Clinical trial NCT00752557: Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Official title: A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Bone mineral density
bone morphogenetic protein
osteoporosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
* 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:

* Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency \[ less than 20 ng/mL\], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
* 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.

Primary outcomes:
measure: Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
timeFrame: Baseline, 12 months post dose
measure: Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
timeFrame: At Month 12
measure: Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
timeFrame: At Month 12
Secondary outcomes:
measure: Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
timeFrame: 24 months
measure: Number Participant Responses to Injectability Questionnaire Injected Population
timeFrame: Participants were monitored after treatment administration (dosing period)
measure: Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
timeFrame: Baseline up to 12 months
measure: Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
timeFrame: 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Phoenix
country: United States
facility: John C. Lincoln Hospital - Deer Valley
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: DeLand
country: United States
facility: Florida Hospital Deland
state: Florida
city: DeLand
country: United States
facility: Florida Orthopaedic Associates, P.A.
state: Florida
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: DeLand
country: United States
facility: Victoria Park Imaging
state: Florida
city: Fort Lauderdale
country: United States
facility: Diagnostic Professionals, Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Inc
state: Florida
city: New Port Richey
country: United States
facility: Coastal orthopedic and Sports Medicine
state: Florida
city: Plantation
country: United States
facility: Westside Regional Medical Center
state: Florida
city: Port Richey
country: United States
facility: Florida Arthritis & Osteoporosis Center
state: Florida
city: Trinity
country: United States
facility: Medical Center of Trinity
state: Florida
city: Saint Louis
country: United States
facility: Intensive Research Unit
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Osteoporosis Research Center
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Watertown
country: United States
facility: Prairie Lakes Healthcare Systems
state: South Dakota
city: Watertown
country: United States
facility: Brown Clinic
state: South Dakota
city: Franklin
country: United States
facility: Cool Spring Interventional, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Center for Women's Health Research at Meharry Medical College
state: Tennessee
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Waterschei (Genk)
country: Belgium
facility: Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
city: Warsaw
country: Poland
facility: Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
state: Mazowieckie
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
state: Mazowieckie
city: Madrid
country: Spain
facility: Clinica Ruber
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: