Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Methylprednisolone and Lidocaine; Drug: Placebo and Lidocaine

• Registration Number: NCT00682357
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2009-11
• Study Completion: 2010-05
• Results First Submitted: 2016-10-05
• Results First Submitted QC: 2016-10-05
• Results First Posted: 2016-11-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methylprednisolone and Lidocaine	Methylprednisone 80 mg and Lidocaine 20 mg
2	Methylprednisolone and Lidocaine	Methylprednisolone 16 mg and Lidocaine 20 mg
3	Placebo and Lidocaine	Placebo and Lidocaine 20 mg

Primary Outcome Measures

Name	Time	Method
Change in Serum Osteocalcin	Change from Baseline Visit to Day 28	Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Testosterone	Change from Baseline Visit to Day 28	Outcome represents the mean change in testosterone level from baseline visit to day 28.
Change in Serum Cortisol	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States