NCT05512013

The Effects of NSAIDs on Bone Metabolism Following Exercise

The Effects of Non-steroidal Anti-inflammatory Drugs on Circulating Markers of Bone Metabolism Following Plyometric Exercise in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: United States Army Research Institute of Environmental Medicine · Federal
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effects of a single dose of non-steroidal anti-inflammatory drugs on post-exercise markers of bone and muscle metabolism.

Detailed description

This protocol intends to determine how consuming a single dose of a non-steroidal anti-inflammatory drug (NSAID) affects circulating bone metabolism biomarkers and markers of damage skeletal muscle in response to a bout of plyometric exercise. This will be accomplished using a four trial, placebo-controlled crossover design with trials examining ibuprofen, celecoxib, flurbiprofen and placebo. These particular NSAIDs were chosen because of their widespread use in military populations and differing molecular mechanisms, which could cause differing effects on bone and muscle. Two hours after of consuming a single dose of an NSAID, participants will perform 10 sets of 10 plyometric jumps to induce a mechanical loading stimulus the bone and muscle tissues. Blood, urine, and muscle biopsy samples will be collected before and up to four hours after exercise. Biomarkers representing bone and muscle metabolism will determine the magnitude of adaptive responses to plyometric exercise while using NSAIDs.

Conditions

• Bone Resorption
• Stress Fracture
• Bone Injury

Interventions

Type	Name	Description
DRUG	Ibuprofen 800 mg	Ibuprofen taken orally 2 hours prior to exercise
DRUG	Celecoxib 200mg	Celebrex taken orally 2 hours prior to exercise
DRUG	Flurbiprofen 100 mg	Flurbiprofen taken orally 2 hours prior to exercise
DRUG	Placebo	Inert placebo taken orally 2 hours prior to exercise

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2022-08-23
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study