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Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00682357
First received: May 20, 2008
Last updated: September 15, 2008
Last verified: September 2008
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in serum markers of bone formation and breakdown [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum free testosterone (males only) [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]
  • Changes in serum cortisol [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (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 DEXA bone density status

  Eligibility

Ages Eligible for Study:   40 Years and older
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, 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 PTH therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682357

Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Herbert Lindsley, MD University of Kansas
  More Information

No publications provided

Responsible Party: Herbert Lindsley MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00682357     History of Changes
Other Study ID Numbers: 11199
Study First Received: May 20, 2008
Last Updated: September 15, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013