A Phase 1 interventional study of Ibuprofen 800 mg and Celecoxib 200mg in Bone Resorption, Stress Fracture and Bone Injury, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by United States Army Research Institute of Environmental Medicine · Phase 1, Interventional, and Basic science
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.
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.
153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.
This study's enrollment of 12 is below the median of 22 across 133 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants will consume a single dose of ibuprofen prior to a plyometric exercise bout
Drug: Ibuprofen 800 mg
Participants will consume a single dose of celecoxib prior to a plyometric exercise bout
Drug: Celecoxib 200mg
Participants will consume a single dose of flurbiprofen prior to a plyometric exercise bout
Drug: Flurbiprofen 100 mg
Participants will consume a single dose of an inert placebo prior to a plyometric exercise bout
Drug: Placebo
Ibuprofen taken orally 2 hours prior to exercise
Also known as: Advil, Motrin
Celebrex taken orally 2 hours prior to exercise
Also known as: Celebrex
Flurbiprofen taken orally 2 hours prior to exercise
Also known as: Ansaid
Inert placebo taken orally 2 hours prior to exercise
Change from baseline circulating marker of bone formation
Concentration (pg/mL) of serum N-terminal propeptide of type 1 collagen (P1NP)
Time frame: Change from pre-exercise to 4 hours post-exercise
Change from baseline circulating marker of bone resorption
Concentration (pg/mL) of serum C-terminal propeptide of type I collagen (CTX)
Time frame: Change from pre-exercise to 4 hours post-exercise
Markers of muscle inflammation
Interlukin-6 (IL-6), Interlukin-10 (IL-10), and tissue necrosis factor (TNF-a) messenger ribonucleic acid (mRNA) concentration in muscle biopsy tissue
Time frame: Change from pre-exercise to 3 hours post-exercise
Muscle protein synthesis
ribosomal protein S6 (p-RPS6) protein concentration in muscle biopsy tissue
Time frame: Change from pre-exercise to 3 hours post-exercise
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Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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United States Army Research Institute of Environmental Medicine