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Completed

NCT Number: NCT05512013

The Effects of NSAIDs on Bone Metabolism Following Exercise

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.

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Key information

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

United States Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 800 mg

Drug

Ibuprofen taken orally 2 hours prior to exercise

Other names: Advil, Motrin

Celecoxib 200mg

Drug

Celebrex taken orally 2 hours prior to exercise

Other names: Celebrex

Flurbiprofen 100 mg

Drug

Flurbiprofen taken orally 2 hours prior to exercise

Other names: Ansaid

Placebo

Drug

Inert placebo taken orally 2 hours prior to exercise

Primary outcomes

  1. Change from baseline circulating marker of bone formation

    Time frame: Change from pre-exercise to 4 hours post-exercise

    Concentration (pg/mL) of serum N-terminal propeptide of type 1 collagen (P1NP)

Secondary outcomes

  1. Change from baseline circulating marker of bone resorption

    Time frame: Change from pre-exercise to 4 hours post-exercise

    Concentration (pg/mL) of serum C-terminal propeptide of type I collagen (CTX)

  2. Markers of muscle inflammation

    Time frame: Change from pre-exercise to 3 hours post-exercise

    Interlukin-6 (IL-6), Interlukin-10 (IL-10), and tissue necrosis factor (TNF-a) messenger ribonucleic acid (mRNA) concentration in muscle biopsy tissue

Other outcomes

  1. Muscle protein synthesis

    Time frame: Change from pre-exercise to 3 hours post-exercise

    ribosomal protein S6 (p-RPS6) protein concentration in muscle biopsy tissue

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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