Clinical trial NCT01886196: Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
Official title: Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Osteoporosis
Keywords: elderly
women
exercise
pQCT
ibuprofen
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-06-25
Enrollment: 90
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inflammation increases with aging and is implicated in the reduction of bone mass, muscle mass, and strength. Resistance training is safe and effective for increasing muscle mass and strength in older adults,however resistance training by itself cannot suppress inflammation. Ibuprofen is a non-steroidal anti-inflammatory drug that may provide benefits to muscle mass and strength when given after resistance training sessions in older adults; however, more evidence is required to confirm effects across the lifespan. The objectives are to determine the effect of 9 months of exercise training and ibuprofen supplementation, compared to placebo, in older women (≥65years)on the following dependent variables:

* bone density, geometry, and architecture
* muscle mass and strength
* balance

Detailed description: The aim of our study is to create new evidence about the effectiveness and safety of non-steroid anti-inflammatory supplementation (i.e. ibuprofen) combined with exercise to influence positively bone and muscle health in women aged 65 years and older. With aging, there is a significant decrease in bone mineral, muscle mass, and strength, which increases the risk of falls, injuries and fracture especially for women. Direct and indirect health costs associated with osteoporosis and sarcopenia (defined as "muscle wasting") are in the billions of dollars and escalating as the proportion of older adults in Canada grows. Low-grade inflammation is a main contributing factor to bone and muscle deterioration with aging but is mitigated by anti-inflammatory drug use. Recent evidence shows resistance exercise training combined with a non-steroidal anti-inflammatory drug (ibuprofen) is effective for increasing bone mineral density in young women. No study has addressed directly the effects of ibuprofen use following resistance exercise on bone and muscle in older women, the population at greatest risk of developing osteoporosis. The primary purpose of this study is to investigate the safety and multiple effects of ibuprofen ingestion following supervised resistance exercise training on bone and muscle in older women (≥65y).

PRIMARY HYPOTHESES: Ibuprofen combined with resistance training will maintain hip and lumbar spine areal bone mineral density in older women. Secondary hypotheses are that bone structural properties in the hip and wrist, and muscle mass and strength will be improved by supplementing ibuprofen after resistance training sessions.

RESEARCH PLAN: The study will use a repeated measures, parallel group randomized design where 100 women (≥65 y) will be randomized to one of 4 groups: 1) Exercise and ibuprofen (400 mg immediately after exercise); 2) Exercise and ibuprofen placebo; 3) Placebo exercise and ibuprofen, 4) Placebo exercise and ibuprofen placebo. Women will participate in the exercise sessions 3 days per week. The intervention will be 9 months in duration. Dual energy X-ray absorptiometry (DXA) will be used to assess hip and lumbar spine areal bone mineral density, as well as geometric changes in hip structure, and whole body lean tissue (i.e. muscle) mass. Peripheral quantitative computed tomography (pQCT) and high-resolution-pQCT will allow us to investigate detailed changes in bone microarchitecture at the wrist and muscle cross-sectional area in the forearm in response to the intervention. Safety will be addressed by closely monitoring adverse events.

RELEVANCE: This pilot study potentially drives a novel post-market use of ibuprofen. In addition, it permits our developing research team a foray into preliminary data collection to inform a larger randomized controlled trial (RCT) application to CIHR.

Eligibility criteria: Inclusion Criteria:

* women \>65yrs

Exclusion Criteria:

* high risk of fracture
* use of bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, PTH, or calcitonin within the past 12 months
* taking medications that affect bone mineral metabolism
* have diseases that are known to affect bone mineral metabolism
* have severe osteoarthritis
* currently a smoker
* currently participating in moderate-vigorous resistance-exercise training more than once per week

Primary outcomes:
measure: change from baseline in aBMD of the proximal femur and lumbar spine at 9 months
timeFrame: baseline and 9 months
Secondary outcomes:
measure: change from baseline in femoral neck section modulus at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in distal radius Bone Strength Index at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in radial shaft Stress Strain Index at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in radial shaft muscle cross-sectional area at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in total body lean tissue mass at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in muscular strength at 9 months
timeFrame: baseline and 9 months
measure: change from baseline in balance performance at 9 months
timeFrame: baseline and 9 months
Other outcomes:
measure: number of participants with adverse events as a measure of safety and number of participants wit adverse events as a measure of safety and tolerability
timeFrame: continuously throughout 9 months
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip D Chilibeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krentz JR, Quest B, Farthing JP, Quest DW, Chilibeck PD. The effects of ibuprofen on muscle hypertrophy, strength, and soreness during resistance training. Appl Physiol Nutr Metab. 2008 Jun;33(3):470-5. doi: 10.1139/H08-019.