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, Peter E. Daddona

Research output: Contribution to journalArticle

114 Citations (Scopus)

Abstract

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:ATPTD 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 spineBMDvs. 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.

Original languageEnglish (US)
Pages (from-to)151-158
Number of pages8
JournalJournal of Clinical Endocrinology and Metabolism
Volume95
Issue number1
DOIs
StatePublished - Jan 2010

Fingerprint

Teriparatide
Cutaneous Administration
Bone Density
Transdermal Patch
Minerals
Bone
Placebos
Osteoporosis
Collagen Type I
Pelvic Bones
Anabolic Agents
Injections
Spine
Parathyroid Hormone
Bone Remodeling
Wear of materials
Hypercalcemia
Therapeutics
Safety

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Endocrinology
  • Biochemistry, medical
  • Endocrinology, Diabetes and Metabolism

Cite this

Cosman, F., Lane, N. E., Bolognese, M. A., Zanchetta, J. R., Garcia-Hernandez, P. A., Sees, K., ... Daddona, P. E. (2010). Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. Journal of Clinical Endocrinology and Metabolism, 95(1), 151-158. https://doi.org/10.1210/jc.2009-0358

Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. / Cosman, Felicia; Lane, Nancy E; Bolognese, Michael A.; Zanchetta, Jose R.; Garcia-Hernandez, Pedro A.; Sees, Karen; Matriano, James A.; Gaumer, Kim; Daddona, Peter E.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 95, No. 1, 01.2010, p. 151-158.

Research output: Contribution to journalArticle

Cosman, F, Lane, NE, Bolognese, MA, Zanchetta, JR, Garcia-Hernandez, PA, Sees, K, Matriano, JA, Gaumer, K & Daddona, PE 2010, 'Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women', Journal of Clinical Endocrinology and Metabolism, vol. 95, no. 1, pp. 151-158. https://doi.org/10.1210/jc.2009-0358
Cosman, Felicia ; Lane, Nancy E ; Bolognese, Michael A. ; Zanchetta, Jose R. ; Garcia-Hernandez, Pedro A. ; Sees, Karen ; Matriano, James A. ; Gaumer, Kim ; Daddona, Peter E. / Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. In: Journal of Clinical Endocrinology and Metabolism. 2010 ; Vol. 95, No. 1. pp. 151-158.
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abstract = "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:ATPTD 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 spineBMDvs. 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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