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University of Pittsburgh trial will investigate new osteoporosis drug
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Endocrinologists at the University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center are starting a human trial comparing the only FDA-approved anabolic agent with a new osteoporosis drug.
“We are very eager to find out how this new drug compares to a therapy that is currently available,” the principal researcher of the study, Mara J. Horwitz, MD, said in a UPMC press release. “Our previous studies suggest that it may increase bone density more dramatically with fewer side effects, but this is the first head-to-head comparison.”
Horwitz and colleagues will study the results of 105 participants who will be randomly assigned to receive either the FDA-approved teriparatide (Forteo, Eli Lilly) or parathyroid hormone-related protein (PTHrP). Osteotrophin, LLC holds the patent for the experimental osteoporosis drug, according to the press release.
Both treatments are anabolic agents that occur naturally in the body and are given as daily injections. However, PTHrP appears to simulate bone formation without increasing bone resorption.
“When we studied PTHrP several years ago in small numbers of postmenopausal women with osteoporosis, we found that bone density increased by nearly 5% after only 3 months of treatment,” senior researcher Andrew F. Stewart, MD, said in the release. “And even at the highest doses, the side effects were negligible.”
In a study appearing in the online version of the Journal of Clinical Endocrinology and Metabolism last week, the researchers detailed the maximum tolerable dose and therapeutic window of PTHrP. In addition, they showed that tolerable doses of the experimental drug stimulated bone formation after three weeks of treatment.
The National Institutes of Health and the University of Pittsburgh Clinical Translational Sciences Award provided funding for the research.