Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

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.

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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

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Methylprednisone 80 mg and Lidocaine 20 mg

Group Type EXPERIMENTAL

Methylprednisolone and Lidocaine

Intervention Type DRUG

Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg

2

Methylprednisolone 16 mg and Lidocaine 20 mg

Group Type EXPERIMENTAL

Methylprednisolone and Lidocaine

Intervention Type DRUG

Methylprednisolone 16 mg intra-articular and lidocaine 20 mg

3

Placebo and Lidocaine 20 mg

Group Type PLACEBO_COMPARATOR

Placebo and Lidocaine

Intervention Type DRUG

Placebo and lidocaine 20 mg

Interventions

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Methylprednisolone and Lidocaine

Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg

Intervention Type DRUG

Methylprednisolone and Lidocaine

Methylprednisolone 16 mg intra-articular and lidocaine 20 mg

Intervention Type DRUG

Placebo and Lidocaine

Placebo and lidocaine 20 mg

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No