The single dose pharmacokinetic profile of a novel oral human parathyroid hormone formulation in healthy postmenopausal women

Bone

Volumn 50, Issue 4, 2012, Pages 965-973

  Hämmerle, Sibylle P ^a   Mindeholm, Linda ^a   Launonen, Aino ^a   Kiese, Beate ^a   Loeffler, Rolf ^a   Harfst, Evita ^a   Azria, Moise ^a   Arnold, Michel ^a   John, Markus R ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Calcium metabolism; Oral formulation; Osteoporosis; Postmenopausal women; Teriparatide

Indexed keywords

8 (N 2 HYDROXY 5 CHLOROBENZOYL)AMINO CAPRYLIC ACID; CALCIUM ION; DRUG CARRIER; PARATHYROID HORMONE[1-34]; PLACEBO; RECOMBINANT PARATHYROID HORMONE; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BACKACHE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEART PALPITATION; HOT FLUSH; HUMAN; HYPERCALCEMIA; HYPERHIDROSIS; HYPESTHESIA; HYPOTENSION; INSOMNIA; LETHARGY; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NAUSEA; NECK PAIN; NORMAL HUMAN; PHARMACODYNAMICS; POSITIONAL DIZZINESS; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; TACHYCARDIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TOOTH PAIN; UPPER ABDOMINAL PAIN; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; CHEMISTRY, PHARMACEUTICAL; COHORT STUDIES; CONFIDENCE INTERVALS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEALTH; HUMANS; MIDDLE AGED; OCTANOIC ACIDS; POSTMENOPAUSE; TERIPARATIDE; TIME FACTORS;

EID: 84858054312     PISSN: 87563282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bone.2012.01.009     Document Type: Article

References (34)

