Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

University of Kansas

Status: Completed

Conditions: Osteoarthritis

Treatments: Drug: Placebo and Lidocaine; Drug: Methylprednisolone and Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00682357

11199 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Methylprednisone 80 mg and Lidocaine 20 mg

Treatment:

Drug: Methylprednisolone and Lidocaine

Drug: Methylprednisolone and Lidocaine

2

Experimental group

Description:

Methylprednisolone 16 mg and Lidocaine 20 mg

Treatment:

Drug: Methylprednisolone and Lidocaine

Drug: Methylprednisolone and Lidocaine

3

Placebo Comparator group

Description:

Placebo and Lidocaine 20 mg

Treatment:

Drug: Placebo and Lidocaine