Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study

Abstract Summary Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population. Introduction Yigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL. Methods This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups. Results A total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: − 0.71 to 1.00, equivalence margin: − 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and β-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (β-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups. Conclusion Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.

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BMD status of Postmenopausal Women in relation with BMI: A study with 93 cases

Bangladesh Journal of Nuclear Medicine ◽

10.3329/bjnm.v17i2.28200 ◽

2016 ◽

Vol 17 (2) ◽

pp. 138-141

Author(s):

Samira Sharmin ◽

Mabubul Haque ◽

Syedur Rahman Miah ◽

Md Mahbub Ur Rahman ◽

Jasmine Ara Haque ◽

...

Keyword(s):

Lumbar Spine ◽

Femoral Neck ◽

Postmenopausal Women ◽

Lumbar Vertebrae ◽

The Body ◽

Mineral Density ◽

Cross Sectional ◽

T Score ◽

Minimal Trauma ◽

The Mean

Objectives: Low bone mass is a common disorder in elderly population which predisposes to fracture with minimal trauma. This study was performed to find out the association between the Body Mass Index (BMI) and Bone Mineral Density (BMD) in postmenopausal women.Materials and Methods: This cross sectional study was carried out at Institute of Nuclear Medicine and Allied Sciences Comilla and Mitford, Dhaka over a period of 12 months from January 2013 to December 2013. A total 93 postmenopausal women were enrolled for this study. All postmenopausal women underwent a BMD scan of femoral neck and lumbar vertebrae using a Dual Energy X-ray Absorptiometry (DEXA). Participants were categorized into three groups according to their age and BMI. BMD were expressed base on T-score according to WHO criteria. The relation among BMI, age and BMD were assessed.Results: The results of this study showed that the mean age of the study group was 57.13±7.49 years with range of 46 to 75 years. The most postmenopausal women were in age group 55-65years. The mean BMI of the study subjects were 24.18±5.08 kg/m2 with a range of 15.62 to 36.20 kg/m2. Among 93 subjects osteopenia was greater at lumbar spine (45.2%) with T-score mean±SD-1.83±0.33 and osteoporosis at femoral neck (51.6%) with T-score mean ±SD-3.36±-0.67. Pearsons correlation coefficient test showed inverse relationship between age and BMD both lumbar spine (r = -0.301, p = 0.003) and femoral neck (r = -0.303, p=0.003) whereas the positive relation between BMI and BMD both at lumbar spine (r=0.338, p=0.001) and femoral neck (r =0.343, p=0.001). These showed that with advancing age, BMD decreases and the risk of osteoporosis increases and with increasing BMI, BMD increases and risk of osteoporosis decreases.Conclusion: The findings of this study portrait that aging and low BMI are risk factors associated with bone loss. So preventive measure should be taken for high risk post menopausal women.Bangladesh J. Nuclear Med. 17(2): 138-141, July 2014

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SUN-377 Efficacy of Low Dose Denosumab in Maintaining Bone Mineral Density in Postmenopausal Women with Osteoporosis: A Real World, Prospective Observational Study

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa046.1431 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

Author(s):

Aliya Aziz Khan ◽

Hajar Abu Alrob ◽

Iman M’Hiri ◽

Hosay Said ◽

Sharjil Hussain ◽

...

Keyword(s):

Bone Mineral Density ◽

Monoclonal Antibody ◽

Single Dose ◽

Lumbar Spine ◽

Postmenopausal Women ◽

Low Dose ◽

Human Monoclonal Antibody ◽

Mineral Density ◽

Percent Change ◽

The Mean

Abstract Introduction: Denosumab, a fully human monoclonal antibody to RANK-ligand, has been shown to increase bone mineral density (BMD) and reduce the risk of hip, vertebral and non-vertebral fractures in postmenopausal women with osteoporosis (1-3). Varying doses of denosumab including 30mg/3months have demonstrated a decrease in bone remodelling in a dose-dependent manner (2,4-6). The primary objective of this study is to evaluate the efficacy of low dose denosumab (30mg/6 months) in postmenopausal women with osteoporosis who are reluctant to consider or continue the full dose of denosumab due to adverse events (AE) or concerns of potential AE. Methods: Following informed consent, postmenopausal women with a T-score of ≤ -2.5 at the lumbar spine (LS) or at the total hip (TH) received denosumab 30mg/6months. Patients with an additional skeletal disorder, prior fragility fracture, or on oral steroids (daily in the past 12 months) were excluded. The primary endpoint was the percent change in BMD at the lumbar spine (LS), total hip (HP), femoral neck (FN) and 1/3 radius (1/3R) at 12 months. Secondary outcomes were 1) percent change in BMD at the LS, TH, FN, and 1/3R at 24 months and 2) AE. Results: We enrolled 183 patients. The mean age was 69 years (SD= 7.07), 80% of patients had a moderate fracture risk (CAROC tool), 3% were current smokers and 9% consumed alcohol daily. 14.4% of patients were on SSRI/SNRI, 9.6% were on PPI, and no patient was on an aromatase inhibitor. At 12 months (n=125), the mean BMD significantly increased by +2.0% (95% CI 2.8%-1.3%) at the LS (p<0.001). There was no significant change in BMD at the FN, TH, AND 1/3R. At 24 months (n=65), the percent change in BMD was +3.4% (95% CI 4.8%-2.0%: p<0.001) at the LS, +1.5% (95% CI 2.9%-0.15%: p=0.031) at the FN, +1.9% (95% CI 3.5%-0.24%: p=0.025) at the 1/3R. There was no significant change in BMD at the TH. Conclusion: Low dose denosumab appears to be effective in maintaining BMD in postmenopausal women with a moderate fracture risk and may be of benefit in individuals who are experiencing side effects or concerns of side effects. This may also be of value following 10 years of therapy in order to maintain BMD. References 1.Bekker, PJ, Holloway DL, Rasmussen AS, Murphy R, Martin SW, Leese PT... Depaoli AM. A Single-Dose Placebo-Controlled Study of AMG 162, a Fully Human Monoclonal Antibody to RANKL, in Postmenopausal Women. JBMR, 2004;19(7), 1059-1066. 2.Kumagai Y, Hasunuma T, Padhi D. A randomized, double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of denosumab administered subcutaneously to postmenopausal Japanese women. Bone, 2011;49(5), 1101-1107. 3.Lewiecki EM, Miller PD, Mcclung MR, Cohen SB, Bolognese MA, Liu Y, . . . Fitzpatrick LA. Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. JBMR, 2007;22(12), 1832-1841.

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Efficacy and Safety of a Once-Yearly i.v. Infusion of Zoledronic Acid 5mg Versus a Once-Weekly 70-mg Oral Alendronate in the Treatment of Male Osteoporosis: A Randomized, Multicenter, Double-Blind, Active-Controlled Study

Yearbook of Endocrinology ◽

10.1016/j.yend.2011.04.008 ◽

2011 ◽

Vol 2011 ◽

pp. 195-197

Author(s):

B.L. Clarke

Keyword(s):

Zoledronic Acid ◽

Male Osteoporosis ◽

Controlled Study ◽

Efficacy And Safety ◽

Double Blind

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A case-controlled study on AngioJet rheolytic thrombectomy and catheter-directed thrombolysis in the treatment of acute lower extremity deep venous thrombosis

Vascular ◽

10.1177/1708538119877322 ◽

2019 ◽

Vol 28 (2) ◽

pp. 177-182 ◽

Cited By ~ 2

Author(s):

Jun Zhu ◽

Cai-Fang Ni ◽

Zhen-Yu Dai ◽

Li-Zheng Yao ◽

Wen-Hui Li

Keyword(s):

Deep Vein Thrombosis ◽

Lower Extremity ◽

Controlled Study ◽

Efficacy And Safety ◽

Vein Thrombosis ◽

Catheter Directed Thrombolysis ◽

Rheolytic Thrombectomy ◽

Thrombus Removal ◽

The Mean ◽

Deep Vein

Objective This study aims to compare the efficacy and safety of AngioJet rheolytic thrombectomy vs. catheter-directed thrombolysis in patients with acute lower extremity deep vein thrombosis. Methods Between the period of February 2015 and October 2016, 65 patients with documented acute lower extremity deep vein thrombosis were treated with catheter-directed intervention. These patients were divided into two groups: AngioJet group and catheter-directed thrombolysis group. Comparisons were made with regard to efficacy and safety between these two groups. Results In the AngioJet group, complete or partial thrombus removal was accomplished in 23 (72%) and 3 (9%) patients, respectively. In the catheter-directed thrombolysis group, complete or partial thrombus removal was accomplished in 27 (82%) patients and 1 (3%) patient, respectively. In the AngioJet group, the perimeter difference between the suffered limb and healthy one declined from 5.1 ± 2.3 cm to 1.4 ± 1.2 cm ( P < 0.05). In the catheter-directed thrombolysis group, the perimeter difference declined from 4.7 ± 1.6 cm to 1.5 ± 0.9 cm ( P < 0.05). The mean urokinase dose was 0.264 ± 0.135 million units in the AngioJet group and 1.869 ± 0.528 million units in the catheter-directed thrombolysis group ( P < 0.05). The duration of thrombolysis was 4.2 ± 1.7 h in the AngioJet group and 73.6 ± 18.3 h in the catheter-directed thrombolysis group ( P < 0.05). The occurrence of complications in these two groups was 19% and 18%, respectively (not significant). Conclusion AngioJet rheolytic thrombectomy is a new, safe and effective approach for treating acute lower extremity deep vein thrombosis. When compared to catheter-directed thrombolysis, this treatment provides similar success with lower urokinase dosage and shorter duration of thrombolysis.

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Once-Weekly Oral Alendronate 70 mg in Patients with Glucocorticoid-Induced Bone Loss: A 12-Month Randomized, Placebo-Controlled Clinical Trial

The Journal of Rheumatology ◽

10.3899/jrheum.081207 ◽

2009 ◽

Vol 36 (8) ◽

pp. 1705-1714 ◽

Cited By ~ 55

Author(s):

S. AUBREY STOCH ◽

KENNETH G. SAAG ◽

MARIA GREENWALD ◽

ANTHONY I. SEBBA ◽

STANLEY COHEN ◽

...

Keyword(s):

Lumbar Spine ◽

Bone Loss ◽

Glucocorticoid Therapy ◽

Percentage Change ◽

Significant Treatment ◽

Treatment Difference ◽

Total Hip ◽

The Mean ◽

Total Body ◽

Significant Treatment Difference

Objective.Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy.Methods.We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months.Results.At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p ≤ 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline.Conclusion.Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.

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