Su.106. Clinical Effects of Intraarticular Injection of Polymerized-Type I Collagen: a Double-Blind, Randomized, Placebo-Controlled Trial

2006 ◽  
Vol 119 ◽  
pp. S196
Author(s):  
Janette Furuzawa-Carballeda ◽  
Andres Agualimpia-Janning ◽  
Olga Munoz-Chable ◽  
Salvador Macias-Hernandez
Keyword(s):  
Type I Collagen ◽  
Controlled Trial ◽  
Intraarticular Injection ◽  
Type I ◽  
Clinical Effects ◽  
Double Blind

scholarly journals Low-Dose Zoledronate in Osteopenic Postmenopausal Women: A Randomized Controlled Trial

2012 ◽  
Vol 97 (1) ◽  
pp. 286-292 ◽  
Author(s):  
Andrew Grey ◽  
Mark Bolland ◽  
Sumwai Wong ◽  
Anne Horne ◽  
Greg Gamble ◽  
...  
Keyword(s):  
Placebo Group ◽  
Confidence Interval ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Type I Collagen ◽  
Controlled Trial ◽  
Type I ◽  
Mineral Density ◽  
Double Blind ◽  
Skeletal Effects

Context: Annual iv administration of 5 mg zoledronate decreases fracture risk. The skeletal effects of annual treatment with doses of zoledronate under 4 mg have not been assessed. Objective: Our objective was to determine the skeletal effects of single doses of zoledronate of 5 mg or less. Design, Setting, and Participants: This was a double-blind, randomized, placebo-controlled trial over 1 yr at an academic research center in 180 postmenopausal women with osteopenia. Intervention: Intervention was a single baseline administration of iv zoledronate in doses of 1, 2.5, or 5 mg, or placebo. Main Outcome Measures: The primary endpoint was change in bone mineral density (BMD) at the lumbar spine. Secondary endpoints were change in BMD at the proximal femur and total body and changes in biochemical markers of bone turnover. Results: After 12 months, change in spine BMD was greater in each of the zoledronate groups than in the placebo group [mean (95% confidence interval) difference vs. placebo was 3.5% (2.2–4.8%) for 1 mg, 4.0% (2.7–5.3%) for 2.5 mg, and 3.6% (2.3–4.9%) for 5 mg zoledronate, P < 0.001 for each dose]. Change in BMD at the total hip was greater in each of the zoledronate groups than the placebo group [mean (95% confidence interval) difference vs. placebo was 2.7% (1.9–3.5%) for 1 mg, 3.6% (2.8–4.4%) for 2.5 mg, and 3.6% (2.8–4.4%) for 5 mg zoledronate, P < 0.001 for each dose]. Each of the bone turnover markers, β-C-terminal telopeptide of type I collagen and procollagen type I N-terminal propeptide, was lower by at least 40% in each of the zoledronate groups than the placebo group throughout the trial (P < 0.001 vs. placebo for each marker for each dose). There was evidence for a dose-dependent effect of zoledronate on each of the markers (P for trend <0.001). Conclusion: Annual administration of doses of iv zoledronate lower than 5 mg produces substantial antiresorptive effects. Trials assessing the antifracture efficacy of low doses of zoledronate are justified.

Double-blind controlled trial of azathioprine in children with newly diagnosed type I diabetes

Diabetes ◽  
1989 ◽  
Vol 38 (6) ◽  
pp. 779-783 ◽  
Author(s):  
J. J. Cook ◽  
I. Hudson ◽  
L. C. Harrison ◽  
B. Dean ◽  
P. G. Colman ◽  
...  
Keyword(s):  
Type I Diabetes ◽  
Controlled Trial ◽  
Type I ◽  
Newly Diagnosed ◽  
Double Blind

scholarly journals Effect of 12-weeks elastic band resistance training on MyomiRs and osteoporosis markers in elderly women with Osteosarcopenic obesity: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ebrahim Banitalebi ◽  
Majid Mardaniyan Ghahfarrokhi ◽  
Mortaza Dehghan
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Type I Collagen ◽  
Assessment Tool ◽  
Elderly Women ◽  
Controlled Trial ◽  
Type I ◽  
Elastic Band ◽  
Randomized Controlled ◽  
Osteosarcopenic Obesity

Abstract Background Interorgan communication networks established during exercise in several different tissues can be mediated by several exercise-induced factors. Therefore, the present study aimed to investigate the effects of resistance-type training using elastic band-induced changes of myomiRs (i.e., miR-206 and miR-133), vitamin D, CTX-I, ALP, and FRAX® score in elderly women with osteosarcopenic obesity (OSO). Methods In this randomized controlled trial, 63 women (aged 65–80 years) with Osteosarcopenic Obesity were recruited and assessed, using a dual-energy X-ray absorptiometry instrument. The resistance-type training via elastic bands was further designed three times per week for 12-weeks. The main outcomes were Fracture Risk Assessment Tool score, bone mineral content, bone mineral density, vitamin D, alkaline phosphatase, C-terminal telopeptides of type I collagen, expression of miR-206 and miR-133. Results There was no significant difference between the study groups in terms of the Fracture Risk Assessment Tool score (p = 0.067), vitamin D (p = 0.566), alkaline phosphatase (p = 0.334), C-terminal telopeptides of type I collagen (p = 0.067), microR-133 (p = 0.093) and miR-206 (p = 0.723). Conclusion Overall, the results of this study illustrated 12-weeks of elastic band resistance training causes a slight and insignificant improvement in osteoporosis markers in women affected with Osteosarcopenic Obesity. Trial registration Randomized controlled trial (RCT) (Iranian Registry of Clinical Trials, trial registration number: IRCT20180627040260N1. Date of registration: 27/11/2018.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

The research evidence base for homeopathy: a fresh assessment of the literature

Homeopathy ◽  
2003 ◽  
Vol 92 (02) ◽  
pp. 84-91
Author(s):  
RT Mathie
Keyword(s):  
Clinical Trials ◽  
Research Evidence ◽  
Controlled Trial ◽  
Relative Number ◽  
Evidence Base ◽  
Weight Of Evidence ◽  
Clinical Effects ◽  
Upper Respiratory Tract ◽  
Medical Conditions ◽  
Double Blind

Abstract Background. The claims made for the clinical effects of homeopathy are controversial. The results of several meta-analyses of clinical trials are positive, but they fail in general to highlight specific medical conditions that respond well to homeopathy. Aims. This review examines the cumulative research from randomised and/or double-blind clinical trials (RCTs) in homeopathy for individual medical conditions reported since 1975, and asks the question: What is the weight of the original evidence from published RCTs that homeopathy has an effect that is statistically significantly different from that in a comparative group? Method. Analysis of the 93 substantive RCTs that compare homeopathy either with placebo or another treatment. Results. 50 papers report a significant benefit of homeopathy in at least one clinical outcome measure, 41 that fail to discern any inter-group differences, and two that describe an inferior response with homeopathy. Considering the relative number of research articles on the 35 different medical conditions in which such research has been carried out, the weight of evidence currently favours a positive treatment effect in eight: childhood diarrhoea, fibrositis, hayfever, influenza, pain (miscellaneous), side-effects of radio- or chemotherapy, sprains and upper respiratory tract infection. Based on published research to date, it seems unlikely that homeopathy is efficacious for headache, stroke or warts. Insufficient research prevents conclusions from being drawn about any other medical conditions. Conclusions. The available research evidence emphasises the need for much more and better-directed research in homeopathy. A fresh agenda of enquiry should consider beyond (but include) the placebo-controlled trial. Each study should adopt research methods and outcome measurements linked to a question addressing the clinical significance of homeopathy's effects.

scholarly journals Coated-tube radioimmunoassay for C-telopeptides of type I collagen to assess bone resorption

1996 ◽  
Vol 42 (10) ◽  
pp. 1639-1644 ◽  
Author(s):  
M Bonde ◽  
C Fledelius ◽  
P Qvist ◽  
C Christiansen
Keyword(s):  
Bone Resorption ◽  
Postmenopausal Women ◽  
Type I Collagen ◽  
Premenopausal Women ◽  
Type I ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Analytical Recovery ◽  
Controlled Clinical Study ◽  
Different Doses

