scholarly journals A placebo-controlled study of three osteocalcin assays for assessment of prednisolone-induced suppression of bone turnover

1998 ◽  
Vol 159 (1) ◽  
pp. 127-131 ◽  
Author(s):  
C Heuck ◽  
OD Wolthers
Keyword(s):  
Bone Turnover ◽  
Premenopausal Women ◽  
Controlled Study ◽  
Serum Osteocalcin ◽  
Double Blind ◽  
Prednisolone Treatment ◽  
Parallel Group ◽  
The Individual ◽  
Oral Glucocorticoids ◽  
Sensitive Marker

Serum osteocalcin is a sensitive marker of suppressive effects of exogenous glucocorticoids on bone turnover. It has been suggested, however, that the degree of suppression detected by different assays may vary. Whether discrepancies between various assays influence conclusions from group studies of exogenous glucocorticoids has not been evaluated. The aim of the present study was to compare the CAP fluoroimmunoassay (FEIA), OSTK-PR and ELSA-OSTEO assays for assessment of prednisolone-induced effects on serum osteocalcin. Twelve men and eight premenopausal women aged 19-45 (mean 31) years were studied. All subjects were healthy. The design was a randomised double-blind, placebo-controlled parallel- group study with 2 days run-in, 3 days treatment and 4 days run-out. During run-in and run-out no medication was given. During the treatment period the subjects took either 20 mg prednisolone twice daily or placebo. Blood was collected on the last day of each period. Intra- and intergroup comparisons showed prednisolone treatment to be associated with a statistically significant suppression of osteocalcin which was detected by all assays (ANOVA;P<0.0001). In the individual subjects the response to prednisolone was the same for each assay. The CAP FEIA, OSTK-PR and ELSA-OSTEO assays seem equally sensitive for evaluation of osteocalcin in group studies of oral glucocorticoids.

A simple enzyme-linked immunosorbent assay of human osteocalcin

1994 ◽  
Vol 40 (7) ◽  
pp. 1258-1264 ◽  
Author(s):  
C Rosenquist ◽  
M Bonde ◽  
C Fledelius ◽  
P Qvist
Keyword(s):  
Postmenopausal Women ◽  
Polyclonal Antibodies ◽  
Premenopausal Women ◽  
Controlled Study ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Osteocalcin ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Early Postmenopausal Women ◽  
Log Linear

Abstract A heterologous ELISA for measurement of osteocalcin (bone Gla-protein) is described, involving biotinylated bovine osteocalcin and polyclonal antibodies. The log-linear range was 2.3-37.5 micrograms/L. Between-run (total) and within-run CVs (n = 10) were 5.7-6.4 and 5.9-6.1%, respectively; analytical recoveries ranged from 92% to 108%. Comparison of our method (x) with an RIA (y) yielded y = 1.10 x -0.01 microgram/L, Sylx = 1.4 micrograms/L, r = 0.958 (n = 167). Serum osteocalcin in healthy premenopausal women (n = 29) was 8.7 +/- 3.3 micrograms/L (mean +/- SD) and 11.8 +/- 4.5 micrograms/L in early-postmenopausal women (n = 24). The assay was evaluated in a double-blind placebo-controlled study of healthy early-postmenopausal women, treated for 12 months with either (a) estrogen valerate plus medroxyprogesterone acetate (n = 18), (b) 17 beta-estradiol and desogestrel (n = 22), or (c) placebo (n = 17). Serum osteocalcin decreased significantly (P &lt; 0.001) with either therapy, but increased (P &lt; 0.05) with placebo.

scholarly journals Effectiveness of brushing teeth in patients with reduced oral hygiene by laypeople: a randomized, controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anna Greta Barbe ◽  
Aya Al-Barwari ◽  
Stefanie Hamacher ◽  
Renate Deinzer ◽  
Ulrike Weik ◽  
...  
Keyword(s):  
Oral Hygiene ◽  
Group Intervention ◽  
Controlled Study ◽  
Care Gap ◽  
Parallel Group ◽  
Dental Professional ◽  
The Individual ◽  
Time Required ◽  
Powered Toothbrush ◽  
Dental Professionals

Abstract Background To evaluate the success of plaque reduction after external toothbrushing by instructed laypeople versus dental professionals using either a manual or powered toothbrush. Longitudinal, randomized, parallel-group intervention study in periodontitis patients with reduced oral hygiene quality undergoing anti-infective therapy. Patients were randomly and equally assigned to one of four groups: laypeople using a manual or powered toothbrush or dental professionals using a manual or powered toothbrush. Plaque reduction (Quigley–Hein-Index (QHI), Marginal Plaque Index (MPI)), gingivitis (papilla bleeding index), and cleaning time (seconds) were investigated. Results Thirty-nine patients participated in the study. Neither the choice of toothbrush (p = 0.399) nor the use of a dental professional (p = 0.790) had a significant influence on plaque levels achieved. However, multivariate modeling indicated statistically significant differences in the external cleaning time between brushing groups, with longer time required by laypeople (p = 0.002) and longer use of the powered toothbrush (p = 0.024). Conclusion When the ability to carry out personal oral hygiene is reduced, external brushing by dental professionals or instructed laypeople who meet previously defined criteria such as sufficient personal oral hygiene at home could help to fill the emerging dental care gap. A combination of oral hygiene approaches adapted to the individual needs of the patients in need of external help is necessary for optimum oral hygiene. Trial registration: German Clinical Trials register (https://www.germanctr.de; number DRKS00018779; date of registration 04/11/2019).

