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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

May 20, 2008
September 15, 2008
May 2008
May 2010   (final data collection date for primary outcome measure)
Change in serum markers of bone formation and breakdown [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00682357 on ClinicalTrials.gov Archive Site
  • 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 ]
Change in serum free testosterone [ Time Frame: Visits 1-4 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Osteoarthritis
  • 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
  • Drug: Placebo and Lidocaine
    Placebo and lidocaine 20 mg
  • Experimental: 1
    Methylprednisone 80 mg and Lidocaine 20 mg
    Intervention: Drug: Methylprednisolone and Lidocaine
  • Experimental: 2
    Methylprednisolone 16 mg and Lidocaine 20 mg
    Intervention: Drug: Methylprednisolone and Lidocaine
  • Placebo Comparator: 3
    Placebo and Lidocaine 20 mg
    Intervention: Drug: Placebo and Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
25
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00682357
11199
No
Herbert Lindsley MD, University of Kansas Medical Center
University of Kansas
Not Provided
Principal Investigator: Herbert Lindsley, MD University of Kansas
University of Kansas
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP