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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

May 20, 2008
October 5, 2016
May 2008
November 2009   (final data collection date for primary outcome measure)
  • 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.
Change in serum markers of bone formation and breakdown [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00682357 on ClinicalTrials.gov Archive Site
  • 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.
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 Dual-energy X-ray absorptiometry (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.
 
Completed
25
May 2010
November 2009   (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, 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
Both
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00682357
11199
No
Not Provided
Not Provided
Herbert Lindsley, MD, University of Kansas Medical Center
Herbert Lindsley, MD
Not Provided
Principal Investigator: Herbert Lindsley, MD University of Kansas Medical Center
University of Kansas Medical Center
October 2016

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