1. Reid I.R. Anti-resorptive therapies for osteoporosis. Semin Cell Dev Biol 2008, 19(5):473-478. Epub 2008 Aug 7.
2. Potts J.T., Gardella T.J. Progress, paradox, and potential: parathyroid hormone research over five decades. Ann N Y Acad Sci 2007, 1117:196-208.
3. Jüppner H., Abou-Samra A.B., Freeman M., Kong X.F., Schipani E., Richards J., et al. A G protein-linked receptor for parathyroid hormone and parathyroid hormone-related peptide. Science 1991, 254:1024-1026.
4. Reeve J., Hesp R., Williams D., Hulme P., Klenerman L., Zanelli J.M., et al. Anabolic effect of low doses of a fragment of human parathyroid hormone on the skeleton in postmenopausal osteoporosis. Lancet 1976, 1035-1038.
5. Reeve J., Meunier P.J., Parsons J.A., Bernat M., Bijvoet O.L., Courpron P., et al. Anabolic effect of human parathyroid hormone fragment on trabecular bone in involutional osteoporosis: a multicentre trial. Br Med J 1980, 280(6228):1340-1344.
6. Neer R.M., Arnaud C.D., Zanchetta J.R., Prince R., Gaich G.A., Reginster J.Y., 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(19):1434-1441.
7. Greenspan S.L., Bone H.G., Ettinger M.P., Hanley D.A., Lindsay R., Zanchetta J.R., et al. Treatment of Osteoporosis with Parathyroid Hormone Study Group. 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(5):326-339.
8. Bilezikian J.P. Combination anabolic and antiresorptive therapy for osteoporosis: opening the anabolic window. Curr Osteoporos Rep 2008, 6(1):24-30.
9. Glover S.J., Eastell R., McCloskey E.V., Rogers A., Garnero P., Lowery J., et al. Rapid and robust response of biochemical markers of bone formation to teriparatide therapy. Bone 2009, 45(6):1053-1058. Epub 2009 Aug 11.
10. Ziller V., Zimmermann S.P., Kalder M., Ziller M., Seker-Pektas B., Hellmeyer L., et al. Adherence and persistence in patients with severe osteoporosis treated with teriparatide. Curr Med Res Opin 2010, 26(3):675-681.
11. Miki T., Nakatsuka K., Naka H., Masaki H., Imanishi Y., Ito M., et al. Effect and safety of intermittent weekly administration of human parathyroid hormone 1-34 in patients with primary osteoporosis evaluated by histomorphometry and microstructural analysis of iliac trabecular bone before and after 1 year of treatment. J Bone Miner Metab 2004, 22(6):569-576.
12. Kumar S., Matheny C.J., Hoffman S.J., Marquis R.W., Schultz M., Liang X., et al. An orally active calcium-sensing receptor antagonist that transiently increases plasma concentrations of PTH and stimulates bone formation. Bone 2010, 46(2):534-542.
13. John M.R., Widler L., Gamse R., Buhl T., Seuwen K., Breitenstein W., et al. ATF936, a novel oral calcilytic, increases bone mineral density in rats and transiently releases parathyroid hormone in humans. Bone 2011, 49(2):233-241. [Epub 2011 Apr 14].
14. Padhi D., Jang G., Stouch B., Fang L., Posvar E. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res 2011, 26(1):19-26.
15. Leone-Bay A., McInnes C., Wang N., DeMorin F., Achan D., Lercara C., et al. Microsphere formation in a series of derivatized alpha-amino acids: properties, molecular modeling, and oral delivery of salmon calcitonin. J Med Chem 1995, 38(21):4257-4262.
16. Leone-Bay A., Sato M., Paton D., Hunt A.H., Sarubbi D., Carozza M., et al. Oral delivery of biologically active parathyroid hormone. Pharm Res 2001, 18(7):964-970.
17. Buclin T., Cosma Rochat M., Burckhardt P., Azria M., Attinger M. Bioavailability and biological efficacy of a new oral formulation of salmon calcitonin in healthy volunteers. J Bone Miner Res 2002, 17(8):1478-1485.
18. Karsdal M.A., Henriksen K., Bay-Jensen A.C., Molloy B., Arnold M., John M.R., et al. Lessons learned from the development of oral calcitonin: the first tablet formulation of a protein in phase III clinical trials. J Clin Pharmacol 2011, 51(4):460-471. Epub 2010 Jul 21.
19. Mehta N., Stern W., Sturmer A., Bolat B., Chen J., Gilligan J. Oral delivery of PTH analogs by a solid dosage formulation. J Bone Miner Res 2001, 16:S540.
20. Karsdal M.A., Byrjalsen I., Riis B.J., Christiansen C. Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of Salmon Calcitonin. BMC Clin Pharmacol 2008, 8:5. 2008 Sep 9.
21. John M.R., Goodman W.G., Gao P., Cantor T.L., Salusky I.B., Jüppner H. A novel immunoradiometric assay detects full-length human PTH but not amino-terminally truncated fragments: implications for PTH measurements in renal failure. J Clin Endocrinol Metab 1999, 84(11):4287-4290.
22. Piemonte S., Romagnoli E., Cipriani C., Fassino V., Del Fiacco R., Carnevale V., et al. The effect of recombinant PTH(1-34) and PTH(1-84) on serum ionized calcium, 1,25-dihydroxyvitamin D, and urinary calcium excretion: a pilot study. Calcif Tissue Int 2009, 85(4):287-292. Epub 2009 Sep 10.
23. Satterwhite J., Heathman M., Miller P.D., Marín F., Glass E.V., Dobnig H. Pharmacokinetics of teriparatide (rhPTH[1-34]) and calcium pharmacodynamics in postmenopausal women with osteoporosis. Calcif Tissue Int 2010, 87(6):485-492. Epub 2010 Oct 16.
24. Miller P.D. Safety of parathyroid hormone for the treatment of osteoporosis. Curr Osteoporos Rep 2008, 6(1):12-16.
25. Forteo Label Information, accessed on December 4, 2011. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf.
26. Crass M.F., Hulsey S.M., Bulkley T.J. Use of a new pulsatile perfused rat aorta preparation to study the characteristics of the vasodilator effect of parathyroid hormone. J Pharmacol Exp Ther 1988, 245(2):723-734.
27. Bieglmayer C., Prager G., Niederle B. Kinetic analyses of parathyroid hormone clearance as measured by three rapid immunoassays during parathyroidectomy. Clin Chem 2002, 48(10):1731-1738.
28. Miller P.D., Bilezikian J.P., Diaz-Curiel M., Chen P., Marin F., Krege J.H., et al. Occurrence of hypercalciuria in patients with osteoporosis treated with teriparatide. J Clin Endocrinol Metab 2007, 92(9):3535-3541. Epub 2007 Jul 3.
29. Schwietert H.R., Groen E.W., Sollie F.A., Jonkman J.H. Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH(1-84)] in healthy postmenopausal volunteers. Clin Pharmacol Ther 1997, 61(3):360-376.
30. Antoniucci D.M., Sellmeyer D.E., Bilezikian J.P., Palermo L., Ensrud K.E., Greenspan S.L., et al. Elevations in serum and urinary calcium with parathyroid hormone(1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab 2007, 92(3):942-947. Epub 2006 Dec 12.
31. Daddona P.E., Matriano J.A., Mandema J., Maa Y.F. Parathyroid hormone (1-34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis. Pharm Res 2011, 28(1):159-165. Epub 2010 Jun 22.
32. 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. Epub 2009 Oct 26.
33. Kenan Y., Kochba E., Shabar M., Gadasi H., Levin G., Foldes A.J., et al. Comparison of transdermal and subcutaneous teriparatide effect on markers of bone turnover and safety in postmenopausal women. Bone 2010, 47(Supplement 1):S49.
34. Stevenson C.L. Advances in peptide pharmaceuticals. Curr Pharm Biotechnol 2009, 10(1):122-137.