Does moderate intensity impact exercise and non-impact exercise induce acute changes in collagen biochemical markers related to osteoarthritis? - An exploratory randomized cross-over trial
ABSTRACT
Objective: To investigate acute changes in biochemical markers of cartilage turnover in response to moderate intensity exercise with and without joint impact in humans with knee osteoarthritis.
Design: We conducted a randomized, cross-over, exploratory clinical study. Twenty subjects wi…
Journal:
Authors:
- Bjerre-Bastos JJ,
- Nielsen HB,
- Andersen JR,
- Karsdal MA,
- Bay-Jensen AC,
- Boesen M,
- Mackey AL,
- Byrjalsen I,
- Bihlet AR,
Long-term structural and symptomatic effects of intra-articular sprifermin in patients with knee osteoarthritis: 5-year results from the FORWARD study
ABSTRACT
Objective: 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 safet…
Journal:
Authors:
- 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,
The effects of sprifermin on symptoms and structure in a subgroup at risk of progression in the FORWARD knee osteoarthritis trial
ABSTRACT
Objective: To assess pain outcomes and cartilage thickness change in a subgroup at risk (SAR) of further progression in the FORWARD trial of knee osteoarthritis patients treated with sprifermin.
Methods: Patients were randomised 1:1:1:1:1 to: sprifermin 100 µg every 6 months (q6mo), 100…
Journal:
Authors:
- Guehring H,
- Moreau F,
- Daelken B,
- Ladel C,
- Guenther O,
- Bihlet AR,
- Wirth W,
- Eckstein F,
- Hochberg M,
- Conaghan PG,
Serum C-reactive protein metabolite (CRPM) is associated with incidence of contralateral knee osteoarthritis
ABSTRACT
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 act…
Journal:
Authors:
- Bay-Jensen AC,
- Bihlet AR,
- Byrjalsen I,
- Andersen JR,
- Riis BJ,
- Christiansen C,
- Michaelis M,
- Guehring H,
- Ladel C,
- Karsdal MA,
A novel diclofenac gel (AMZ001) applied once or twice daily in subjects with painful knee osteoarthritis: A randomized, placebo-controlled clinical trial
ABSTRACT
Purpose: Osteoarthritis Research Society International (OARSI) Expert Consensus Guidelines recommend topical non-steroidal anti-inflammatory drugs as first-line medications for osteoarthritis (OA) knee pain, but several voluminous daily applications are required to achieve efficacy. There …
Journal:
Authors:
- Bihlet AR,
- Byrjalsen I,
- Simon LS,
- Carrara D,
- Delpy L,
- Derne C,
Clinical and Biochemical Factors Associated With Risk of Total Joint Replacement and Radiographic Progression in Osteoarthritis: Data From Two Phase III Clinical Trials
ABSTRACT
Objectives: Clinical trials of new disease-modifying treatments for osteoarthritis should demonstrate a positive effect on a functional outcome or reduction in joint failure in order to be considered successful. Total joint replacement (TJR) surgery may be considered as joint failure, but …
Journal:
Authors:
- Bihlet AR,
- Bjerre-Bastos JJ,
- Andersen JR,
- Byrjalsen I,
- Karsdal MA,
- Bay-Jensen AC,
Evaluation of serum ARGS neoepitope as an osteoarthritis biomarker using a standardized model for exercise-induced cartilage extra cellular matrix turnover
OBJECTIVE
To propose a standardized model for exercise-induced cartilage turnover and investigate residual levels and dynamics of biomarker serum ARGS (sARGS) in primary osteoarthritis (OA) patients and a supportive group of young healthy subjects.
METHOD
The trial is a randomized, cross-over, …
Journal:
Authors:
- Bjerre-Bastos JJ,
- Nielsen HB,
- Andersen JR,
- He Y,
- Karsdal MA,
- Bay-Jensen AC,
- Boesen M,
- Mackey AL,
- Bihlet AR,
The acute and long-term impact of physical activity on biochemical markers and MRI measures in osteoarthritis - Perspectives for clinical osteoarthritis research
We aimed to investigate existing literature on the impact of physical activity and exercise (PA) on joint biochemical markers (BM) and magnetic resonance imaging (MRI) outcomes in osteoarthritis (OA), and on this basis propose directions for future research. Literature Review. Original papers were i…
Journal:
Authors:
- Bjerre-Bastos JJ,
- Karsdal MA,
- Boesen M,
- Bliddal H,
- Bay-Jensen AC,
- Andersen JR,
- Bihlet AR,
Effect of Intra-Articular Sprifermin vs Placebo on Femorotibial Joint Cartilage Thickness in Patients With Osteoarthritis: The FORWARD Randomized Clinical Trial.
