Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.
Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
Placebo and lidocaine 20 mg
University of Kansas Medical Center
Kansas City, Kansas, United States
Change in Serum Osteocalcin
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Time frame: Change from Baseline Visit to Day 28
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.
Time frame: Change from Baseline Visit to Day 28
Change in Testosterone
Outcome represents the mean change in testosterone level from baseline visit to day 28.
Time frame: Change from Baseline Visit to Day 28
Change in Serum Cortisol
Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.
Time frame: Change from Baseline Visit to Day 28
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