Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis - Full Text View

Sponsored by:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00682357

Purpose

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.

Condition	Intervention
Osteoarthritis	Drug: Methylprednisolone and Lidocaine Drug: Placebo and Lidocaine

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Methylprednisolone Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Change in serum markers of bone formation and breakdown [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in serum free testosterone (males only) [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]
Changes in serum cortisol [ Time Frame: Visits 1-5 ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Methylprednisone 80 mg and Lidocaine 20 mg	Drug: Methylprednisolone and Lidocaine Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
2: Experimental Methylprednisolone 16 mg and Lidocaine 20 mg	Drug: Methylprednisolone and Lidocaine Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
3: Placebo Comparator Placebo and Lidocaine 20 mg	Drug: Placebo and Lidocaine Placebo and lidocaine 20 mg

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 DEXA bone density status

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682357

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Herbert Lindsley, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Herbert Lindsley MD )
Study ID Numbers:	11199
Study First Received:	May 20, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00682357 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Osteoarthritis, intra articular steroids

Study placed in the following topic categories:

Anti-Inflammatory Agents
Methylprednisolone
Osteoarthritis
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones
Musculoskeletal Diseases
Arthritis
Anti-Arrhythmia Agents

Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Joint Diseases
Lidocaine
Methylprednisolone acetate
Central Nervous System Depressants
Rheumatic Diseases
Cardiovascular Agents
Glucocorticoids
Anesthetics, Local
Prednisolone
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents
Methylprednisolone
Osteoarthritis
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses

Anti-Arrhythmia Agents
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Joint Diseases
Gastrointestinal Agents
Lidocaine
Methylprednisolone acetate
Central Nervous System Depressants
Rheumatic Diseases
Cardiovascular Agents
Glucocorticoids
Protective Agents
Anesthetics, Local
Pharmacologic Actions
Autonomic Agents

ClinicalTrials.gov processed this record on May 07, 2009