Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women
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 desirab...
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todo:paper_0021972X_v95_n1_p151_Cosman2023-10-03T14:25:05Z Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women Cosman, F. Lane, N.E. Bolognese, M.A. Zanchetta, J.R. Garcia-Hernandez, P.A. Sees, K. Matriano, J.A. Gaumer, K. Daddona, P.E. carboxy terminal telopeptide parathyroid hormone[1-34] placebo procollagen procollagen type i n terminal propeptide unclassified drug adult aged area under the curve arthralgia article bleeding bone density bone turnover calcium blood level clinical trial controlled clinical trial controlled study creatinine urine level dizziness dose response drug absorption drug dose comparison drug efficacy drug hypersensitivity drug safety drug tolerability drug withdrawal edema erythema female human hypercalcemia hypercalciuria hyperpigmentation hypotension injection site erythema lumbar spine major clinical study maximum plasma concentration multicenter study nausea nephrolithiasis osteoporosis pain postmenopause priority journal randomized controlled trial side effect skin infection syncope tachycardia 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. Copyright © 2010 by The Endocrine Society. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_0021972X_v95_n1_p151_Cosman |
| institution |
Universidad de Buenos Aires |
| institution_str |
I-28 |
| repository_str |
R-134 |
| collection |
Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) |
| topic |
carboxy terminal telopeptide parathyroid hormone[1-34] placebo procollagen procollagen type i n terminal propeptide unclassified drug adult aged area under the curve arthralgia article bleeding bone density bone turnover calcium blood level clinical trial controlled clinical trial controlled study creatinine urine level dizziness dose response drug absorption drug dose comparison drug efficacy drug hypersensitivity drug safety drug tolerability drug withdrawal edema erythema female human hypercalcemia hypercalciuria hyperpigmentation hypotension injection site erythema lumbar spine major clinical study maximum plasma concentration multicenter study nausea nephrolithiasis osteoporosis pain postmenopause priority journal randomized controlled trial side effect skin infection syncope tachycardia |
| spellingShingle |
carboxy terminal telopeptide parathyroid hormone[1-34] placebo procollagen procollagen type i n terminal propeptide unclassified drug adult aged area under the curve arthralgia article bleeding bone density bone turnover calcium blood level clinical trial controlled clinical trial controlled study creatinine urine level dizziness dose response drug absorption drug dose comparison drug efficacy drug hypersensitivity drug safety drug tolerability drug withdrawal edema erythema female human hypercalcemia hypercalciuria hyperpigmentation hypotension injection site erythema lumbar spine major clinical study maximum plasma concentration multicenter study nausea nephrolithiasis osteoporosis pain postmenopause priority journal randomized controlled trial side effect skin infection syncope tachycardia Cosman, F. Lane, N.E. Bolognese, M.A. Zanchetta, J.R. Garcia-Hernandez, P.A. Sees, K. Matriano, J.A. Gaumer, K. Daddona, P.E. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| topic_facet |
carboxy terminal telopeptide parathyroid hormone[1-34] placebo procollagen procollagen type i n terminal propeptide unclassified drug adult aged area under the curve arthralgia article bleeding bone density bone turnover calcium blood level clinical trial controlled clinical trial controlled study creatinine urine level dizziness dose response drug absorption drug dose comparison drug efficacy drug hypersensitivity drug safety drug tolerability drug withdrawal edema erythema female human hypercalcemia hypercalciuria hyperpigmentation hypotension injection site erythema lumbar spine major clinical study maximum plasma concentration multicenter study nausea nephrolithiasis osteoporosis pain postmenopause priority journal randomized controlled trial side effect skin infection syncope tachycardia |
| description |
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. Copyright © 2010 by The Endocrine Society. |
| format |
JOUR |
| author |
Cosman, F. Lane, N.E. Bolognese, M.A. Zanchetta, J.R. Garcia-Hernandez, P.A. Sees, K. Matriano, J.A. Gaumer, K. Daddona, P.E. |
| author_facet |
Cosman, F. Lane, N.E. Bolognese, M.A. Zanchetta, J.R. Garcia-Hernandez, P.A. Sees, K. Matriano, J.A. Gaumer, K. Daddona, P.E. |
| author_sort |
Cosman, F. |
| title |
Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| title_short |
Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| title_full |
Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| title_fullStr |
Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| title_full_unstemmed |
Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| title_sort |
effect of transdermal teriparatide administration on bone mineral density in postmenopausal women |
| url |
http://hdl.handle.net/20.500.12110/paper_0021972X_v95_n1_p151_Cosman |
| work_keys_str_mv |
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| _version_ |
1807314379976212480 |