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Drug profile

PTH(1-84) replacement therapy for the treatment of hypoparathyroidism

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References

  • Bilezikian JP, Khan A, Potts JTJr, et al. Hypoparathyroidism in the adult: epidemiology, diagnosis, pathophysiology, target-organ involvement, treatment, and challenges for future research. J Bone Miner Res 2011;26:2317-37
  • Cusano NE, Rubin MR, Sliney JJr, Bilezikian JP. Mini-review: new therapeutic options in hypoparathyroidism. Endocrine 2012;41:410-14
  • Shoback D. Clinical practice. Hypoparathyroidism. N Engl J Med 2008;359:391-403
  • Mitchell DM, Regan S, Cooley MR, et al. Long-term follow-up of patients with hypoparathyroidism. J Clin Endocrinol Metab 2012;97:4507-14
  • Powers J, Joy K, Ruscio A, Lagast H. Prevalence and incidence of hypoparathyroidism in the United States using a large claims database. J Bone Miner Res 2013;28:2570-6
  • Sikjaer T, Rejnmark L, Rolighed L, et al. The effect of adding PTH(1-84) to conventional treatment of hypoparathyroidism: a randomized, placebo-controlled study. J Bone Miner Res 2011;26:2358-70
  • Mannstadt M, Clarke BL, Vokes T, et al. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol 2013;1:275-83
  • Rubin MR, Sliney JJr, McMahon DJ, et al. Therapy of hypoparathyroidism with intact parathyroid hormone. Osteoporos Int 2010;21:1927-34
  • Cusano NE, Rubin MR, McMahon DJ, et al. Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety. J Clin Endocrinol Metab 2013;98:137-44
  • Potts JTJr, Kronenberg HM, Habener JF, Rich A. Biosynthesis of parathyroid hormone. Ann N Y Acad Sci 1980;343:38-55
  • Lee SK, Lorenzo JA. Parathyroid hormone stimulates TRANCE and inhibits osteoprotegerin messenger ribonucleic acid expression in murine bone marrow cultures: correlation with osteoclast-like cell formation. Endocrinology 1999;140:3552-61
  • Khosla S. Minireview: the OPG/RANKL/RANK system. Endocrinology 2001;142:5050-5
  • Huang JC, Sakata T, Pfleger LL, et al. PTH differentially regulates expression of RANKL and OPG. J Bone Miner Res 2004;19:235-44
  • Locklin RM, Khosla S, Turner RT, Riggs BL. Mediators of the biphasic responses of bone to intermittent and continuously administered parathyroid hormone. J Cell Biochem 2003;89:180-90
  • Tobimatsu T, Kaji H, Sowa H, et al. Parathyroid hormone increases beta-catenin levels through Smad3 in mouse osteoblastic cells. Endocrinology 2006;147:2583-90
  • Iwaniec UT, Wronski TJ, Liu J, et al. PTH stimulates bone formation in mice deficient in Lrp5. J Bone Miner Res 2007;22:394-402
  • Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001;344:1434-41
  • Albright F, Ellsworth R. Studies on the physiology of the parathyroid GLANDS: I. Calcium and phosphorus studies on a case of idiopathic hypoparathyroidism. J Clin Invest 1929;7:183-201
  • Winer KK, Ko CW, Reynolds JC, et al. Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium. J Clin Endocrinol Metab 2003;88:4214-20
  • Winer KK, Sinaii N, Peterson D, et al. Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism. J Clin Endocrinol Metab 2008;93:3389-95
  • Winer KK, Sinaii N, Reynolds J, et al. Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1-34 versus calcitriol and calcium. J Clin Endocrinol Metab 2010;95:2680-8
  • Winer KK, Yanovski JA, Cutler GBJr. Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism. JAMA 1996;276:631-6
  • Winer KK, Yanovski JA, Sarani B, Cutler GBJr. A randomized, cross-over trial of once-daily versus twice-daily parathyroid hormone 1-34 in treatment of hypoparathyroidism. J Clin Endocrinol Metab 1998;83:3480-6
  • Winer KK, Zhang B, Shrader JA, et al. Synthetic Human Parathyroid Hormone 1-34 Replacement Therapy: a Randomized Crossover Trial Comparing Pump Versus Injections in the Treatment of Chronic Hypoparathyroidism. J Clin Endocrinol Metab 2011;97:391-9
  • Gafni RI, Brahim JS, Andreopoulou P, et al. Daily parathyroid hormone 1-34 replacement therapy for hypoparathyroidism induces marked changes in bone turnover and structure. J Bone Miner Res 2012;27:1811-20
  • Winer KK, Fulton KA, Albert PS, Cutler GB. Jr. Effects of Pump versus Twice-Daily Injection Delivery of Synthetic Parathyroid Hormone 1-34 in Children with Severe Congenital Hypoparathyroidism. J Pediatr 2014;165:556-63; e551
  • Lindsay R, Nieves J, Henneman E, et al. Subcutaneous administration of the amino-terminal fragment of human parathyroid hormone-(1-34): kinetics and biochemical response in estrogenized osteoporotic patients. J Clin Endocrinol Metab 1993;77:1535-9
  • Schwietert HR, Groen EW, Sollie FA, Jonkman JH. Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH(1-84)] in healthy postmenopausal volunteers. Clin Pharmacol Ther 1997;61:360-76
