Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Methylprednisolone and Lidocaine
* Drug: Methylprednisolone and Lidocaine
* Drug: Placebo and Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Methylprednisone 80 mg and Lidocaine 20 mg | Drug: Methylprednisolone and Lidocaine<br>* Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg<br>|
| Experimental: 2<br>Methylprednisolone 16 mg and Lidocaine 20 mg | Drug: Methylprednisolone and Lidocaine<br>* Methylprednisolone 16 mg intra-articular and lidocaine 20 mg<br>|
| Placebo Comparator: 3<br>Placebo and Lidocaine 20 mg | Drug: Placebo and Lidocaine<br>* Placebo and lidocaine 20 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Osteocalcin | Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. | 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. | Change from Baseline Visit to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Testosterone | Outcome represents the mean change in testosterone level from baseline visit to day 28. | 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. | Change from Baseline Visit to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, intra articular steroids