scholarly journals BIOMARKERS OF SARCOPENIA IN CLINICAL TRIALS RECOMMENDATIONS FROM THE INTERNATIONAL WORKING GROUP ON SARCOPENIA

2012 ◽  
pp. 1-9
Author(s):  
M. CESARI ◽  
R.A. FIELDING ◽  
M. PAHOR ◽  
B. GOODPASTER ◽  
M. HELLERSTEIN ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Clinical Trials ◽  
Working Group ◽  
Task Force ◽  
Scientific Progress ◽  
Health Priorities ◽  
International Working Group ◽  
Age Related ◽  
The Subject ◽  
Preliminary Phase

Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the results of a recent meeting of the International Working Group on Sarcopenia (a task force consisting of geriatricians and scientists from academia and industry) held on June 7-8, 2011 in Toulouse (France). The meeting was specifically focused at gaining knowledge on the currently available biomarkers (functional, biological, or imaging-related) that could be utilized in clinical trials of sarcopenia and considered the most reliable and promising to evaluate age-related modifications of skeletal muscle. Specific recommendations about the assessment of aging skeletal muscle in older people and the optimal methodological design of studies on sarcopenia were also discussed and finalized. Although the study of skeletal muscle decline is still in a very preliminary phase, the potential great benefits derived from a better understanding and treatment of this condition should encourage research on sarcopenia. However, the reasonable uncertainties (derived from exploring a novel field and the exponential acceleration of scientific progress) require the adoption of a cautious and comprehensive approach to the subject.

SARCOPENIA: HAVE WE REACHED THE CONSENSUS?

2012 ◽  
pp. 1-4
Author(s):  
L.-K. CHEN
Keyword(s):  
Clinical Trials ◽  
Older People ◽  
Working Group ◽  
Physical Disabilities ◽  
Adverse Outcomes ◽  
Economic Losses ◽  
International Consensus ◽  
International Working Group ◽  
Age Related ◽  
The Impact

Sarcopenia, the age-related loss of skeletal muscle mass, may cause substantial social and economic losses due to its associations with a number of adverse outcomes in the older people, such as falls, hip fractures, physical disabilities, institutionalizations and death (1-5). Although the impact of sarcopenia to the health of older people has been demonstrated, extensive research works are still needed to reach an international consensus with regard to its diagnosis and treatment. The International Working Group of Sarcopenia successfully invited geriatricians and scientists in this domain and formulated recommendations for clinical trials of sarcopenia in Toulouse, France (6). The International Working Group of Sarcopenia reviewed current evidences in definitions, diagnosis, biomarkers and clinical implications of sarcopenia, to provide some critical information for the study design of clinical trials of sarcopenia. Although the International Working Group of Sarcopenia has developed consensus in many dimensions of clinical trials of sarcopenia, some controversies remained unclear still which deserve more works in the future. Some controversies were summarized as below:

Neurodegenerative Diseases

2016 ◽  
Author(s):  
Jeffrey L. Cummings ◽  
Jagan A. Pillai
Keyword(s):  
Clinical Trials ◽  
Neurodegenerative Diseases ◽  
Protein Misfolding ◽  
Scientific Progress ◽  
Neuronal Loss ◽  
Therapeutic Interventions ◽  
Growth Factor Signaling ◽  
Age Related ◽  
Human Ips Cells ◽  
Neuropsychiatric Manifestations

Neurodegenerative diseases (NDDs) are growing in frequency and represent a major threat to public health. Advances in scientific progress have made it clear that NDDs share many underlying processes, including shared intracellular mechanisms such as protein misfolding and aggregation, cell-to-cell prion-like spread, growth factor signaling abnormalities, RNA and DNA disturbances, glial cell changes, and neuronal loss. Transmitter deficits are shared across many types of disorders. Means of studying NDDs with human iPS cells and transgenic models are similar. The progression of NDDs through asymptomatic, prodromal, and manifest stages is shared across disorders. Clinical features of NDDs, including cognitive impairment, disease progression, age-related effects, terminal stages, neuropsychiatric manifestations, and functional disorders and disability, have many common elements. Clinical trials, biomarkers, brain imaging, and regulatory aspects of NDD can share information across NDDs. Disease-modifying and transmitter-based therapeutic interventions, clinical trials, and regulatory approaches to treatments for NDDs are also similar.

scholarly journals DESIGNING DRUG TRIALS FOR SARCOPENIA IN OLDER ADULTS WITH HIP FRACTURE – A TASK FORCE FROM THE INTERNATIONAL CONFERENCE ON FRAILTY AND SARCOPENIA RESEARCH (ICFSR)

2014 ◽  
pp. 1-6
Author(s):  
B. VELLAS ◽  
R. FIELDING ◽  
R. MILLER ◽  
Y. ROLLAND ◽  
S. BHASIN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hip Fracture ◽  
Diagnostic Criteria ◽  
Task Force ◽  
National Institutes Of Health ◽  
Pharmaceutical Companies ◽  
Working Definition ◽  
Age Related ◽  
Increased Risk ◽  
Definition Of

