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Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Herbert Lindsley, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00682357
First received: May 20, 2008
Last updated: October 5, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Osteoarthritis
Drug: Methylprednisolone and Lidocaine
Drug: Placebo and Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in Serum Osteocalcin [ Time Frame: Change from Baseline Visit to Day 28 ] [ Designated as safety issue: No ]
    Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.

  • Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) [ Time Frame: Change from Baseline Visit to Day 28 ] [ Designated as safety issue: No ]
    Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.


Secondary Outcome Measures:
  • Change in Testosterone [ Time Frame: Change from Baseline Visit to Day 28 ] [ Designated as safety issue: No ]
    Outcome represents the mean change in testosterone level from baseline visit to day 28.

  • Change in Serum Cortisol [ Time Frame: Change from Baseline Visit to Day 28 ] [ Designated as safety issue: No ]
    Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.


Enrollment: 25
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Methylprednisone 80 mg and Lidocaine 20 mg
Drug: Methylprednisolone and Lidocaine
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Experimental: 2
Methylprednisolone 16 mg 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

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
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682357

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Herbert Lindsley, MD
Investigators
Principal Investigator: Herbert Lindsley, MD University of Kansas Medical Center
  More Information

Responsible Party: Herbert Lindsley, MD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00682357     History of Changes
Other Study ID Numbers: 11199 
Study First Received: May 20, 2008
Results First Received: October 5, 2016
Last Updated: October 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
Osteoarthritis, intra articular steroids

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on December 02, 2016