N/A
N=25
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00682357 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Change in Serum Osteocalcin — -2.18; -0.45; -1.10 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methylprednisolone and Lidocaine (Drug); Placebo and Lidocaine (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Osteocalcin |
-2.18; -0.45; -1.10 | — |
| PRIMARY Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) |
-0.153; -0.295; -0.148 | — |
| SECONDARY Change in Testosterone |
0.08 | — |
| SECONDARY Change in Serum Cortisol |
-1.16; 0.65; 1.30 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age > 40 years
- Male or postmenopausal female
- Diagnosis of knee osteoarthritis
- DEXA bone density done within the past 12 months
- Painful knee, visual analogue scale (VAS) > 4 of (10=worst)
Exclusion Criteria
- Diabetes Mellitus Type I or II
- Systemic inflammatory illness
- Systemic infections which may be aggravated by steroid therapy
- No current or previous (< 3 years) biphosphate therapy
- Previous knee replacement surgery
- No current or previous Parathyroid hormone (PTH) therapy
Data sourced from ClinicalTrials.gov (NCT00682357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.