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The effect of zoledronic acid on the clinical resolution of Charcot neuroarthropathy: a pilot randomized controlled trial.

ABSTRACT: OBJECTIVE: To investigate the clinical efficacy of zoledronic acid in patients with diabetes and acute Charcot neuroarthropathy. RESEARCH DESIGN AND METHODS: Thirty-nine consecutive patients were randomly assigned to placebo or three intravenous infusions of 4 mg zoledronic acid. The primary outcome was clinical resolution of acute Charcot neuroarthropathy determined by total immobilization time (casting plus orthosis). RESULTS: At baseline, there was no significant difference between the randomly assigned groups with respect to Charcot disease activity or other baseline values. In the zoledronic acid group, the median time for total immobilization was 27 weeks (range 10-62), and in the placebo group it was 20 weeks (20-52) (P=0.02). CONCLUSIONS: Zoledronic acid had no beneficial effect on the clinical resolution of acute Charcot neuroarthropathy in terms of total immobilization time. It is possible that it may prolong the time to clinical resolution of Charcot neuroarthropathy.

SUBMITTER: Pakarinen TK

PROVIDER: S-EPMC3120211 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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The effect of zoledronic acid on the clinical resolution of Charcot neuroarthropathy: a pilot randomized controlled trial.

Pakarinen Toni-Karri TK Laine Heikki-Jussi HJ Mäenpää Heikki H Mattila Pentti P Lahtela Jorma J

Diabetes care 20110518 7

<h4>Objective</h4>To investigate the clinical efficacy of zoledronic acid in patients with diabetes and acute Charcot neuroarthropathy.<h4>Research design and methods</h4>Thirty-nine consecutive patients were randomly assigned to placebo or three intravenous infusions of 4 mg zoledronic acid. The primary outcome was clinical resolution of acute Charcot neuroarthropathy determined by total immobilization time (casting plus orthosis).<h4>Results</h4>At baseline, there was no significant difference ...[more]

PMID: 21593295

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Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:IntroductionAnimal studies have shown Zoledronic Acid (ZA) may diminish pleural fluid accumulation and tumour bulk in malignant pleural disease (MPD). We performed a pilot study to evaluate its effects in humans.MethodsWe undertook a single centre, double-blind, placebo-controlled trial in adults with MPD. Patients were randomised (1:1) to receive 2 doses of intravenous ZA or placebo, 3 weeks apart and were followed-up for 6 weeks. The co-primary outcomes were change in Visual Analogue Scale (VAS) score measured breathlessness during trial follow-up and change in the initial area under the curve (iAUC) on thoracic Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) from randomisation to week 5. Multiple secondary endpoints were also evaluated.ResultsBetween January 2010 and May 2013, 30 patients were enrolled, 24 randomised and 4 withdrew after randomisation (1 withdrew consent; 3 had a clinical decline). At baseline, the ZA group were more breathless, had more advanced disease on radiology and worse quality of life than the placebo group. There was no significant difference between the groups with regards change in breathlessness (Adjusted mean difference (AMD) 4.16 (95%CI -4.7 to 13.0)) or change in DCE-MRI iAUC (AMD -15.4 (95%CI -58.1 to 27.3). Two of nine (22%) in the ZA arm had a >10% improvement by modified RECIST (vs 0/11 who received placebo). There was no significant difference in quality of life measured by the QLQ-C30 score (global QOL: AMD -4.1 (-13.0 to 4.9)), side effects or serious adverse event rates.ConclusionsThis is the first human study to evaluate ZA in MPD. The study is limited by small numbers and imbalanced baseline characteristics. Although no convincing treatment effect was identified, potential benefits for specific subgroups of patients cannot be excluded. This study provides important information regarding the feasibility of future trials to evaluate the effects of ZA further.Trial registrationUK Clinical Research Network ID 8877 ISRCTN17030426 www.isrctn.com.

