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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" (2010) Journal of Clinical Endocrinology and Metabolism. 95(1):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. Copyright © 2010 by The Endocrine Society.

Registro:

Documento: Artículo
Título:Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women
Autor: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.
Filiación:Regional Bone Center, Helen Hayes Hospital, Route 9W, New York, NY 10993, United States
Columbia College of Physicians and Surgeons, Columbia University, New York, NY 10032, United States
Aging Center, Medicine and Rheumatology, University of California at Davis Medical Center, Sacramento, CA 95817, United States
Bethesda Health Research Center, Bone Health Center of Bethesda, Bethesda, MD 20817, United States
Instituto de Investigaciones Metabolicas, Ciudad Autonoma de Buenos Aires, 1428 Buenos Aires, Argentina
Hospital Universitario, Dr. Jose Eleuterio Gonzalez, 64460 Monterrey, Mexico
Zosano Pharma Inc., Fremont, CA 94555, United States
Palabras clave: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
Año:2010
Volumen:95
Número:1
Página de inicio:151
Página de fin:158
DOI: http://dx.doi.org/10.1210/jc.2009-0358
Título revista:Journal of Clinical Endocrinology and Metabolism
Título revista abreviado:J. Clin. Endocrinol. Metab.
ISSN:0021972X
CODEN:JCEMA
CAS:parathyroid hormone[1-34], 12583-68-5, 52232-67-4
Registro:https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_0021972X_v95_n1_p151_Cosman

Referencias:

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Citas:

---------- APA ----------
Cosman, F., Lane, N.E., Bolognese, M.A., Zanchetta, J.R., Garcia-Hernandez, P.A., Sees, K., Matriano, J.A.,..., 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.
http://dx.doi.org/10.1210/jc.2009-0358
---------- CHICAGO ----------
Cosman, F., Lane, N.E., Bolognese, M.A., Zanchetta, J.R., Garcia-Hernandez, P.A., Sees, K., et al. "Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women" . Journal of Clinical Endocrinology and Metabolism 95, no. 1 (2010) : 151-158.
http://dx.doi.org/10.1210/jc.2009-0358
---------- MLA ----------
Cosman, F., Lane, N.E., Bolognese, M.A., Zanchetta, J.R., Garcia-Hernandez, P.A., Sees, K., et al. "Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women" . Journal of Clinical Endocrinology and Metabolism, vol. 95, no. 1, 2010, pp. 151-158.
http://dx.doi.org/10.1210/jc.2009-0358
---------- VANCOUVER ----------
Cosman, F., Lane, N.E., Bolognese, M.A., Zanchetta, J.R., Garcia-Hernandez, P.A., Sees, K., et al. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J. Clin. Endocrinol. Metab. 2010;95(1):151-158.
http://dx.doi.org/10.1210/jc.2009-0358