Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00682357
• Other study ID #: 11199
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 20, 2008
• Last updated: September 15, 2008
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: September 2008
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Methylprednisolone and Lidocaine
Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
• Methylprednisolone and Lidocaine
Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
• Placebo and Lidocaine
Placebo and lidocaine 20 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum markers of bone formation and breakdown		Visits 1-5	No
Secondary	Change in serum free testosterone (males only)		Visits 1-5	No
Secondary	Changes in serum cortisol		Visits 1-5	No