Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 3, 2008

Primary Completion Date

April 24, 2015

Study Completion Date

April 24, 2015

Conditions
Osteoporosis
Interventions
DRUG

rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)

Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.

DRUG

rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)

Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.

DRUG

bisphosphonates, calcium, and vitamin D

Oral bisphosphonate therapy

Trial Locations (35)

3600

Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont, Waterschei (Genk)

9000

Universitair Ziekenhuis Gent, Ghent

10032

Columbia University Medical Center, New York

16602

University Orthopedics Center, Altoona

16801

University Orthopedics Center, State College

27710

Duke University Medical Center, Durham

28006

Clinica Ruber, Madrid

28009

Instituto Palacios de Salud y Medicina de la Mujer, Madrid

32720

Florida Hospital Deland, DeLand

Florida Orthopaedic Associates, P.A., DeLand

Florida Research Associates, LLC, DeLand

32724

Victoria Park Imaging, DeLand

33311

Diagnostic Professionals, Inc., Fort Lauderdale

33316

Shrock Orthopedic Research, Fort Lauderdale

33324

Westside Regional Medical Center, Plantation

34652

Suncoast Clinical Research Inc, New Port Richey

34653

Coastal orthopedic and Sports Medicine, New Port Richey

34655

Medical Center of Trinity, Trinity

34668

Florida Arthritis & Osteoporosis Center, Port Richey

37067

Cool Spring Interventional, PLLC, Franklin

57201

Brown Clinic, Watertown

63110

Intensive Research Unit, St Louis

Washington University School of Medicine, St Louis

63310

Center for Advanced Medicine, St Louis

68131

Creighton University Medical Center, Omaha

Creighton University Osteoporosis Research Center, Omaha

85023

Arizona Research Center, Inc., Phoenix

85027

John C. Lincoln Hospital - Deer Valley, Phoenix

85712

Tucson Orthopaedic Institute, Tucson

95817

UC Davis Medical Center, Sacramento

57201G

Prairie Lakes Healthcare Systems, Watertown

37208-3599

Center for Women's Health Research at Meharry Medical College, Nashville

01-192

Synexus Polska Sp. z o.o., Warsaw

01-258

Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej, Warsaw

02-507

Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY