The Effects of NSAIDs on Bone Metabolism Following Exercise

  • days left to enroll
  • participants needed
  • sponsor
    United States Army Research Institute of Environmental Medicine
Updated on 4 October 2022
Accepts healthy volunteers


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.

Condition Bone Resorption, Stress Fracture, Bone Injury
Treatment Placebo, Celecoxib 200mg, Ibuprofen 800 mg, Flurbiprofen 100 mg
Clinical Study IdentifierNCT05512013
SponsorUnited States Army Research Institute of Environmental Medicine
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Must currently exercise at least 2 times per week
Must be willing to discontinue the use of nutritional supplements, alcohol and nicotine during each study period (4 trials of 5 consecutive days each), unless approved by PI
Must be willing to refrain from taking NSAIDs and similar medications during the course of the study (other than those given by the study team)
Weigh at least 110 lbs and have a hemoglobin of 12.5 g/dL or higher

Exclusion Criteria

Known allergic reaction to any NSAID type medication
History of gastrointestinal disorders/discomfort associated with or which may be aggravated with NSAID use
History or known gastric ulcer
History of endocrine disorders (e.g., diabetes, uncontrolled thyroid dysfunction, hypoparathyroidism, or hyperparathyroidism)
History of bone-modifying disorder (e.g., osteogenesis imperfecta, osteoporosis, or rickets)
Diagnosed bone fracture within last 6 months
History of cardiovascular or renal diseases
Pregnant or lactation in the last 6 months
Currently taking or history of routine use of medications known to affect bone or calcium metabolism (e.g., thiazide diuretics, bisphosphonates, oral steroids)
History of back or shoulder injury which may be aggravated by exercise
Blood donation within 8 weeks of the study
Current physical illness or injury limiting physical activity
Known allergy to lidocaine
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