University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT00682357
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.
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Notify Me40 year–85 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Placebo and lidocaine 20 mg
Time frame: Change from Baseline Visit to Day 28
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Time frame: Change from Baseline Visit to Day 28
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
Outcome represents the mean change in testosterone level from baseline visit to day 28.
Time frame: Change from Baseline Visit to Day 28
Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.
University of Kansas Medical Center
Other
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