Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

NCT00682357 | Completed Results

• 1 other identifier: 11199
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis, intra articular steroids

Outcome Measures

Primary Outcomes (2)

• Change in Serum Osteocalcin

  Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.

  Change from Baseline Visit 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.

  Change from Baseline Visit to Day 28

Secondary Outcomes (2)

• Change in Testosterone

  Change from Baseline Visit to Day 28

• Change in Serum Cortisol

  Change from Baseline Visit to Day 28

Study Arms (3)

1

EXPERIMENTAL

Methylprednisone 80 mg and Lidocaine 20 mg

Drug: Methylprednisolone and Lidocaine

2

EXPERIMENTAL

Methylprednisolone 16 mg and Lidocaine 20 mg

Drug: Methylprednisolone and Lidocaine

3

PLACEBO COMPARATOR

Placebo and Lidocaine 20 mg

Drug: Placebo and Lidocaine

Interventions

Methylprednisolone and Lidocaine DRUG

Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg

1

Placebo and Lidocaine DRUG

Placebo and lidocaine 20 mg

3

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Methylprednisolone; Lidocaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Herbert Lindsley
• Organization: University of Kansas Medical Center

HLINDSLE@kumc.edu

(913) 588-3402

Study Officials

• Herbert Lindsley, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2010
• Last Updated: August 13, 2024
• Results First Posted: November 29, 2016

Record last verified: 2024-08

Locations

US (1)