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



Status:Completed
Conditions:Osteoporosis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:65 - 85
Updated:10/14/2017
Start Date:December 2008
End Date:April 2015

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
29
sites
Sacramento, California 95814
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
?
mi
from
Altoona, PA
Click here to add this to my saved trials
Deland, Florida 32720
?
mi
from
Deland, FL
Click here to add this to my saved trials
Deland, Florida 32720
?
mi
from
Deland, FL
Click here to add this to my saved trials
Deland, Florida 32720
?
mi
from
Deland, FL
Click here to add this to my saved trials
151 Victoria Commons Boulevard
Deland, Florida 32724
?
mi
from
Deland, FL
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Franklin, Tennessee 37067
?
mi
from
Franklin, TN
Click here to add this to my saved trials
Ft. Lauderdale, Florida 33311
?
mi
from
Ft. Lauderdale, FL
Click here to add this to my saved trials
Ft. Lauderdale, Florida 33316
?
mi
from
Ft. Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Gent,
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Port Richey, Florida 34653
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Phoenix, Arizona 85023
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Port Richey, Florida 34668
?
mi
from
Port Richey, FL
Click here to add this to my saved trials
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Louis, Missouri 63108
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
State College, Pennsylvania 16801
?
mi
from
State College, PA
Click here to add this to my saved trials
Trinity, Florida 34655
?
mi
from
Trinity, FL
Click here to add this to my saved trials
Tucson, Arizona 85713
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Watertown, South Dakota 57201
?
mi
from
Watertown, SD
Click here to add this to my saved trials
401 9th Avenue Northwest
Watertown, South Dakota 57201
?
mi
from
Watertown, SD
Click here to add this to my saved trials