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

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

sites

Cool Spring Interventional, PLLC

Franklin, Tennessee 37067

from

Franklin, TN