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The Effects of NSAIDs on Bone Metabolism Following Exercise

Sponsor
United States Army Research Institute of Environmental Medicine (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05512013
Collaborator
(none)
12
Enrollment
1
Location
4
Arms
13.5
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ibuprofen 800 mg
  • Drug: Celecoxib 200mg
  • Drug: Flurbiprofen 100 mg
  • Drug: Placebo
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
4 trial, block randomized crossover design. Three NSAIDs and one placebo trial.4 trial, block randomized crossover design. Three NSAIDs and one placebo trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Effects of Non-steroidal Anti-inflammatory Drugs on Circulating Markers of Bone Metabolism Following Plyometric Exercise in Humans
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ibuprofen

Participants will consume a single dose of ibuprofen prior to a plyometric exercise bout

Drug: Ibuprofen 800 mg
Ibuprofen taken orally 2 hours prior to exercise
Other Names:
  • Advil
  • Motrin

    		•
    Experimental: Celecoxib

    Participants will consume a single dose of celecoxib prior to a plyometric exercise bout

    Drug: Celecoxib 200mg
    Celebrex taken orally 2 hours prior to exercise
    Other Names:
  • Celebrex

    		•
    Experimental: Flurbiprofen

    Participants will consume a single dose of flurbiprofen prior to a plyometric exercise bout

    Drug: Flurbiprofen 100 mg
    Flurbiprofen taken orally 2 hours prior to exercise
    Other Names:
  • Ansaid

    		•
    Placebo Comparator: Placebo

    Participants will consume a single dose of an inert placebo prior to a plyometric exercise bout

    Drug: Placebo
    Inert placebo taken orally 2 hours prior to exercise

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline circulating marker of bone formation [Change from pre-exercise to 4 hours post-exercise]

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

    Secondary Outcome Measures

    1. Change from baseline circulating marker of bone resorption [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 [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 Outcome Measures

    1. Muscle protein synthesis [Change from pre-exercise to 3 hours post-exercise]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 United States Army Research Institute of Environmental Medicine Natick Massachusetts United States 01760

    Sponsors and Collaborators

    • United States Army Research Institute of Environmental Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Jeffery Staab, Principal Investigator, United States Army Research Institute of Environmental Medicine
    ClinicalTrials.gov Identifier:
    NCT05512013
    Other Study ID Numbers:
    • 21-18H
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Bone Resorption
    Fractures, Stress
    Ibuprofen
    Celecoxib
    Flurbiprofen

    Study Results

    No Results Posted as of Aug 23, 2022