scholarly journals A randomized clinical trial on improving osteopenia in postmenopausal women after two years of preventive treatment with alendronate; a dose of 35 mg per week is more effective or a dose of 70 mg?

2020 ◽  
Vol 5 (1) ◽  
pp. e16-e16
Author(s):  
Mansoor Karimifar ◽  
Negar Botlani ◽  
Amirhossein Salari
Keyword(s):  
Clinical Trial ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Assessment Tool ◽  
Preventive Treatment ◽  
Weekly Dose ◽  
Mineral Density ◽  
Main Complaint ◽  
Gastrointestinal Problems ◽  
Significant Difference

Introduction: Osteoporosis is the most common metabolic bone disease worldwide. In this disease, the bone mass decreases and as it progresses, the risk of fracture increases. Osteopenia occurs in the early stages of bone loss. Studies on the effective dose for treatment of osteopenia have been controversial. Objectives: In this randomized clinical trial, low doses versus high doses of alendronate were assessed during the osteopenic stage in postmenopausal women. Patients and Methods: The present study is a randomized clinical trial (RCT) that was performed on 152 postmenopausal women who were visited in Al-Zahra rheumatology clinic between 2016 and 2017. Patients were randomly divided into two groups. The first group with 35 and the second group with 70 mg of weekly alendronate were treated and followed for two years. Densitometry was performed on patients before and 2 years after the intervention, and the findings were compared. Results: The two groups were not significantly different in terms of age, gender, height, weight, body mass index (BMI) and menopause (P>0.05). The bone mineral density (BMD) findings of both groups, including Fracture Risk Assessment Tool (FRAX) hip and vertebra/wrist, T-score hip and vertebrae, as well as Z-score hip and vertebrae, improved significantly after two years (P<0.001), However, a comparison of the two therapeutic doses did not show a significant difference in terms of BMD improvements (P>0.05). Conclusion: The findings of this study reported favorable results for the preventive treatment of alendronate in osteopenic women. In addition, due to gastrointestinal problems that are the main complaint of alendronate use, according to the results, a weekly dose of 35 mg can be recommended

scholarly journals Performance of HR-pQCT, DXA, and FRAX in the discrimination of asymptomatic vertebral fracture in postmenopausal Chinese women

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Meiling Huang ◽  
Vivian Wing-yin Hung ◽  
Tsz Kiu Li ◽  
Sheung Wai Law ◽  
Yulong Wang ◽  
...  
Keyword(s):  
Vertebral Fracture ◽  
Fracture Risk ◽  
Postmenopausal Women ◽  
Bone Quality ◽  
Assessment Tool ◽  
Chinese Women ◽  
Quantitative Computed Tomography ◽  
Areal Bone Mineral Density ◽  
Mineral Density ◽  
Significant Difference

Abstract Summary Volumetric bone density (vBMD) and trabecular microarchitecture measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) can discriminate the patients with high risk of asymptomatic vertebral fracture (VF) in postmenopausal Chinese women. These findings suggested that HR-pQCT could provide additional information on bone quality of the patients with asymptomatic VF. Introduction Although there were several studies using HR-pQCT to investigate asymptomatic VF, it remains uncertain if HR-pQCT parameters can discriminate asymptomatic VF patients, especially in Chinese population. The purpose of this study was to investigate whether bone quality measured by HR-pQCT could discriminate asymptomatic VF independent of hip areal bone mineral density (aBMD) measured by dual-energy x-ray absorptiometry (DXA) and fracture risks evaluated using built-in Fracture Risk Assessment Tool (FRAXBMD). Methods This is a nested case–control study. One hundred seventy-five ambulatory Chinese postmenopausal women aged 60–79 years were retrieved from Normative Reference Standards (NRS) cohort in Hong Kong. DXA was used to identify VF from lateral spine images (VFA) using Genant’s semi-quantitative method. Major osteoporotic fracture risk was calculated using FRAX tool. HR-pQCT was used to assess vBMD, microarchitecture, and estimated strength at both distal radius and tibia. Comparison of HR-pQCT parameters between asymptomatic VF and control was performed using covariance analysis. Logistic regression analysis was performed for calculating the adjusted odds ratio (OR) with 95% confidence intervals (CI) of fracture status as per SD decrease in HR-pQCT parameters. Results Women with asymptomatic VF were older than those of the control in our NRS cohort. Nevertheless, after adjusted for covariance, asymptomatic VF showed significantly lower trabecular vBMD (Tb.vBMD) at radius but higher SMI at tibia as compared with those of the control. Tb.vBMD at radius yielded the highest value of area under the curve (AUC) as compared with total hip aBMD and FRAXBMD. However, no significant difference was found among each other. Conclusion Tb.vBMD at the radius and SMI at the tibia provided by HR-pQCT can discriminate asymptomatic VF independent of hip aBMD and FRAXBMD by DXA in postmenopausal women.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

The effect of Cornus mas extract consumption on bone biomarkers and inflammation in postmenopausal women: A randomized clinical trial

2021 ◽  
Author(s):  
Naheed Aryaeian ◽  
Fatemehsadat Amiri ◽  
Seyedeh Tayebeh Rahideh ◽  
Jamileh Abolghasemi ◽  
Shima Jazayeri ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postmenopausal Women ◽  
Randomized Clinical Trial ◽  
Bone Biomarkers ◽  
Cornus Mas

Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Freezing Of Gait ◽  
Motor Symptoms ◽  
Score Change ◽  
Significant Difference ◽  
Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

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