Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone and Lidocaine
Methylprednisolone and Lidocaine
Placebo and Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis focused on measuring Osteoarthritis, intra articular steroids
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Methylprednisone 80 mg and Lidocaine 20 mg
Methylprednisolone 16 mg and Lidocaine 20 mg
Placebo and Lidocaine 20 mg
Outcomes
Primary Outcome Measures
Change in Serum Osteocalcin
Change in serum markers of bone formation (osteocalcin) from Day 0 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.
Secondary Outcome Measures
Change in Testosterone
Outcome represents the mean change in testosterone level 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00682357
Brief Title
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
Official Title
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Herbert Lindsley, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, intra articular steroids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Methylprednisone 80 mg and Lidocaine 20 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Methylprednisolone 16 mg and Lidocaine 20 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo and Lidocaine 20 mg
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone and Lidocaine
Intervention Description
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone and Lidocaine
Intervention Description
Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
Intervention Type
Drug
Intervention Name(s)
Placebo and Lidocaine
Intervention Description
Placebo and lidocaine 20 mg
Primary Outcome Measure Information:
Title
Change in Serum Osteocalcin
Description
Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.
Time Frame
Change from Baseline Visit to Day 28
Title
Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
Description
Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.
Time Frame
Change from Baseline Visit to Day 28
Secondary Outcome Measure Information:
Title
Change in Testosterone
Description
Outcome represents the mean change in testosterone level from baseline visit to day 28.
Time Frame
Change from Baseline Visit to Day 28
Title
Change in Serum Cortisol
Description
Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.
Time Frame
Change from Baseline Visit to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Lindsley, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
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