Project description:IntroductionSleeve gastrectomy (SG) is an increasingly used and effective treatment for obesity; however, the rapid weight loss associated with SG adversely affects bone metabolism predisposing patients to skeletal fragility. Bisphosphonate medications have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in SG-induced bone loss is limited. The goal of this study is to investigate how a one-time infusion of zoledronic acid compares to placebo, in its ability to combat SG-associated bone loss.Methods and analysisThis research protocol is a 9-month, pilot randomized controlled trial (RCT) involving 30 adult SG patients randomised to receive an infusion of either 5 mg of zoledronic acid or placebo, 6 weeks following surgery. To be included participants must be <350 lbs/158.8 kg, free of bone-impacting pathologies or medications, and must have adequate serum calcium and vitamin D levels at baseline. The primary outcome is change in areal bone mineral density (aBMD) at the total hip. Secondary outcomes include change in aBMD of the femoral neck, and lumbar spine, and change in volumetric BMD at the lumbar spine. The primary aim will be tested using a linear mixed model fit with total hip aBMD at 9 months as the outcome. Treatment, participant sex and menopausal status will be considered in analysis. Groups will be compared using contrast statements at 9 months, with change over 9 months being the primary comparison.Ethics and disseminationThis study was approved by the Institutional Review Board of the University of Nebraska Medical Center (IRB820-19). Written consent will be obtained from participants at enrolment by trained staff. Careful and thorough explanation are used in obtainment of consent and voluntariness is emphasised throughout the trial. The findings of this study will be presented locally, nationally, and published in peer-reviewed journals. Additional details will be reported on ClinicalTrials.gov.Trial registration numberNCT04279392.

Project description:BackgroundGlobally, nurses are facing increased pressure to provide high-quality complex patient care within environments with scarce resources in terms of staffing, infrastructure, or financial reward. The strain and demand on the psychological health and well-being of nurses during COVID-19 has been substantial, with many experiencing burnout; as such, interventions to enhance resilience within the workplace are required. A face-to-face resilience enhancement training program for nurses that was effective in improving resilience levels was translated into a 4-week online training program, Resilience Enhancement Online Training for Nurses (REsOluTioN), to enable greater accessibility for nurses.ObjectiveThis study aims to compare levels of resilience, psychological health, and well-being in nurses before and after the online resilience training compared to a wait list control group. It will also explore participants' engagement with the trial and their acceptability of the online training.MethodsThis is a two-arm, parallel, randomized controlled trial with a 6-week follow-up period. Up to 100 registered nonagency nurses working at a National Health Service hospital trust in South England will be recruited. Four cohorts will run, and participants will be randomized into a wait list control group or to REsOluTioN. Pre- and postonline surveys will collect study outcome measure data. In the REsOluTioN arm, data will be collected on the perceived usefulness of the online training via an online survey. Institutional and health research authority approvals have been obtained.ResultsREsOluTioN will aim to empower nurses to maintain and enhance their resilience while working under challenging clinical conditions. The online training will be interactive with input from mentors, health care leaders, and peers to promote engagement and enhanced communication, and will create a forum where nurses can express their views and concerns, without hierarchical infrastructures inhibiting them. This can increase self-knowledge and learning around workplace resilience coping strategies and provide a safe space to validate feelings through mentorship and peer support. Findings will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The trial is now finished and was conducted between August 2021 and May 2022.ConclusionsThe REsOluTioN trial will enable preliminary data to be gathered to indicate the online training's effectiveness in enhancing nurses' resilience in the workplace, with the potential for larger scale follow-up studies to identify its value to nurses working across a range of health care settings.Trial registrationClinicalTrials.gov NCT05074563; https://clinicaltrials.gov/ct2/show/NCT05074563.International registered report identifier (irrid)DERR1-10.2196/37015.

Project description:The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5?mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p?=?.0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p?=?.0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR)?=?0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR?=?0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR?=?0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR?=?0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that patients reported back pain, limited activity owing to back pain, and limited activity and bed rest owing to a fracture.

Dataset Information

The effect of zoledronic acid on the clinical resolution of Charcot neuroarthropathy: a pilot randomized controlled trial.

Publications

The effect of zoledronic acid on the clinical resolution of Charcot neuroarthropathy: a pilot randomized controlled trial.

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