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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
Herbert Lindsley, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Osteoarthritis, intra articular steroids

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 20, 2008
Last Updated
October 5, 2016
Sponsor
Herbert Lindsley, MD
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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

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Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

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