The Effects of Celecoxib on Bone Ingrowth

This study has been terminated.

( New clinical finding with Celebrex and cardiac concerns. )

First Received: December 26, 2007 Last Updated: September 30, 2008 History of Changes

Sponsor:	University of Utah
Collaborator:	Pfizer
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00585156

Purpose

The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.

Condition	Intervention	Phase
Bone Ingrowth Pain	Drug: Celecoxib	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study
Official Title:	The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Bone Ingrowth [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain Score [ Time Frame: 10 days postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment:	9
Study Start Date:	June 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm #1: Experimental Celebrex treatment group	Drug: Celecoxib Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

Exclusion Criteria:

Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
Patients who have had CABG.
Patients with a history of peptic ulcer disease, duodenal ulcers.
Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585156

Locations

United States, Utah
Veteran Affairs (VA) Medical Center
Salt Lake City, Utah, United States, 84148

Sponsors and Collaborators

University of Utah

Pfizer

Investigators

Principal Investigator:

Roy Bloebaum, Ph.D.

Research Professor, Orthopedic Surgery

More Information

Publications:

Hofmann AA, Bloebaum RD, Rubman MH, Bachus KN, Plaster RL. Microscopic analysis of autograft bone applied at the interface of porous-coated devices in human cancellous bone. Int Orthop. 1992;16(4):349-58.

Hofmann AA, Bloebaum RD, Koller KE, Lahav A. Does celecoxib have an adverse effect on bone remodeling and ingrowth in humans? Clin Orthop Relat Res. 2006 Nov;452:200-4.

Responsible Party:	University of Utah Department of Orthopedics ( Roy D. Bloebaum, Ph.D. )
Study ID Numbers:	IIR#2005-0300, IIR#2005-0300
Study First Received:	December 26, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00585156 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Utah:

Celebrex, Bone Ingrowth, Pain relief

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010