Study of Recombinant Human Bone Morphogenetic Protein in Subjects with Decreased Bone Mineral Density

Osteoporosis is a bone disease characterized by decreased bone density and the breakdown of bone tissue. It can lead to weakened bones, placing the person at increased risk for bone fractures, usually of the hip, wrist, or spine. This study is an osteoporosis clinical research study to test whether an investigational drug, given by injection, safely increases the bone mass of the hip when given in addition to regular osteoporosis therapy. This research study will enroll women who are at increased risk of having a hip fracture as indicated by low bone density.

During the 3 years of participation, all volunteers will receive the usual (standard) treatment for low bone mass; bisphosphonate medication with calcium and vitamin D supplementation. In addition to the usual treatment, some people will receive a one-time injection of the investigational drug in one of their hips. This injection is given in a surgery room using a light anesthesia to numb the hip area and help with relaxation. Participants can expect a total of 10 visits to the study doctor for medical evaluations, which include regular bone density tests.