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This version published online on October 26, 2009
Journal of Clinical Endocrinology & Metabolism , doi:10.1210/jc.2009-0358
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Submitted on February 17, 2009
Accepted on September 29, 2009

Effect of Transdermal Teriparatide Administration on Bone Mineral Density in Postmenopausal Women

Felicia Cosman*, Nancy E. Lane, Michael A. Bolognese, Jose R. Zanchetta, Pedro A. Garcia-Hernandez, Karen Sees, James A. Matriano, Kim Gaumer, and Peter E. Daddona

Regional Bone Center (F.C.), Helen Hayes Hospital, West Haverstraw, New York, New York 10993; Columbia College of Physicians and Surgeons (F.C.), Columbia University, New York, New York 10032; Aging Center, Medicine and Rheumatology (N.E.L.), University of California at Davis Medical Center, Sacramento, California 95817; Bethesda Health Research Center (M.A.B.), Bone Health Center of Bethesda, Bethesda, Maryland 20817; Instituto de Investigaciones Metabolicas (J.R.Z.), Ciudad Autonoma de Buenos Aires, 1428 Buenos Aires, Argentina; Hospital Universitario (P.A.G.-H.), "Dr. Jose Eleuterio Gonzalez," 64460 Monterrey, Mexico; and Zosano Pharma Inc. (K.S., J.A.M., K.G., P.E.D.), Fremont, California 94555

* To whom correspondence should be addressed. E-mail: cosmanf{at}helenhayeshosp.com.

Context: Treatment of osteoporosis with an anabolic agent, teriparatide [human PTH 1-34 (TPTD)], is effective in reducing incident fractures, but patient resistance to daily sc injections has limited its use. A novel transdermal patch, providing a rapid, pulse delivery of TPTD, may provide a desirable alternative.

Objective: The aim of the study was to determine the safety and efficacy of a novel transdermal TPTD patch compared to placebo patch and sc TPTD 20-μg injection in postmenopausal women with osteoporosis.

Design: Our study consisted of 6-month, randomized, placebo-controlled, positive control, multidose daily administration.

Patients: We enrolled 165 postmenopausal women (mean age, 64 yr) with osteoporosis.

Interventions: A TPTD patch with a 20-, 30-, or 40-μg dose or a placebo patch was self-administered daily for 30-min wear time, or 20 μg of TPTD was injected daily.

Outcomes: The primary efficacy measure was mean percentage change in lumbar spine bone mineral density (BMD) from baseline at 6 months.

Results: TPTD delivered by transdermal patch significantly increased lumbar spine BMD vs. placebo patch in a dose-dependent manner at 6 months (P < 0.001). TPTD 40-μg patch increased total hip BMD compared to both placebo patch and TPTD injection (P < 0.05). Bone turnover markers (procollagen type I N-terminal propeptide and C-terminal cross-linked telopeptide of type I collagen) increased from baseline in a dose-dependent manner in all treatment groups and were all significantly different from placebo patch (P < 0.001). All treatments were well tolerated, and no prolonged hypercalcemia was observed.

Conclusion: Transdermal patch delivery of TPTD in postmenopausal women with osteoporosis for 6 months is safe and effective in increasing lumbar spine and total hip BMD.






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