Acetyl L-Carnitine Slows Decline in Younger Patients With Alzheimer's Disease: A Reanalysis of a Double-Blind, Placebo-Controlled Study Using the Trilinear Approach

1998 ◽  
Vol 10 (2) ◽  
pp. 193-203 ◽  
Author(s):  
John O. Brooks ◽  
Jerome A. Yesavage ◽  
Angelico Carta ◽  
Daniele Bravi
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Average Rate ◽  
The United States ◽  
Rate Of Change ◽  
Disease Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Parallel Group ◽  
Longitudinal Effects

Objectives: To assess the longitudinal effects of acetyl-L-carnitine (ALC) on patients diagnosed with Alzheimer's disease. Design: Longitudinal, double-blind, parallel-group, placebocontrolled. Setting: Twenty-four outpatient sites across the United States. Participants: A total of 334 subjects diagnosed with probable Alzheimer's disease by NINCDS-ADRDA criteria. These data were originally reported by Thal and colleagues (1996). Measurements: Cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS) given every 3 months for 1 year. Results: The average rate of change was estimated using the trilinear approach, which allows for periods of both change and stability. Both the ALC group and the placebo group exhibited the same mean rate of change on the ADAS (0.68 points/month). However, a multiple regression analysis revealed a statistically significant Age × Drug interaction characterized by younger subjects benefiting more from ALC treatment than older subjects. Further analyses suggested that the optimal, though not statistically significant, cutpoint for ALC benefit was 61 years of age. Conclusions: ALC slows the progression of Alzheimer's disease in younger subjects, and the use of the trilinear approach to estimate the average rate of change may prove valuable in pharmacological trials.

scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

Oral laquinimod in patients with relapsing-remitting multiple sclerosis: 36-week double-blind active extension of the multi-centre, randomized, double-blind, parallel-group placebo-controlled study

2010 ◽  
Vol 16 (11) ◽  
pp. 1360-1366 ◽  
Author(s):  
G. Comi ◽  
O Abramsky ◽  
T Arbizu ◽  
A Boyko ◽  
R Gold ◽  
...  
Keyword(s):  
Liver Enzymes ◽  
Extension Phase ◽  
Controlled Study ◽  
Safety Signal ◽  
Double Blind ◽  
Clinical Assessments ◽  
Parallel Group ◽  
Relapsing Remitting ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Efficacy Profile

Background: Laquinimod, an oral novel immunomodulator, was shown to reduce MRI-measured disease activity in relapsing—remitting MS (RRMS) patients. Objectives: To determine whether the safety and efficacy profile of laquinimod, as shown in a placebo-controlled 36-week trial (LAQ/5062), is sustained and reproducible. Methods: Two hundred and fifty seven patients entered the extension phase in which MRI was performed at the beginning and at the end of the active extension phase. Clinical assessments were performed at weeks 4, 12 and every 12 weeks thereafter. Results: Two hundred and thirty nine (93%) patients completed the extension phase and 222 (86.3%) had a final scan available. Gadolinium-enhanced (GdE) T1 lesions were significantly reduced for patients switching from placebo to 0.3/ 0.6 mg doses (52%, p = 0.0006). In patients initially randomized to 0.6 mg in LAQ/5062 the reduction of MRI activity observed in the placebo-controlled phase was maintained in the extension. The proportion of GdE-free patients for those who switched from placebo increased from a baseline of 31% to 47% at the end of the extension phase ( p = 0.01). The most prominent safety signal was elevations of liver enzymes, reversible in all cases. Conclusions: The good efficacy and the excellent safety and tolerability profiles of laquinimod 0.6 mg/day are confirmed in this extension study.

scholarly journals Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study

2018 ◽  
Vol 37 (6) ◽  
pp. 1862-1870 ◽  
Author(s):  
Lee-Jane W. Lu ◽  
Nai-Wei Chen ◽  
Fatima Nayeem ◽  
V-M. Sadagopa Ramanujam ◽  
Yong-Fang Kuo ◽  
...  
Keyword(s):  
Serum Calcium ◽  
Premenopausal Women ◽  
Soy Isoflavones ◽  
Controlled Study ◽  
Double Blind
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