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