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news.Zosano Pharma, a privately held pharmaceutical company, has announced positive results of its Phase II study of Zosano PTH Patch, a proprietary transdermal patch formulation of parathyroid hormone for the treatment of established osteoporosis.
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In the study, treatment with the Zosano PTH patch was significantly better than placebo in increasing BMD (bone mineral density) values measured for the lumbar spine, which was the primary endpoint. Overall, treatment with the Zosano PTH patch was very well tolerated.
The Phase II program evaluated the safety and bone mineral density changes of three doses of the Zosano PTH Patch formulation relative to placebo and injectable Forteo in postmenopausal women. The study enrolled 165 patients between 50 and 81 years of age with severe osteoporosis and was conducted at multiple sites across North and South America.
Gail Schulze, Zosano’s chairman and CEO, said: “Zosano is pleased to present important data from our first long-term trial assessing bone mineral density improvements with the Zosano PTH Patch, and we look forward to further exploring the products’ clinical advantage in our Phase III program.”