ABSTRACT
Importance: Sprifermin is under investigation as a disease-modifying osteoarthritis drug.
Objective: To evaluate the effects of sprifermin on changes in total femorotibial joint cartilage thickness in the more symptomatic knee of patients with osteoarthritis.
Design, setting, and par…
Journal:
Authors:
- Hochberg MC,
- Guermazi A,
- Guehring H,
- Aydemir A,
- Wax S,
- Fleuranceau-Morel P,
- Bihlet AR,
- Byrjalsen I,
- Andersen JR,
- Eckstein F,
Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis.
ABSTRACT
Background: Excessive cartilage degradation is a known characteristic of osteoarthritis (OA). Biochemical markers, such as uCTX-II, have been shown to be associated with disease severity, yet the tissue origin of CTX-II has been disputed. This analysis investigates the association between …
Journal:
Authors:
- Bihlet AR,
- Byrjalsen I,
- Bay-Jensen AC,
- Andersen JR,
- Christiansen C,
- Riis BJ,
- Karsdal MA,
Incidence of total hip and total knee replacements from the prospective epidemiologic risk factor study: considerations for event driven clinical trial design
ABSTRACT
Background: Osteoarthritis (OA) leads to joint failure and total joint replacement (TJR, either hip (H) or knee (K)). Worsening of pain and joint space narrowing are believed to be surrogates for joint failure; however, we hypothesize that TJR, as a reflection of joint failure, can be used…
Journal:
Authors:
- Bager CL,
- Karsdal MA,
- Bihlet AR,
- Thudium CS,
- Byrjalsen I,
- Bay-Jensen AC,
Protein biomarkers associated with pain mechanisms in osteoarthritis
ABSTRACT
Background: Osteoarthritis (OA) is the most common arthritic disease in the world, leading to debilitating pain and destruction of joint tissues. While pain is the hallmark symptom of osteoarthritis, clear associations between pain and disease processes involved in joint deterioration are …
Journal:
Authors:
- Thudium CS,
- Löfvall H,
- Karsdal MA,
- Bay-Jensen AC,
- Bihlet AR,
Identification of pain categories associated with change in pain in patients receiving placebo: Data from Two Phase 3 Randomized Clinical Trials in Symptomatic Knee Osteoarthritis
ABSTRACT
Background: Pain is the principal clinical symptom of osteoarthritis (OA), and development of safe and effective analgesics for OA pain is needed. Drug development of new analgesics for OA pain is impaired by substantial change in pain in patients receiving placebo, and more data describin…
Journal:
Authors:
- Bihlet AR,
- Byrjalsen I,
- Bay-Jensen AC,
- Andersen JR,
- Christiansen C,
- Riis BJ,
- Valter I,
- Karsdal MA,
- Hochberg MC,
Disease-modifying treatments for osteoarthritis (DMOADs) of the knee and hip: lessons learned from failures and opportunities for the future
ABSTRACT
Osteoarthritis (OA) is the biggest unmet medical need among the many musculoskeletal conditions and the most common form of arthritis. It is a major cause of disability and impaired quality of life in the elderly. We review several ambitious but failed attempts to develop joint structure-m…
Journal:
Authors:
- Karsdal MA,
- Michaelis M,
- Ladel C,
- Siebuhr AS,
- Bihlet AR,
- Andersen JR,
- Guehring H,
- Christiansen C,
- Bay-Jensen AC,
- Kraus VB,
Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials
ABSTRACT
Purpose: To evaluate the structure-modifying and symptom efficacy, as well as safety and tolerability of oral salmon calcitonin (sCT) formulated with a 5-CNAC carrier (a molecule based on Eligen(®) technology), in osteoarthritis (OA) patients with moderate to severe knee pain and joint str…
Journal:
Authors:
- Karsdal MA,
- Byrjalsen I,
- Alexandersen P,
- Bihlet AR,
- Andersen JR,
- Riis BJ,
- Bay-Jensen AC,
- Christiansen C,
- CSMC021C301/1 investigators,
OA phenotypes, rather than disease stage, drive structural progression--identification of structural progressors from 2 phase III randomized clinical studies with symptomatic knee OA
ABSTRACT
Background: The aim of this study was to identify key characteristics of disease progression through investigation of the association of radiographic progression over two years with baseline Joint Space Width (JSW), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Ar…
Journal:
Authors:
- Karsdal MA,
- Bihlet AR,
- Byrjalsen I,
- Alexandersen P,
- Ladel C,
- Michaels M,
- Andersen JR,
- Riis BJ,
- Kraus V,
- Bay-Jensen AC,
- Christiansen C,