Clinical trial NCT00809783: Extension Study Of Tanezumab In Osteoarthritis
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Tanezumab OA arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 2147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Detailed description: This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility criteria: Inclusion Criteria:

* Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

* Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
measure: Number of Participants With Abnormal Laboratory Findings
timeFrame: A4091016: Day 1 up to Week 80
measure: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
timeFrame: A4091016: Baseline (Day 1) up to Week 80
Secondary outcomes:
measure: Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
measure: Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
timeFrame: A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)
measure: Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
timeFrame: Baseline (Day 1) up to Week 80
measure: Number of Participants With Clinically Significant Abnormality in Vital Signs
timeFrame: A4091016: Baseline (Day 1) up to Week 80
measure: Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104
measure: Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104
measure: Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
timeFrame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
measure: Percentage of Participants Who Used Concomitant Analgesic Medication
timeFrame: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
measure: Days Per Week of Concomitant Analgesic Medication Usage
timeFrame: Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
Other outcomes:
measure: Number of Participants Classified According to Number of Intravenous Doses of Study Medication
timeFrame: A4091016: Baseline (Day 1) up to Week 64
Locations:
city: Anniston
country: United States
facility: Pinncale Research Group, LLC
state: Alabama
city: Anniston
country: United States
facility: Anniston Medical Clinic, PC
state: Alabama
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Greystone Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Saadat Ansari, MD Office
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC
state: Arizona
city: Mesa
country: United States
facility: Novara Clinical Research
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Phoenix
country: United States
facility: Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical, Inc.
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph's Mercy Clinic
state: Arkansas
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Englewood
country: United States
facility: Colorado Hematology - Oncology
state: California
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants, PC
state: California
city: Escondido
country: United States
facility: Arthritis Medical Clinic of North County, Inc.
state: California
city: Fountain Valley
country: United States
facility: Edinger Medical Group Clinical Research
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: Lakewood
country: United States
facility: Lakewood Orthopedic Medical & Surgical Group
state: California
city: Lancaster
country: United States
facility: High Desert Medical Group Research for Life
state: California
city: Long Beach
country: United States
facility: Premiere Clinical Research, LLC
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Reseda
country: United States
facility: Del Carmen Medical Center
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research, Corp.
state: California
city: Santa Ana
country: United States
facility: Trinity Clinical Trials
state: California
city: Thousand Oaks
country: United States
facility: Office of Lawrence P McAdam, MD
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Aurora
country: United States
facility: Colorado Orthopedic Consultants, PC
state: Colorado
city: Centennial
country: United States
facility: Peak Anesthesia and Pain Management
state: Colorado
city: Denver
country: United States
facility: Denver Internal Medicine Group
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Denver
country: United States
facility: Advanced Orthopedic and Sports Medicine
state: Colorado
city: Englewood
country: United States
facility: American Clinical Research, LLC
state: Colorado
city: Englewood
country: United States
facility: Orthopaedic Physicians Of Colorado, P.C.
state: Colorado
city: Englewood
country: United States
facility: University Parks Hematology/Oncology
state: Colorado
city: Parker
country: United States
facility: Advanced Orthopedic and Sports Medicine
state: Colorado
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Lewes
country: United States
facility: Delaware Arthritis
state: Delaware
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc.
state: Delaware
city: Bradenton
country: United States
facility: HeartCare (Private Practice)
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: Doral
country: United States
facility: In Vivo Clinical Research, Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: S & W Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Longwood
country: United States
facility: Adult Medicine Specialists
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, Inc
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Incorporated
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Dale G. Bramlet, MD, P.L.
state: Florida
city: Sarasota
country: United States
facility: HeartCare Research
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Atlanta
country: United States
facility: Arthritis and Rheumatology of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc.
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Decatur
country: United States
facility: Jefrey D. Lieberman, MD
state: Georgia
city: Fort Valley
country: United States
facility: Early Family Practice Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Diagnostic Clinic, LLC
state: Georgia
city: Marietta
country: United States
facility: Marietta Rheumatology Associates
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Boise
country: United States
facility: Sonora Clinical Research, LLC.
