Human trial of promising new osteoporosis drug to be launched

January 15th, 2010 - 2:57 pm ICT by ANI  

Washington, January 15 (ANI): Researchers have developed a new drug that holds great promise for building bones weakened by osteoporosis.

Endocrinologists at the University of Pittsburgh School of Medicine and UPMC are keen to find results after testing the drugs on humans.

As part of the trial, 105 participants will be randomly assigned to receive either teriparitide, a drug that already is FDA-approved for osteoporosis treatment, or an experimental agent called parathyroid hormone-related protein.

“We are very eager to find out how this new drug compares to a therapy that is currently available. 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,” said Mara J. Horwitz, an assistant Professor of Medicine in the Division of Endocrinology and Metabolism, Pitt School of Medicine.

In osteoporosis, the process of resorption, in which the bone breaks down and rebuild at cellular level, gets disturbed.

Drugs, such as alendronate and raloxifene work by decreasing bone resorption.

They can improve bone density by two to 10 percent over several years to a decade and reduce fractures.

However, the experimental drug parathyroid hormone-related protein (PTHrP), appears to be unique in its ability to stimulate bone formation without simultaneously increasing bone breakdown.

Senior investigator Andrew F. Stewart, M.D., professor and chief of the Division of Endocrinology and Metabolism, Department of Medicine, Pitt School of Medicine, said: “When we studied PTHrP several years ago in small numbers of postmenopausal women with osteoporosis, we found that bone density increased by nearly 5 percent after only three months of treatment. And even at the highest doses, the side effects were negligible.”

The study has been published online in the Journal of Clinical Endocrinology and Metabolism. (ANI)

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