusion criteria and exclusion criteria, the quality was evaluated according to Cochrane software, and the Review Manager 5.2 software was used for statistical analysis. RESULTS A total of 374 documents were retrieved and 12 (12 original studies) were included after the screening, with a total sample capacity of 1068 cases. Meta-analysis showed that the intranasal salmon calcitonin had obvious advantages in reducing blood calcium, improving the ratio of serum creatinine and alkaline phosphatase. In addition, the intranasal salmon calcitonin had no obvious advantages in other indicators. It cannot be illustrated that the combination of intranasal salmon calcitonin and other conventional drugs is more effective than the simple use of conventional drugs. CONCLUSION The intranasal salmon calcitonin is superior to conventional drugs in reducing blood calcium, increasing creatinine ratio, and alkaline phosphatase, but its advantages in other indicators such as improving the bone mineral density (BMD) of lumbar vertebrae and hip have not been confirmed, and it is not clear that the combination of intranasal salmon calcitonin and other conventional drugs is better than the simple conventional drugs.
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Potential Role of Perilacunar Remodeling in the Progression of Osteoporosis and Implications on Age-Related Decline in Fracture Resistance of Bone.
Jähn-Rickert, K, Zimmermann, EA
Current osteoporosis reports. 2021;(4):391-402
Abstract
PURPOSE OF REVIEW We took an interdisciplinary view to examine the potential contribution of perilacunar/canalicular remodeling to declines in bone fracture resistance related to age or progression of osteoporosis. RECENT FINDINGS Perilacunar remodeling is most prominent as a result of lactation; recent advances further elucidate the molecular players involved and their effect on bone material properties. Of these, vitamin D and calcitonin could be active during aging or osteoporosis. Menopause-related hormonal changes or osteoporosis therapies affect bone material properties and mechanical behavior. However, investigations of lacunar size or osteocyte TRAP activity with age or osteoporosis do not provide clear evidence for or against perilacunar remodeling. While the occurrence and potential role of perilacunar remodeling in aging and osteoporosis progression are largely under-investigated, widespread changes in bone matrix composition in OVX models and following osteoporosis therapies imply osteocytic maintenance of bone matrix. Perilacunar remodeling-induced changes in bone porosity, bone matrix composition, and bone adaptation could have significant implications for bone fracture resistance.
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Efficacy and safety of Xianling Gubao capsule in treating postmenopausal osteoporosis: A protocol for systematic review and meta-analysis.
Lou, F, Xian, S, Shu, Z, Zheng, Z
Medicine. 2021;(1):e23965
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BACKGROUND postmenopausal osteoporosis is a systemic metabolic skeletal disease associated with menopause-related estrogen withdrawal. postmenopausal osteoporosis is characterized by low bone mass, bone microstructure destruction, leading to increased bone brittleness and be prone to fracture, resulting in disability and death. At present, the commonly used drugs are estrogen, calcium, bone formation promoter and bone resorption inhibitor, and the side effects are obvious. In Traditional Chinese medicine, kidney-tonifying differentiating medicine is guided by the whole concept, Xianling Gubao capsule as the representative, the treatment of postmenopausal osteoporosis has certain therapeutic advantages, but lacks evidence-based medicine evidence. The purpose of this study is to systematically study the efficacy and safety of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. METHODS use computer to search English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (China Knowledge Network, Wanfang, Weipu, Chinese Biomedical Database), in addition manually search Baidu academic, Google academic, from the establishment of database to October 2020, for randomized controlled clinical study of postmenopausal osteoporosis in the Xianling Gubao capsule treatment. Two researchers independently did the data extraction and literature quality evaluation, using RevMan5.3 software to do meta-analysis of the included literature. RESULTS this study assessed the efficacy and safety of xianling gubao capsule in the treatment of postmenopausal osteoporosis by total effective rate, bone density after treatment, blood calcium level after treatment, blood phosphorus level after treatment, pain score, quality of life and so on. CONCLUSION this study will provide reliable evidence-based evidence for the clinical application of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. OSF REGISTRATION NUMBER DOI 10.17605/OSF.IO/TP394.
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The association between vitamin D receptor FokI gene polymorphism and osteoporosis in postmenopausal women: a meta-analysis.
Wang, S, Ai, Z, Song, M, Yan, P, Li, J, Wang, S
Climacteric : the journal of the International Menopause Society. 2021;(1):74-79
Abstract
OBJECTIVE This study aimed to quantitatively summarize the evidence for vitamin D receptor (VDR) FokI gene polymorphism and osteoporosis risk in Caucasian and Asian postmenopausal women. MATERIALS AND METHODS The PubMed, EMBASE, Weipu, CNKI, and Wanfang databases were searched for eligible studies. Case-control studies containing available genotype frequencies for F/f were chosen, and the odds ratio (OR) with 95% confidence interval (CI) was used to assess the strength of this association. RESULTS In total, 3349 osteoporosis cases and 3202 controls were identified in our meta-analysis. In the stratified analysis, a significant association was observed between VDR FokI gene polymorphism and postmenopausal osteoporosis susceptibility in Asian subjects (additive model: OR = 1.529, 95% CI 1.053-2.219, p = 0.026; dominant model: OR 2.711, 95% CI 1.693-4.342 p < 0.001; co-dominant model: ff vs. FF, OR 2.796, 95% CI 1.439-5.433 p = 0.002), and we failed to find any significant relationship in Caucasian populations. CONCLUSION The present meta-analysis suggests that the VDR FokI genotype is associated with increased risk of osteoporosis in Asian women but not in Caucasian women. To draw comprehensive and true conclusions, further prospective studies with larger numbers of participants worldwide are needed to examine associations between VDR FokI polymorphism and osteoporosis.
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Calcium supplements: Good for the bone, bad for the heart? A systematic updated appraisal.
Morelli, MB, Santulli, G, Gambardella, J
Atherosclerosis. 2020;:68-73
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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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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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Cumulative network meta-analyses, practice guidelines, and actual prescriptions for postmenopausal osteoporosis: a meta-epidemiological study.
Kataoka, Y, Luo, Y, Chaimani, A, Onishi, A, Kimachi, M, Tsujimoto, Y, Murad, MH, Li, T, Cipriani, A, Furukawa, TA
Archives of osteoporosis. 2020;(1):21
Abstract
UNLABELLED We compared the cumulative network meta-analyses with the recommendations in postmenopausal osteoporosis practice guidelines and actual prescribing practices in the USA. There was no apparent discrepancy between guideline recommendations and drug prescribing rankings, with the exception of vitamin D and calcium, when we used cumulative NMAs as references. PURPOSE To compare the results of cumulative network meta-analyses (NMAs) with the recommendations in postmenopausal osteoporosis practice guidelines and actual prescribing practices in the USA. METHODS MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus were searched to retrieve randomized controlled trials (RCTs) in July 2017. The Agency for Healthcare Research and Quality's National Guideline Clearinghouse and associated society websites were searched to retrieve guidelines in June 2018. We used the Medical Expenditure Panel Survey (MEPS) to analyze prescription data from 1996 to 2015. Two independent investigators selected eligible RCTs. One investigator selected potential eligible guidelines, which were confirmed by another investigator. Two independent investigators extracted data from included RCTs. One investigator extracted recommendations from guidelines, which were confirmed by another investigator. (Registration: UMIN000031894) RESULTS We analyzed data from 1995, 2000, 2005, 2010, and 2015. We chose hip fracture as the primary outcome of cumulative NMAs. We included 51 trials, 17 guidelines, and 5099 postmenopausal osteoporosis patients from the MEPS. Bisphosphonate, including alendronate, and combination of vitamin D and calcium (vDCa) were consistently recommendable from an efficacy viewpoint in NMAs and recommended in guidelines. Alendronate was the most prescribed drug (more than 30% over the observation period); however, vDCa was seldom prescribed. The maximum proportion was 5.3% from 2011 to 2015. CONCLUSIONS In postmenopausal osteoporosis, there was no apparent discrepancy between guideline recommendations and drug prescribing rankings, with the exception of vDCa, when we used cumulative NMAs as references.