Abstract We present a coated-tube RIA that is useful for assessment of bone resorption. The assay uses a monoclonal antibody raised against a linear 8-amino-acid sequence (EKAHDGGR) derived from the C-telopeptides of type I collagen. Within-run and total CVs were 4.4% and 5.3-6.2%, respectively, at concentrations of 1-7 mg/L (n = 4-20). Analytical recovery was 98% +/- 8% and dilution 97% +/- 7%. Values obtained in a group of 36 premenopausal women were 227 +/- 89.6 mg/mol creatinine. In a group of 141 postmenopausal women, the values obtained were 429 +/- 225 mg/mol creatinine, a highly significant increase of 89% (P <0.001) over the premenopausal value. In a double-blind placebo-controlled clinical study of these postmenopausal women receiving five different doses of a bisphosphonate, a significant decrease of RIA-measured C-telopeptide values was seen in all bisphosphonate-treated groups, after just 3 months. Values in urine samples from postmenopausal women assayed with the RIA (gamma) and the CrossLaps(TM) ELISA (x) agreed well: slope = 0.98 (95% confidence interval, 0.94-1.01), intercept = 0.34 (0.25-0.43) mg/L, and Sylx = 0.93 mg/L (n = 678). We conclude that this RIA represents a valuable tool for assessing bone resorption.

Effects of everolimus (EVE) on disease progression in bone and bone markers (BMs) in patients (pts) with bone metastases (mets).

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 102-102 ◽  
Author(s):  
Lowell L. Hart ◽  
José Baselga ◽  
Hope S. Rugo ◽  
Shinzaburo Noguchi ◽  
Kathleen I. Pritchard ◽  
...  
Keyword(s):  
Bone Turnover ◽  
Type I Collagen ◽  
Bone Lesion ◽  
Phase Iii ◽  
Type I ◽  
Double Blind ◽  
Mtor Inhibition ◽  
Similar Frequency ◽  
Once Daily ◽  
Amino Terminal

102 Background: BOLERO-2, a multinational, double-blind, placebo-controlled, phase III study in postmenopausal women with estrogen-receptor–positive breast cancer (BC) refractory to nonsteroidal aromatase inhibitors (NSAIs), showed significant clinical benefits with the addition of EVE to exemestane (EXE) (Baselga J et al. NEJM2011 Epub). As bone resorption is an important factor in BC mets, it is interesting to study bone-related effects of EVE. In preclinical studies, mTOR inhibition was associated with decreased osteoclast survival and activity. Exploratory analyses in BOLERO-2 evaluated the effects of EVE vs placebo (PBO) on BM levels and BC progression in bone in pts with bone mets at baseline. Methods: Eligible pts were treated with EXE (25 mg once daily) and randomized (2:1) to EVE (10 mg once daily) or PBO. Bone turnover markers (BMs) were exploratory endpoints analyzed at 6 and 12 wks after treatment initiation and included bone-specific alkaline phosphatase, amino-terminal propeptide of type I collagen, and C-terminal cross-linking telopeptide of type I collagen. Progressive disease in bone (PDB) was defined as worsening of a preexisting bone lesion or a new bone lesion. Results: Baseline disease characteristics, including bone mets at baseline (n = 370, 76% EVE vs n = 184, 77% PBO), were well balanced between arms (N = 724), and baseline bisphosphonate use was not (44% EVE vs 55% PBO). At 12.5 mo median follow-up, progression-free survival (primary endpoint), overall response rate, and clinical benefit rate (p < 0.0001, all) were significantly higher with EVE (n = 485) vs PBO (n = 239). BM levels at 6 and 12 wks increased vs baseline with PBO but decreased with EVE. The cumulative incidence rate of BC PBD was lower for EVE vs PBO at day 60 (3.03% vs 6.16%, respectively), and this trend was sustained beyond 6 months. Updated results will be presented. All bone-related adverse events reported were grade 1-2 and occurred with similar frequency in EVE (2.9%)- and PBO (3.8%)-treated patients. Conclusions: Exploratory analyses from BOLERO-2 suggest that adding EVE has beneficial effects on bone turnover and BC progression in bone in pts receiving EXE therapy for NSAI-refractory BC.

scholarly journals Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246871
Author(s):  
Timna Naftali ◽  
Lihi Bar-Lev Schleider ◽  
Fabiana Scklerovsky Benjaminov ◽  
Fred Meir Konikoff ◽  
Shelly Tartakover Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Placebo Group ◽  
Activity Index ◽  
Controlled Trial ◽  
Clinical Effects ◽  
Short Term Treatment ◽  
Double Blind ◽  
Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

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