In May 2012, a Sarcopenia Consensus Summit was convened by the Foundation of the National Institutes of Health (FNIH), National Institute of Aging (NIA), and the U.S. Food and Drug Administration (FDA); and co-sponsored by five pharmaceutical companies. At this summit, sarcopenia experts from around the world worked to develop agreement on a working definition of sarcopenia, building on the work of previous efforts to generate a consensus. With the ultimate goal of improving function and independence in individuals with sarcopenia, the Task Force focused its attention on people at greatly increased risk of muscle atrophy as a consequence of hip fracture. The rationale for looking at this population is that since hip fracture is a recognized condition, there is a clear regulatory path forward for developing interventions. Moreover, patients with hip fracture may provide an appropriate population to advance understanding of sarcopenia, for example helping to define diagnostic criteria, develop biomarkers, understand the mechanisms that underlie the age-related loss of muscle mass and strength, and identify endpoints for clinical trials that are reliable, objective, and clinically meaningful. Task Force members agreed that progress in treating sarcopenia will require strengthening of partnerships between academia, industry, and government agencies, and across continents to reach consensus on diagnostic criteria, optimization of clinical trials design, and identification of improved treatment and preventive strategies. In this report, the main results of the Task Force discussion are presented.

scholarly journals Assessment in Ankylosing Spondylitis International Working Group/Spondylitis Association of America recommendations for conducting clinical trials in ankylosing spondylitis

2005 ◽  
Vol 52 (2) ◽  
pp. 386-394 ◽  
Author(s):  
D�sir�e van der Heijde ◽  
Maxime Dougados ◽  
John Davis ◽  
Michael H. Weisman ◽  
Walter Maksymowych ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Working Group ◽  
International Working Group

Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8592-8592
Author(s):  
Matthias Weiss ◽  
Morie A. Gertz ◽  
Richard F. Little ◽  
Vincent Rajkumar ◽  
Susanna J. Jacobus ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Phase Ii ◽  
Working Group ◽  
Treatment Options ◽  
Insurance Coverage ◽  
Scientific Progress ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Ct Protocol

8592 Background: Accrual to NCI clinical trials(CT)is often slower than planned at times mandating premature closure resulting in loss of valuable resources and delay of scientific progress. Methods: The NCI-MYSC AWG identified 10 potential BtA. SWOG, ECOG and Alliance investigators were queried and agreed that these barriers impede accrual (results stratified for academic and community sites). The MYSC AWG developed in collaboration with NCI and FDA strategies to overcome these barriers. Results: Strategies listed for the 3 most often cited BtA: 1. Reimbursement for CT related expenses:increase awareness of improved reimbursement for phase II CT; tailor reimbursement according to CT complexity; request funds from industry and other sources ( http://biqsfp.cancer.gov ) for qualifying ancillary CT components. 2. Spectrum of available treatment options influences CT participation: educate patients and providers about the significance of a new CT using social media, presentations at national meetings and by adding educational material to CT protocol; encourage opinion leaders and advocacy groups not to promote a new therapy as “standard” in the absence of phase III data. 3. Requirement of CT specific therapy at NCI designated sites only: “MYSC AWG Drug Administration Table” describes NCI/FDA approved rules for CT specific drug administration; CT protocol will outline which standard treatment components of a CT can be administered at any site as long as protocol specific guidelines are followed and conduct is supervised by enrolling investigator. Examples of additional strategies to overcome identified BtA: determine feasibility, indication and insurance coverage of CT specific tests during protocol development; discourage narrow eligibility criteria; avoid competing CT; allow up to 1 cycle of commercially available therapy prior to enrollment; CIRB support for phase II CT. Conclusions: The MYSC Accrual Working Group developed in collaboration with NCI and FDA strategies to overcome barriers to myeloma clinical trial accrual. These strategies may be applicable to NCI-sponsored clinical trials evaluating interventions in other diseases.

scholarly journals Come in from the Cold: Are Older Adults Who Live in Colder Climates at Greater Risk for Sarcopenia?

2020 ◽  
Vol 9 (6) ◽  
pp. 1859
Author(s):  
David Scott
Keyword(s):  
Older Adults ◽  
Skeletal Muscle ◽  
Older People ◽  
Working Group ◽  
Operational Definition ◽  
Muscle Disease ◽  
European Working Group ◽  
Age Related ◽  
European Working ◽  
Definition Of

The operational definition of “sarcopenia”, an age-related skeletal muscle disease resulting from adverse changes that accrue across the lifetime, was recently updated by the European Working Group on Sarcopenia in Older People (EWGSOP) [...]

scholarly journals THE VICIOUS CYCLE OF MYOSTATIN SIGNALING IN SARCOPENIC OBESITY: MYOSTATIN ROLE IN SKELETAL MUSCLE GROWTH, INSULIN SIGNALING AND IMPLICATIONS FOR CLINICAL TRIALS

2017 ◽  
pp. 1-7
Author(s):  
L.A. CONSITT ◽  
B.C. CLARK
Keyword(s):  
Skeletal Muscle ◽  
Clinical Trials ◽  
Insulin Signaling ◽  
Muscle Growth ◽  
Sarcopenic Obesity ◽  
Health Concern ◽  
Potential Candidate ◽  
Skeletal Muscle Growth ◽  
Age Related

The age-related loss of skeletal muscle (sarcopenia) is a major health concern as it is associated with physical disability, metabolic impairments, and increased mortality. The coexistence of sarcopenia with obesity, termed ‘sarcopenic obesity’, contributes to skeletal muscle insulin resistance and the development of type 2 diabetes, a disease prevalent with advancing age. Despite this knowledge, the mechanisms contributing to sarcopenic obesity remain poorly understood, preventing the development of targeted therapeutics. This article will discuss the clinical and physiological consequences of sarcopenic obesity and propose myostatin as a potential candidate contributing to this condition. A special emphasis will be placed on examining the role of myostatin signaling in impairing both skeletal muscle growth and insulin signaling. In addition, the role of myostatin in regulating muscle-to fat cross talk, further exacerbating metabolic dysfunction in the elderly, will be highlighted. Lastly, we discuss how this knowledge has implications for the design of myostatin-inhibitor clinical trials.

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