  • Fox J, Wells D, Garceau R. Relationships between pharmacokinetic profile of human pth(1-84) and serum calcium response in postmenopausal women following 4 different methods of administration [abstract MO0173] In: Program of the 33rd Annual Meeting of the American Society of Bone and Mineral Research;2011. San Diego, CA
  • Sikjaer T, Amstrup AK, Rolighed L, et al. PTH(1-84) replacement therapy in hypoparathyroidism: a randomized controlled trial on pharmacokinetic and dynamic effects after 6 months of treatment. J Bone Miner Res 2013;28:2232-43
  • Clarke BL, Kay Berg J, Fox J, et al. Pharmacokinetics and pharmacodynamics of subcutaneous recombinant parathyroid hormone (1-84) in patients with hypoparathyroidism: an open-label, single-dose, phase I study. Clin Ther 2014;36:722-36
  • Rubin MR, Dempster DW, Zhou H, et al. Dynamic and structural properties of the skeleton in hypoparathyroidism. J Bone Miner Res 2008;23:2018-24
  • Rubin MR, Dempster DW, Kohler T, et al. Three dimensional cancellous bone structure in hypoparathyroidism. Bone 2010;46:190-5
  • Mendonca ML, Pereira FA, Nogueira-Barbosa MH, et al. Increased vertebral morphometric fracture in patients with postsurgical hypoparathyroidism despite normal bone mineral density. BMC Endocr Disord 2013;13:1
  • Underbjerg L, Sikjaer T, Mosekilde L, Rejnmark L. Post-Surgical Hypoparathyroidism - Risk of Fractures, Psychiatric Diseases, Cancer, Cataract, and Infections. J Bone Miner Res 2014. [Epub ahead of print]
  • Silverberg SJ, Shane E, de la Cruz L, et al. Skeletal disease in primary hyperparathyroidism. J Bone Miner Res 1989;4:283-91
  • Bilezikian JP, Brandi ML, Rubin M, Silverberg SJ. Primary hyperparathyroidism: new concepts in clinical, densitometric and biochemical features. J Intern Med 2005;257:6-17
  • Dempster DW, Muller R, Zhou H, et al. Preserved three-dimensional cancellous bone structure in mild primary hyperparathyroidism. Bone 2007;41:19-24
  • Rubin MR, Cosman F, Lindsay R, Bilezikian JP. The anabolic effects of parathyroid hormone. Osteoporos Int 2002;13:267-77
  • Sikjaer T, Rejnmark L, Thomsen JS, et al. Changes in 3-dimensional bone structure indices in hypoparathyroid patients treated with PTH(1-84): a randomized controlled study. J Bone Miner Res 2012;27:781-8
  • Rubin MR, Dempster DW, Sliney JJr, et al. PTH(1-84) administration reverses abnormal bone-remodeling dynamics and structure in hypoparathyroidism. J Bone Miner Res 2011;26:2727-36
  • Arlt W, Fremerey C, Callies F, et al. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol 2002;146:215-22
  • Cusano NE, Rubin MR, McMahon DJ, et al. The effect of PTH(1-84) on quality of life in hypoparathyroidism. J Clin Endocrinol Metab 2013;98:2356-61
  • Sikjaer T, Rolighed L, Hess A, et al. Effects of PTH(1-84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial. Osteoporos Int 2014;25(6):1717-26
  • Cusano NE, Rubin MR, McMahon DJ, et al. PTH(1-84) is associated with improved quality of life in hypoparathyroidism through 5 years of therapy. J Clin Endocrinol Metab 2014;99(10):3694-9
  • Ware JEJr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83
  • RAND Health. Medical Outcomes Study. 36-Item short form survey scoring instructions. Available from: wwwrandorg/health/surveys_tools/mos/mos_core_36item_scoringhtml 2010
  • Sikjaer T, Rolighed L, Hess A, et al. Effects of PTH(1-84) therapy on muscle function and quality of life in hypoparathyroidism: results from a randomized controlled trial. Osteoporos Int 2014;25:1717-26
  • Vahle JL, Sato M, Long GG, et al. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety. Toxicol Pathol 2002;30:312-21
  • Jolette J, Wilker CE, Smith SY, et al. Defining a noncarcinogenic dose of recombinant human parathyroid hormone 1-84 in a 2-year study in Fischer 344 rats. Toxicol Pathol 2006;34:929-40
  • Orwoll ES, Scheele WH, Paul S, et al. The effect of teriparatide [human parathyroid hormone (1-34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 2003;18:9-17
  • Saag KG, Zanchetta JR, Devogelaer JP, et al. Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis Rheum 2009;60:3346-55
  • Greenspan SL, Bone HG, Ettinger MP, et al. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med 2007;146:326-39
  • Andrews EB, Gilsenan AW, Midkiff K, et al. The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years. J Bone Miner Res 2012;27:2429-37
  • Cipriani C, Irani D, Bilezikian JP. Safety of osteoanabolic therapy: a decade of experience. J Bone Miner Res 2012;27:2419-28
  • Daddona PE, Matriano JA, Mandema J, Maa YF. Parathyroid hormone (1-34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis. Pharm Res 2011;28:159-65
  • Hattersley G, Bilezikian JP, Guerriero J, et al. Bone Anabolic Efficacy and Safety of BA058, a Novel Analog of hPTHrP: Results from a Phase 2 Clinical Trial in Postmenopausal Women with Osteoporosis. In: The Endocrine Society’s 94th Annual Meeting and Expo; 2012. Houston, TX OR08-1

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