CINCINNATI—Osteoporosis experts at the University of Cincinnati (UC) are participating in a phase-2, international trial of a drug that may stimulate bone growth and slow bone loss.
Led locally by Nelson Watts, MD, director of UC’s Bone Health and Osteoporosis Center, researchers need postmenopausal women aged 45–85 with osteoporosis to participate in the national study. Women with osteoporosis who are not currently being treated with medication may be eligible to participate. Also, women who are interested in the study but have not been diagnosed with osteoporosis, which is done through bone density testing, may be eligible for testing at no charge to determine eligibility.
Bone is a complex living tissue that constantly renews itself. With aging, however, bone breaks down faster than new bone is formed (osteoporosis).
Medications currently on the market to treat osteoporosis generally work in one of two ways—they stimulate the cells (osteoblasts) that form new bone, or they work to slow down the cells (osteoclasts) that break down bone.
“While there are good medications available to treat osteoporosis, unfortunately there isn’t a drug that effectively works to both stimulate bone formation and slow down the bone removal process,” says Watts.
“There are drugs that work on both sides of bone remodeling (removal and formation), but they generally impact one more than the other.”
For example, Watts says that while some drugs currently used to treat the disease stimulate bone formation, they also stimulate the cells that remove bone. Because of this, it is recommended these medications only be taken for up to two years.
In preclinical and phase-1 trials, the trial drug, known as BA058, appeared to induce bone formation without causing bone resorption (removal) or hypercalcemia (elevated calcium in the blood).
BA058 is a code name for a chemically synthesized version of a parathyroid hormone–related protein (PTHrP), a naturally-occurring hormone produced by bone cells and responsible for the local stimulation of bone growth throughout life.
Study participants will receive BA058 daily for 12 weeks. Three groups will receive different doses of BA058, one group will receive a placebo, and a fifth group will receive teriparatide, a drug approved by the Food and Drug Administration for treatment of osteoporosis.
The study is sponsored by Radius Health Inc. Watts has no financial interest in the company.
For more information on trial eligibility, contact Cindy Powell at (513) 475-7415.