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute, LLC
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Fishers
country: United States
facility: American Health Network
state: Indiana
city: South Bend
country: United States
facility: Memorial Medical Group Clinical Research Institute
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Lexington
country: United States
facility: Pasadena Pharmacy
state: Kentucky
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: Lexington
country: United States
facility: Arthritis Center of Lexington
state: Kentucky
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc
state: Kentucky
city: Louisville
country: United States
facility: David H. Neustadt, MD
state: Kentucky
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Bone and Joint Clinic of Baton Rouge
state: Louisiana
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: The Baton Rouge Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Stanocola Medical Center
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Centers
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Mansfield
country: United States
facility: Mansfield Health Center
state: Massachusetts
city: Peabody
country: United States
facility: Arthritis Associates Inc.
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: Ann Arbor Clinical Research
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Incorporated
state: Michigan
city: Saint Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center Inc.
state: Minnesota
city: Edina
country: United States
facility: Medical Advanced Pain Specialists
state: Minnesota
city: Port Gibson
country: United States
facility: Planters Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Medex Healthcare Research
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: St. John's Clinic - Neurology
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute, Inc.
state: Missouri
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Henderson
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Independent Clinical Researchers
state: Nevada
city: Las Vegas
country: United States
facility: Wolfson Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Las Vegas
country: United States
facility: Mirkil Medical
state: Nevada
city: Las Vegas
country: United States
facility: G. Timothy Kelly, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of Dr. Danka Michaels, MD
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Incorporated
state: New Mexico
city: Bronx
country: United States
facility: SPRI Bronx LLC
state: New York
city: Brooklyn
country: United States
facility: Arthritis and Osteoporosis Medical Associates
state: New York
city: New York
country: United States
facility: Medex Healthcare Research
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Plainview
country: United States
facility: Prem C. Chatpar, MD, LLC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Roslyn
country: United States
facility: Office of Dr. Andrew Porges
state: New York
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Bone & Joint, PA
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Incorporated
state: Ohio
city: Cincinnati
country: United States
facility: Ohio GI and Liver Institute
state: Ohio
city: Cincinnati
country: United States
facility: Hilltop Medical Research Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: PHP Center for Clinical Research
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting, LLC
state: Ohio
city: Middletown
country: United States
facility: Orthopaedic & Sports Medicine Consultants
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates,Inc
state: Ohio
city: Zanesville
country: United States
facility: Physicians' Research, Inc
state: Ohio
city: Zanesville
country: United States
facility: Primecare of Southeastern Ohio, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Clinton
country: United States
facility: The Family Healthcare Center, PA
state: South Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Rock Hill
country: United States
facility: The Carolina Center for Rheumatology and Arthritis Care, PA
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Johnson City
country: United States
facility: State of Franklin Healthcare Associates, PLLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Capitol Medical Clinic
state: Texas
city: Austin
country: United States
facility: Walter F. Chase, MD, PA
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Dallas
country: United States
facility: North Texas Joint Care, PA
state: Texas
city: Dallas
country: United States
facility: Crown Imaging
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Grapevine
country: United States
facility: O. David Taunton, Jr, MD
state: Texas
city: Houston
country: United States
facility: Asif Cochinwala, MD, PA
state: Texas
city: Houston
country: United States
facility: Foundation for Southwest Orthopedic Research
state: Texas
city: Houston
country: United States
facility: One Step Diagnostic
state: Texas
city: Houston
country: United States
facility: Southwest Orthopedic Group
state: Texas
city: Houston
country: United States
facility: The Neurology Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Lubbock
country: United States
facility: Gill Orthopedic Center
state: Texas
city: Lubbock
country: United States
facility: Robert R. King, M.D.
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Spring
country: United States
facility: Spring Family Practice Associates PA
state: Texas
city: Sugar Land
country: United States
facility: AZ Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Spring Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Sugar Land Med-Ped, P.A.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Incorporated/Foothill Family Clinic South
state: Utah
city: Arlington
country: United States
facility: Commonwealth Orthopaedics and Rehabilitation, PC
state: Virginia
city: Arlington
country: United States
facility: IntegraTrials, LLC
state: Virginia
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Portsmouth
country: United States
facility: Office of Doris M. Rice, MD, FACR
state: Virginia
city: Roanoke
country: United States
facility: HhypotheTest, LLC
state: Virginia
city: Selah
country: United States
facility: Empirical Clinical Trials
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Yakima
country: United States
facility: Clinical Trials Northwest
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.