Overview

The Effects of NSAIDs on Bone Metabolism Following Exercise

Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Treatments:
Celecoxib
Flurbiprofen
Ibuprofen
Criteria
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