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The Effects of NSAIDs on Bone Metabolism Following Exercise

NCT ID: NCT05512013

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-04-01

Brief Summary

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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

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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

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Bone Resorption Stress Fracture Bone Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

4 trial, block randomized crossover design. Three NSAIDs and one placebo trial.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ibuprofen

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

Group Type EXPERIMENTAL

Ibuprofen 800 mg

Intervention Type DRUG

Ibuprofen taken orally 2 hours prior to exercise

Celecoxib

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

Group Type EXPERIMENTAL

Celecoxib 200mg

Intervention Type DRUG

Celebrex taken orally 2 hours prior to exercise

Flurbiprofen

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

Group Type EXPERIMENTAL

Flurbiprofen 100 mg

Intervention Type DRUG

Flurbiprofen taken orally 2 hours prior to exercise

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inert placebo taken orally 2 hours prior to exercise

Interventions

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Ibuprofen 800 mg

Ibuprofen taken orally 2 hours prior to exercise

Intervention Type DRUG

Celecoxib 200mg

Celebrex taken orally 2 hours prior to exercise

Intervention Type DRUG

Flurbiprofen 100 mg

Flurbiprofen taken orally 2 hours prior to exercise

Intervention Type DRUG

Placebo

Inert placebo taken orally 2 hours prior to exercise

Intervention Type DRUG

Other Intervention Names

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Advil Motrin Celebrex Ansaid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Jeffery Staab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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United States Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Site Status

Countries

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United States

References

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Staab JS, Kolb AL, Tomlinson RE, Pajevic PD, Matheny RW Jr, Hughes JM. Emerging evidence that adaptive bone formation inhibition by non-steroidal anti-inflammatory drugs increases stress fracture risk. Exp Biol Med (Maywood). 2021 May;246(9):1104-1111. doi: 10.1177/1535370221993098. Epub 2021 Feb 27.

Reference Type BACKGROUND
PMID: 33641442 (View on PubMed)

Jankowski CM, Shea K, Barry DW, Linnebur SA, Wolfe P, Kittelson J, Schwartz RS, Kohrt WM. Timing of Ibuprofen Use and Musculoskeletal Adaptations to Exercise Training in Older Adults. Bone Rep. 2015 Jan 1;1:1-8. doi: 10.1016/j.bonr.2014.10.003.

Reference Type BACKGROUND
PMID: 25642444 (View on PubMed)

Kohrt WM, Barry DW, Van Pelt RE, Jankowski CM, Wolfe P, Schwartz RS. Timing of ibuprofen use and bone mineral density adaptations to exercise training. J Bone Miner Res. 2010 Jun;25(6):1415-22. doi: 10.1002/jbmr.24.

Reference Type BACKGROUND
PMID: 20200939 (View on PubMed)

Wherry SJ, Wolfe P, Schwartz RS, Kohrt WM, Jankowski CM. Ibuprofen taken before exercise blunts the IL-6 response in older adults but does not alter bone alkaline phosphatase or c-telopeptide. Eur J Appl Physiol. 2021 Aug;121(8):2187-2192. doi: 10.1007/s00421-021-04691-8. Epub 2021 Apr 19.

Reference Type BACKGROUND
PMID: 33876259 (View on PubMed)

Brewer CB, Bentley JP, Day LB, Waddell DE. Resistance exercise and naproxen sodium: effects on a stable PGF2alpha metabolite and morphological adaptations of the upper body appendicular skeleton. Inflammopharmacology. 2015 Dec;23(6):319-27. doi: 10.1007/s10787-015-0248-x. Epub 2015 Aug 20.

Reference Type BACKGROUND
PMID: 26289996 (View on PubMed)

Park J, Fertala A, Tomlinson RE. Naproxen impairs load-induced bone formation, reduces bone toughness, and diminishes woven bone formation following stress fracture in mice. Bone. 2019 Jul;124:22-32. doi: 10.1016/j.bone.2019.04.009. Epub 2019 Apr 15.

Reference Type BACKGROUND
PMID: 30998998 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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21-18H

Identifier Type: -

Identifier Source: org_study_id