Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Methylprednisolone and Lidocaine; Drug: Methylprednisolone and Lidocaine; Drug: Placebo and Lidocaine

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Methylprednisone 80 mg and Lidocaine 20 mg	Drug: Methylprednisolone and Lidocaine; Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg; Drug: Methylprednisolone and Lidocaine; Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
EXPERIMENTAL: 2; Methylprednisolone 16 mg and Lidocaine 20 mg	Drug: Methylprednisolone and Lidocaine; Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg; Drug: Methylprednisolone and Lidocaine; Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
PLACEBO_COMPARATOR: 3; Placebo and Lidocaine 20 mg	Drug: Placebo and Lidocaine; Placebo and lidocaine 20 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herbert Lindsley, MD

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: May 21, 2008
• First Posted (ESTIMATE): May 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 29, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis, intra articular steroids
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: 11199 (REGISTRY: DAIDS ES Registry Number)