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Safety of parathyroid hormone for the treatment of osteoporosis

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Abstract

Teriparatide (recombinant human 1-34 parathyroid hormone) has been registered for the treatment of postmenopausal osteoporosis and osteoporosis in men for more than 5 years, whereas 1-84 parathyroid hormone has just recently been registered in Europe for osteoporosis management. Therefore, more data are available regarding the long-term safety of teriparatide. The issues to be considered are the effects of the registered dose of teriparatide (20 µg/day) on the incidence of hypercalcemia, hypercalciuria, and hyperuricemia, and the US Food and Drug Administration’s “black-box” warning regarding osteogenic sarcoma in the rat model. This review discusses these issues and provides the author’s extensive clinical experience and advice on the use of teriparatide in clinical practice.

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References and Recommended Reading

  1. 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, 344:1434–1441.

    Article  PubMed  CAS  Google Scholar 

  2. 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.

    Article  PubMed  CAS  Google Scholar 

  3. Saag KG, Shane E, Boonen S, et al.: Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med 2007, 357:2028–2039.

    Article  PubMed  CAS  Google Scholar 

  4. Greenspan SL, Bone HG, Macciott TB, et al.: Preventing the first vertebral fracture in postmenopausal women with low bone mass using PTH (1-84): results from the TOP study. J Bone Miner Res 2005, 20(Suppl 1):S56.

    Google Scholar 

  5. Miller PD, Bilezikian JP, Deal C, Harris ST: Clinical use of teriparatide in the real world: initial insights. Endocr Pract 2004, 10:139–148.

    PubMed  Google Scholar 

  6. Hodsman AB, Bauer DC, Dempster DW, et al.: Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use. Endocr Rev 2005, 26:688–703.

    Article  PubMed  CAS  Google Scholar 

  7. Tashjian AH, Gagel RF: Teriparatide (human parathyroid hormone 1-34): two and a half years of experience on the use and safety of the drug for the treatment of osteoporosis. J Bone Miner Res 2006, 21:354–365.

    Article  PubMed  CAS  Google Scholar 

  8. Miller PD, Silverman S, Gold DT, et al.: Rationale, objectives, and design of the Direct Analysis of Nonvertebral fracture in the Community Experience (DANCE) study. Osteoporos Int 2006, 17:85–90.

    Article  PubMed  Google Scholar 

  9. Wagman R, Miller PD: The use of teriparatide and PTH (1-84) for the treatment of osteoporosis. Clin Rev Bone Mineral Metab 2006, 4:1–13.

    Article  Google Scholar 

  10. Miller PD, Shergy WJ, Body JJ, et al.: Long-term reduction of back pain risk in women with osteoporosis treated with teriparatide compared with alendronate. J Rheumatol 2005, 32:1556–1562.

    PubMed  CAS  Google Scholar 

  11. Genant HK, Halse J, Briney WG, et al.: The effects of teriparatide on the incidence of back pain in postmenopausal women with osteoporosis. Curr Med Res Opin 2005, 21:1027–1034.

    Article  PubMed  CAS  Google Scholar 

  12. Nevitt MC, Chen P, Dore RK, et al.: Reduced risk of back pain following teriparatide treatment: a meta-analysis. Osteoporos Int 2006, 17:273–280.

    Article  PubMed  Google Scholar 

  13. Canalis E, Giustina A, Bilezikian JP: Mechanisms of anabolic therapies for osteoporosis. N Engl J Med 2007, 357:905–916.

    Article  PubMed  CAS  Google Scholar 

  14. McClung M, San Martin J, Miller PD, et al.: Teriparatide and alendronate increase bone mass by opposite effects on bone remodeling. Arch Intern Med 2005, 165:1762–1768.

    Article  PubMed  CAS  Google Scholar 

  15. Chen P, Miller PD, Delmas PD, et al.: Change in lumbar spine bone mineral density and vertebral fracture risk reduction in teriparatide-treated postmenopausal women with osteoporosis. J Bone Miner Res 2006, 21:1785–1790.

    Article  PubMed  CAS  Google Scholar 

  16. Chen P, Satterwhite JH, Licata AA, et al.: Early changes in biochemical markers of bone formation predict BMD response to teriparatide in postmenopausal osteoporosis. J Bone Miner Res 2005, 20:962–970.

    Article  PubMed  CAS  Google Scholar 

  17. Chen P, Miller PD, Recker RR, et al.: Increases in BMD correlate with improvements in bone microarchitecture with teriparatide treatment in postmenopausal women with osteoporosis. J Bone Miner Res 2007, 22:1173–1180.

    Article  PubMed  CAS  Google Scholar 

  18. Dempster DW, Cosman F, Kurland AS, et al.: Effects of daily treatment with parathyroid hormone on bone microarchitecture and turnover in patients with osteoporosis: a paired biopsy study. J Bone Miner Res 2001, 16:1846–1853.

    Article  PubMed  CAS  Google Scholar 

  19. Jiang Y, Zhao J, Mitlak BH, et al.: Recombinant human parathyroid hormone (1–34) [teriparatide] improves both cortical and cancellous bone structure. J Bone Miner Res 2003, 18:1932–1941.

    Article  PubMed  CAS  Google Scholar 

  20. Zanchetta JR, Bogado CE, Ferretti JL, et al.: Effects of teriparatide [recombinant human parathyroid hormone (1–34)] on cortical bone in postmenopausal women with osteoporosis. J Bone Miner Res 2003, 18:539–543.

