Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
NCT ID: NCT00752557
Last Updated: 2020-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2008-12-03
2015-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
rhBMP-2/CPM , 1.0 mg/mL
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.
2
rhBMP-2/CPM , 2.0 mg/mL
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.
3
Oral bisphosphonate therapy (standard of care)
bisphosphonates, calcium, and vitamin D
Oral bisphosphonate therapy
Interventions
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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.
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.
bisphosphonates, calcium, and vitamin D
Oral bisphosphonate therapy
Eligibility Criteria
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Inclusion Criteria
* BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
* Age greater than 75 years
* Family (maternal) history of fragility fracture
* Previous fragility fracture (self) after age 45
* Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Exclusion Criteria
* Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
* Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
65 Years
85 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arizona Research Center, Inc.
Phoenix, Arizona, United States
John C. Lincoln Hospital - Deer Valley
Phoenix, Arizona, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
UC Davis Medical Center
Sacramento, California, United States
Florida Hospital Deland
DeLand, Florida, United States
Florida Orthopaedic Associates, P.A.
DeLand, Florida, United States
Florida Research Associates, LLC
DeLand, Florida, United States
Victoria Park Imaging
DeLand, Florida, United States
Diagnostic Professionals, Inc.
Fort Lauderdale, Florida, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
Suncoast Clinical Research Inc
New Port Richey, Florida, United States
Coastal orthopedic and Sports Medicine
New Port Richey, Florida, United States
Westside Regional Medical Center
Plantation, Florida, United States
Florida Arthritis & Osteoporosis Center
Port Richey, Florida, United States
Medical Center of Trinity
Trinity, Florida, United States
Intensive Research Unit
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Center for Advanced Medicine
St Louis, Missouri, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Creighton University Osteoporosis Research Center
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
University Orthopedics Center
State College, Pennsylvania, United States
Prairie Lakes Healthcare Systems
Watertown, South Dakota, United States
Brown Clinic
Watertown, South Dakota, United States
Cool Spring Interventional, PLLC
Franklin, Tennessee, United States
Center for Women's Health Research at Meharry Medical College
Nashville, Tennessee, United States
Universitair Ziekenhuis Gent
Ghent, , Belgium
Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
Waterschei (Genk), , Belgium
Synexus Polska Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
Warsaw, Masovian Voivodeship, Poland
Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
Warsaw, Masovian Voivodeship, Poland
Clinica Ruber
Madrid, , Spain
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1921002
Identifier Type: OTHER
Identifier Source: secondary_id
2007-007456-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3100N0-2213
Identifier Type: -
Identifier Source: org_study_id
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