The Effects of NSAIDs on Bone Metabolism Following Exercise

United States Army Research Institute of Environmental Medicine

Status and phase: Completed; Phase 1

Conditions: Stress Fracture; Bone Injury; Bone Resorption

Treatments: Drug: Ibuprofen 800 mg; Drug: Celecoxib 200mg; Drug: Flurbiprofen 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05512013

21-18H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 4 patient groups, including a placebo group

Ibuprofen

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen 800 mg

Celecoxib

Experimental group

Description:

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

Treatment:

Drug: Celecoxib 200mg

Flurbiprofen

Experimental group

Description:

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

Treatment:

Drug: Flurbiprofen 100 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo