Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women

Osteoporosis Clinical Trial

Official title:

Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886196
• Other study ID #: 12-256
• Secondary ID: DC0190GP
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: May 2, 2017
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2017
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia

Intervention

Drug:
• Non-steroidal anti-inflammatory drug (Ibuprofen)
400mg of ibuprofen administered after exercise training session 3 days per week

Other:
• placebo
placebo designed to mimic experimental drug (ibuprofen)

Behavioral:
• Resistance exercise
3 sets of 8-12 repetitions of resistance exercise (full body with a focus on the distal radius) completed 3 days/week under supervision in the research gym
• Flexibility training
3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised

Locations

Country	Name	City	State
Canada	College of Kinesiology	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	adverse events as reported by participants and charted on 'adverse events' form	continuously throughout 9 months
Primary	change from baseline in aBMD of the proximal femur and lumbar spine at 9 months	areal bone mineral density of the proximal femure and lumbar spine assessed by dual energy x-ray absorptiometry	baseline and 9 months
Secondary	change from baseline in femoral neck section modulus at 9 months	femoral neck section modulus assessed by dual energy x-ray absorptiometry	baseline and 9 months
Secondary	change from baseline in distal radius Bone Strength Index at 9 months	distal radius Bone Strength Index assessed by high resolution peripheral quantitative computed tomography	baseline and 9 months
Secondary	change from baseline in radial shaft Stress Strain Index at 9 months	radial shaft Stress Strain Index assessed by peripheral quantitative computed tomography	baseline and 9 months
Secondary	change from baseline in radial shaft muscle cross-sectional area at 9 months	radial shaft muscle cross-sectional area assessed by peripheral quantitative computed tomography	baseline and 9 months
Secondary	change from baseline in total body lean tissue mass at 9 months	total body lean tissue mass assessed by dual energy x-ray absorptiometry	baseline and 9 months
Secondary	change from baseline in muscular strength at 9 months	muscular strength assessed by 1 repetition maximum bicep curl and leg press	baseline and 9 months
Secondary	change from baseline in balance performance at 9 months	balance performance assessed by tandem walk on balance board	baseline and 9 months