CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01047163
NCT01047163N/ACompleted

Maintenance of Muscle Mass in Older People: the Negative Impact of Statin Therapy

University of Nottingham·observational·Posted Jan 12, 2010·Updated Apr 27, 2016

In Brief

An observational study for Myopathy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

A major contributor to frailty and immobility in the elderly is the age related loss of muscle mass (sarcopenia). Cardiovascular disease (CVD) is the leading cause of mortality in the elderly, with high blood cholesterol and lipids being the major modifiable risk factor. Statins reduce blood cholesterol, but muscle related pain, tenderness and discomfort (myopathy) is an adverse event associated with statin therapy, with older people being at a much greater risk. Statin myopathy presents as muscle aches and weakness, with or without evidence of muscle damage; however the underlying mechanisms responsible for these symptoms are poorly understood. Using an animal model, the applicants have shown the main pathway regulating muscle protein synthesis is inhibited in statin myopathy, and genes regulating muscle protein breakdown, the inhibition of muscle carbohydrate use and inflammation are dramatically increased. Therefore we wish to determine whether these changes are seen in the muscle of older people with symptoms of statin myopathy, and whether this is associated with lower muscle mass and impaired muscle function compared with older people with no history of statin use. Identification of the mechanisms involved in statin myopathy could lead to effective therapy for older people unable to tolerate statins.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMyopathy
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2010
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.5 years ago