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38 publications found
December 07, 2022
Source Data Verification (SDV) has been reported to account for up to 25% of the budget in Clinical Trials (CT) and cost-benefit of SDV has been questioned. Guidelines for Risk-Based Monitoring (RBM) were published in 2013 by agencies and in 2016, ICH-GCP-E6-(R2) added a requirement for risk-based approaches. This report will perform a comparison of the impact of RBM versus Classic Monitoring (CM) on data quality (defined as accuracy of data reporting from source data to final trial data) and expected impact on costs of CTs.
Journals:British Journal of Clinical Pharmacology
Clinical Data Quality
August 21, 2022
What is the central question in this study? Atrial natriuretic peptide (ANP) is secreted in response to atrial wall distension and thus allows for evaluation, albeit indirect, of the central blood volume. Adrenaline has chronotropic and inotropic effects. We evaluated whether the chronotropic and inotropic effects of adrenaline were reflected in mid-regional proANP. What is the main finding and its importance? Central blood volume remained stable with infusion of adrenaline and yet mid-regional proANP increased. Thus, the chronotropic and inotropic state of the heart or adrenaline directly induces release of ANP variants from the myocytes.
August 05, 2022
Associations between single-question Visual Analogue Scale pain score and weight-bearing and non-weight-bearing domains of Western Ontario and McMaster Universities Arthritis Index pain: data from 2 phase 3 clinical trials
The objective of this cross-sectional study was to explore the associations between single-question VAS pain and the weight-bearing and non-weight-bearing domains of WOMAC pain. Data from 2093 patients with OA participating in 2 phase 3 clinical trials were included for post hoc analyses. Univariate Pearson correlations and comparison of r values were made using z statistics obtained using the Fisher r to z test for all items of the VAS pain scale, the WOMAC pain subscale, the weight-bearing and non-weight-bearing constructs of WOMAC pain subscale, and by subgroups of WOMAC pain quintiles and Kellgren-Lawrence grades.
Bjerre-Bastos JJ , Miller CP , Li Y , Andersen JR , Karsdal MA , Bihlet AR
July 22, 2022
An Estimate of Plasma Volume Changes Following Moderate-High Intensity Running and Cycling Exercise and Adrenaline Infusion
Plasma volume (PV) changes in response to physical activity, possibly as a consequence of adrenergic activation. We estimated changes in PV in response to common exercise modalities; cycling and running as well as adrenaline infusion and control at rest.
Journals:Frontiers in Physiology
Bjerre-Bastos JJ , Sejersen C , Bihlet AR , Secher NH , Mackey AL , Kitchen CC , Drobinski P , Thudium CS , Nielsen HB
February 25, 2022
Symptomatic and structural benefit of cathepsin K inhibition by MIV-711 in a subgroup with unilateral pain: post-hoc analysis of a randomised phase 2a clinical trial
Osteoarthritis (OA) development programmes face challenges due to discordance between structural changes and symptoms. A novel cathepsin-K inhibitor, MIV-711, recently reported structural benefits, but did not demonstrate a significant difference from placebo in symptoms. Previous work suggests that pain from non-target joints may confound OA pain outcomes. We therefore conducted an exploratory analysis in participants with predominantly unilateral knee pain from the MIV-711-201 trial.
Journals:Clinical and Experimental Rheumatology
Bihlet AR , Byrjalsen I , Andersen JR , Ôberg F , Herder C , Bowea MA , Conaghan PG
October 22, 2021
The efficacy and safety of multiple dose regimens of Kudzu root (Pueraria lobata) extract on bone and cartilage turnover and menopausal symptoms
This clinical trial evaluates the efficacy on bone and cartilage turnover, menopausal symptoms, and safety of five dose regimens of Kudzu root extract administered either once, twice or three times daily in women with at least mild menopausal symptoms.
Journals:Frontiers in Pharmacology
Bihlet AR , Byrjalsen I , Simonsen SF , Mundbjerg K , Helmer BR , Riis BJ , Karsdal MA , Christiansen C
June 22, 2021
A biomarker perspective on the acute effect of exercise with and without impact on joint tissue turnover: an exploratory randomized cross-over study
To investigate acute changes in biochemical markers of bone and cartilage turnover in response to moderate intensity exercise with and without joint impact in healthy human subjects.
Journals:European Journal of Applied Physiology
Bjerre-Bastos JJ , Nielsen HB , Andersen JR , Karsdal MA , Boesen M , Mackey AL , Byrjalsen I , Thudium CS , Bihlet AR
June 18, 2021
There is a need for antidiabetic agents successfully targeting insulin sensitivity and treating obesity control at the same time. The aim of this first-in-human study was (a) to evaluate safety and tolerability, (b) to evaluate pharmacokinetics and (c) to assess indications of receptor engagement of single ascending doses of KBP-042, a dual amylin and calcitonin receptor agonist (DACRA) that has shown promising preclinical data, with superior activity in terms of typical amylin-induced responses including reduction of food intake, weight loss and gluco-regulatory capacities.
Journals:British Journal of Clinical Pharmacology
Henriksen K , Broekhuizen K , de Boon WMI , Karsdal MA , Bihlet AR , Christiansen C , Dillingh MR , de Kam M , Kumar R , Burggraaf J , Kamerling IMC
May 07, 2021
Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study
The FORWARD (FGF-18 Osteoarthritis Randomized Trial with Administration of Repeated Doses) trial assessed efficacy and safety of the potential disease-modifying osteoarthritis drug (DMOAD) sprifermin in patients with knee osteoarthritis. Here, we report 5-year efficacy and safety results.
Journals:Annals of the Rheumatic Diseases
Eckstein F , Hochberg MC , Guehring H , Moreau F , Ona V , Bihlet AR , Byrjalsen I , Andersen JR , Daelken B , Guenther O , Ladel C , Michaelis M , Conaghan PG
March 22, 2021
Serum C-reactive protein metabolite (CRPM) is associated with incidence of contralateral knee osteoarthritis
The heterogeneous nature of osteoarthritis (OA) and the need to subtype patients is widely accepted in the field. The biomarker CRPM, a metabolite of C-reactive protein (CRP), is released to the circulation during inflammation. Blood CRPM levels have shown to be associated with disease activity and response to treatment in rheumatoid arthritis (RA). We investigated the level of blood CRPM in OA compared to RA using data from two phase III knee OA and two RA studies (N = 1591).
Bay-Jensen AC , Bihlet AR , Byrjalsen I , Andersen JR , Riis BJ , Christiansen C , Michaelis M , Guehring H , Ladel C , Karsdal MA