Safety, tolerability and pharmacokinetic study of recombinant human parathyroid hormone [rhPTH (1-84)] in Chinese healthy volunteers

Journal of Huazhong University of Science and Technology - Medical Science

Volumn 29, Issue 4, 2009, Pages 431-434

  Li, Qian ^a   Qiao, Jian ^a   Deng, Jungang ^a   Zeng, Tianshu ^a   Zhou, Piqi ^a   Li, Weiyong ^a  

^a HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY   (China)

Author keywords

Pharmacokinetics; Recombinant human parathyroid hormones; Safety; Tolerability

Indexed keywords

PARATHYROID HORMONE; RECOMBINANT PROTEIN;

ADULT; ARTICLE; BLOOD; CHINA; CLINICAL TRIAL; HUMAN; MALE;

ADULT; CHINA; HUMANS; MALE; PARATHYROID HORMONE; RECOMBINANT PROTEINS; YOUNG ADULT;

EID: 68949093549     PISSN: 16720733     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11596-009-0408-6     Document Type: Article

References (25)

1. J.F. Habener M. Rosenblatt Potts Jr 1984 Parathyroid hormone: biochemical aspects of biosynthesis, secretion, action, and metabolism Physiol Rev 64 3 985 1053
2. C.G. Liang K.J. Li H. Zhang 2005 Quality research of the recombinant human parathyroid hormone Chin J Pharm Anal 25 2 215 219
3. C. Crandall 2002 Parathyroid hormone for treatment of osteoporosis Arch Intern Med 162 20 2297 2309
4. M. Mannstadt H. Juppner T.J. Gradella 1999 Receptors for PTH and PTHrP: their biological importance and functional properties Am J Physiol 277 5Pt2 F665 F675
5. D.D. MA G.F. Ji Z.H. Xu 2002 Studies on the secondary structure and function of PTH (1-34) Tianjin Yike Daxue Xuebao (Chinese) 8 3 314 373
6. T.J. Gardella H. Jüppner 2000 Interaction of PTH and PTHrP with their receptors Rev Endocr Metab Disord 1 4 317 329
7. S.J. Warden D.E. Komatsu J. Rydberg 2009 Recombinant human parathyroid hormone (PTH 1-34) and low-intensity pulsed ultrasound have contrasting additive effects during fracture healing Bone 44 3 485 494
8. K. Nakajima K. Nohtomi M. Sato 2009 PTH (7-84) inhibits PTH (1-34)-induced 1, 25-(OH) 2D3 production in murine renal tubules Biochem Biophys Res Commun 381 2 283 287
9. K. Tomida T. Hamano S. Mikami 2009 Serum 25-hydroxyvitamin D as an independent determinant of 1-84 PTH and bone mineral density in non-diabetic predialysis CKD patients Bone 44 4 678 683
10. K. Ueda Y. Yamanaka D. Harada 2007 PTH has the potential to rescue disturbed bone growth in achondroplasia Bone 41 1 13 18
11. T. Ogawa H. Yamagiwa T. Hayami 2002 Human PTH(1-34) induces longitudinal bone growth in rats J Bone Miner Metab 20 2 83 90
12. G.L. LU K.Q. Zhang W. Tang 2003 Effects of Parathyroid Hormone on the Expression of Transforming Growth Factor-B1 in Rats Acta Univ Med Nanjing [Natural Science] 24 4 371 372
13. W.F. Jin S.Z. Gu J.J. Gao 2006 Effects of bone formation on culture osteoblasts with rhPTH (1-34) in vitro Fudan Univ J Med Sci 33 6 815 818
14. W.S. Zeng H.M. Liao Z.P. Yang 2003 Analyse the amino acid composition of recombinant human parathyroid hormone 1-34 Pharm Biotechnol (Chinese) 10 2 108 111
15. Adis International Ltd. 2003 ALX111: ALX1-11, parathyroid hormone (1-84)-NPS Allelix, PREOS, PTH, recombinant human parathyroid hormone, rhPTH (1-84) Drug R D 4 4 231 235
16. H.R. Schwietert E.W.J. Groen F.A.E. Sollie 1997 Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH (1-84)] in healthy postmenopausal volunteers Clin Pharmacol Ther 61 360 376
17. Z. Hu H. Niu X. Yang 2006 Recombinant human parathyroid hormone 1-34: Pharmacokinetics, tissue distribution and excretion in rats Inter J Pharm 317 2 144 154
18. E.W.J. Groen H.R. Schwietert S.P. Van Marle 1995 Multiple dose adminstration of recombinant human parathyroid hormone in healthy postmenopausal volunteers Therapie 50 Suppl 525
19. R. Lindsay A. Hodsman H. Genant 1998 A randomized controlled multi-center study of 1-84 hPTH for treatment of postmenopausal osteoporosis Bone 23 Suppl 175
20. R.S. Rittmaster M. Bolognese M.P. Ettinger 2000 Enhancement of bone mass in osteoporotic women with parathyroid hormone followed by alendronate J Clin Endocr Metab 85 6 2129 2134
21. G.C. LU J.H. She B.J. Yuan 2003 Pharmacological study on the safety of recombinant parathyroid hormone Chin J New Drugs 12 10 833 836
22. P.A. Friedman W.G. Goodman 2006 PTH (1-84)/PTH (7-84): a balance of power Am J Physiol Renal Physiol 290 5 F975 F984
23. J.J. Kazama T. Omori I. Ei 2003 Circulating 1-84 PTH and large C-terminal PTH fragment levels in uremia Clin Exp Nephrol 7 2 114 119
24. M.W. Seibel D.A. Lade J.R. Hartke 1996 Validation and application of an immunoradiometric assay for the determination of human parathyroid hormone fragment 1-34 in dog plasma following subcutaneous and intravenous administration J Pharm Biomed Anal 14 12 1699 1707
25. R. Lindsay H. Zhou F. Cosman 2007 Effects of a one-month treatment with PTH(1-34) on bone formation on cancellous, endocortical, and periosteal surfaces of the human ilium J Bone Miner Res 22 4 495 502