    Article  PubMed  CAS  Google Scholar 

  21. Dobnig H, Sipos AA, Jiang Y, et al.: Early changes in biochemical markers of bone formation correlate with improvements in bone structure during teriparatide therapy. J Clin Endocrinol Metab 2005, 90:3970–3977.

    Article  PubMed  CAS  Google Scholar 

  22. Parfitt AM: Parathyroid hormone and periosteal bone expansion. J Bone Miner Res 2002, 17:1741–1743.

    Article  PubMed  CAS  Google Scholar 

  23. Bringhurst FR: Physiologic actions of PTH and PTHRP: II. Renal actions. In The Parathyroids: Basic and Clinical Concepts. Edited by Bilizikian JP, Marcus R, Levine MA. New York: Academic Press; 2001:227–244.

    Google Scholar 

  24. Strewler GJ: Physiologic actions of PTH and PTHrP: I. Skeletal actions. In The Parathyroids: Basic and Clinical Concepts. Edited by Bilizikian JP, Marcus R, Levine MA. New York: Academic Press; 2001:213–226.

    Google Scholar 

  25. Bilezikian JP, Silverberg SJ: Primary hyperparathyroidism. In Primer on the Metabolic Bone Diseases and Disorders of Mineral Metabolism, edn 5. Edited by Favus MJ. Washington, DC: American Society for Bone and Mineral Research; 2006:230–235.

    Google Scholar 

  26. Hruska KA, Teitelbaum SL: Renal osteodystrophy. N Engl J Med 1995, 333:166–172.

    Article  PubMed  CAS  Google Scholar 

  27. Slatopolsky E, Brown A, Dusso A: Pathogenesis of secondary hyperparathyroidism. Kidney Int Suppl 1999, 73:S14–S19.

    Article  PubMed  CAS  Google Scholar 

  28. Holick M: Vitamin D deficiency. N Engl J Med 2007, 357:266–281.

    Article  PubMed  CAS  Google Scholar 

  29. Heaney RP: The vitamin D requirement in health and disease. J Steroid Biochem Mol Biol 2005, 97:13–19.

    Article  PubMed  CAS  Google Scholar 

  30. Coe FL, Favus MJ, Crockett T, et al.: Effects of low-calcium diet on urine calcium excretion, parathyroid function and serum 1,25(OH)2D3 levels in patients with idiopathic hypercalciuria and in normal subjects. Am J Med 1982, 72:25–32.

    Article  PubMed  CAS  Google Scholar 

  31. Heaney RP, Recker RR, Ryan RA: Urinary calcium in perimenopausal women: normative values. Osteoporos Int 1999, 9:13–18.

    Article  PubMed  CAS  Google Scholar 

  32. Bushinsky DA: Nephrolithiasis. J Am Soc Nephrol 1998, 9:917–924.

    PubMed  CAS  Google Scholar 

  33. Miller PD, Bilezikian JP, Diaz-Curiel M, et al.: Occurrence of hypercalciuria in patients treated with teriparatide. J Clin Endocrinol Metab 2007, 92:3535–3541.

    Article  PubMed  CAS  Google Scholar 

  34. 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, 30:312–321.

    Article  PubMed  CAS  Google Scholar 

  35. Vahle JL, Long GG, Ma YL, Sato M: Bone neoplasms in F344 rats given teriparatide [rhPTH (1–34)] are dependent on duration of treatment and dose. Toxicol Pathol 2004, 32:426–438.

    Article  PubMed  CAS  Google Scholar 

  36. Wilker CE, Jolette J, Smith SY, et al.: No observable carcinogenic effect dose level identified in Fischer 344 rats following daily treatment with PTH (1-84) for 2 years: role of the c-terminal PTH receptor? J Bone Miner Res 2004, 19(Suppl 1):S98.

    Google Scholar 

  37. Harper K, Krege JH, Marcus R, Mitlak BH: Osteosarcoma and teriparatide? J Bone Miner Res 2007, 22:334.

    Article  PubMed  Google Scholar 

  38. Damron TA, Ward WG, Stewart A: Osteosarcoma, chondrosarcoma, and Ewing’s sarcoma: National Cancer Data Base Report. Clin Orthop Relat Res 2007, 459:40–47.

    Article  PubMed  Google Scholar 

  39. Kalra S, Grimer RJ, Spooner D, et al.: Radiation-induced sarcoma of bone: factors that determine outcome. J Bone Joint Surg Br 2007, 89:808–813.

    Article  PubMed  CAS  Google Scholar 

  40. Taghian A, de Vathaire F, Terrier P, et al.: Long-term risk of sarcoma following radiation treatment for breast cancer. Int J Radiat Oncol Biol Phys 1991, 21:361–367.

    PubMed  CAS  Google Scholar 

  41. Kirova YM, Vilcoq JR, Asselain B, et al.: Radiationinduced sarcomas after radiotherapy for breast carcinoma: a large-scale, single institution review. Cancer 2005, 104:856–863.

    Article  PubMed  Google Scholar 

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Correspondence to Paul D. Miller.

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Miller, P.D. Safety of parathyroid hormone for the treatment of osteoporosis. Curr Osteoporos Rep 6, 12–16 (2008). https://doi.org/10.1007/s11914-008-0003-y

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