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Review

Delivery of parathyroid hormone for the treatment of osteoporosis

Pages 993-1002 | Published online: 04 Nov 2005

Bibliography

  • DOBNIG H, TURNER RT: The effects of programmed administration of human parathyroid hormone fragment (1-34) on bone histomorphometry and serum chemistry in rats. Endocrinology (1997) 138(10:4607–4612.
  • ••Elegant demonstration of the requirementfor pulsatile PTH administration for anabolic activity.
  • LOTINUN S, SIBONGA JD, TURNER RT: Differential effects of intermittent and continuous administration of parathyroid hormone on bone histomorphometry and gene expression. Endocrine (2002) 17(1):29–36.
  • MORLEY P, WHITFIELD JF, WILLICK GE: Therapeutic prospects for parathyroid hormone and parathyroid hormone analogs. Curl: Med. Chem. Imm. Endocrinol Metab. Agents (2001) 1:269–287.
  • HODSMAN AB, FRAHER LJ, WATSON PH: Parathyroid hormone: the clinical experience and prospects. In: Anabolic Treatments for Osteoporosis. JF W P Morley (Eds), CRC Press, Boca Raton, FL, US (1998):83–108.
  • CRANDALL C: Parathyroid hormone for treatment of osteoporosis. Arch. Intern. Med. (2002) 162(11):2297–2309.
  • •Review of PTH clinical data.
  • JT JR, TREGEAR GW, KEUTMANN HT et al.: Synthesis of a biologically active N-terminal tetratriacontapeptide of parathyroid hormone. Proc. Nati Acad. Sci. USA (1971) 68(1):63–67.
  • ••Important demonstration of activity ofhPTH(1–34) fragment of hPTH(1–84).
  • BRIXEN KT, CHRISTENSEN PM, EJERSTED C, LANGDAHL BL: Teriparatide (biosynthetic human parathyroid hormone 1-34): a new paradigm in the treatment of osteoporosis. Basic Clip. Pharmacol Toxicol (2004) 94(6):260–270.
  • SIRIS E: Alendronate in the treatment of osteoporosis: a review of the clinical trials. Womens Health and. Based Med. (2000) 9(6):599–606.
  • ETTINGER B, BLACK DM, MITLAK BH et al.: Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA (1999) 282(7):637–645.
  • CHESNUT CH 3rd, SILVERMAN S ANDRIANO K et al.: A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am. J. Med. (2000) 109(4):267–276.
  • RIGGS BL, WAHNER HW, DUNN WL, MAZESS RB, OFFORD KP, MELTON LJ 3rd: Differential changes in bone mineral density of the appendicular and axial skeleton with aging: relationship to spinal osteoporosis. J. Clip. Invest. (1981) 67(2):328–335.
  • 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(19):1434–1441.
  • ••Publication of Forteo Phase III clinicaltrial data.
  • SCHWIETERT HR, GROEN EW, SOLLIE FA, JONKMAN JH: Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH(1-84)] in healthy postmenopausal volunteers. Clip. Pharmacol Ther. (1997) 61(3):360–376.
  • • PREOS P hase I clinical trial data.
  • HODSMAN AB, HANLEY DA, ETTINGER MP et al.: Efficacy and safety of human parathyroid hormone-(1-84) in increasing bone mineral density in postmenopausal osteoporosis. J. Clia Endocrinol Metab. (2003) 88(10:5212–5220.
  • •• PREOS P hase II clinical trial data.
  • WHITFIELD JF, MORLEY P, WILLICK G et al.: Cyclization by a specific lactam increases the ability of human parathyroid hormone (hPTH)-(1-31)NH2 to stimulate bone growth in ovariectomized rats. J. Bone Miner. Res. (1997) 12(8):1246–1252.
  • ••The first report of the activity ofOstabolin-C.
  • MOHAN S, KUTILEK S, ZHANG C et al: Comparison of bone formation responses to parathyroid hormone (1-34), (1-31), and (2-34) in mice. Bone (2000) 27(4):471–478.
  • •Demonstration of lack of hypercalcaemia inducing properties of hPTH(1–31) in mice.
  • FRAHER LJ, AVRAM R, WATSON PH et al.: Comparison of the biochemical responses to human parathyroid hormone-(1-31)NH2 and hPTH-(1-34) in healthy humans. J. Clip. Endocrinol Metab. (1999) 84(8):2739–2743.
  • •Report of lack of hypercalcaemia inducing activity of hPTH(1–31) in human study.
  • GOLD DT, SILVERMAN SL: Compliance with osteoporosis medications: challenges for healthcare providers. Medscape Ob/Cyn Womedi Health (2005) 10(1).
  • HODSMAN AB, FRAHER LJ, WATSON PH et al.: A randomized controlled trial to compare the efficacy of cyclical parathyroid hormone versus cyclical parathyroid hormone and sequential calcitonin to improve bone mass in postmenopausal women with osteoporosis. J. Clip. Endocrinol Metab. (1997) 82(2):620–628.
  • MIKI T, NAKATSUKA K, NAKA H 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.
  • •Study showing that daily PTH administration is not needed for bone anabolic responses.
  • HORWITZ MJ, TEDESCO MB, GUNDBERG C, GARCIA-OCANA A, STEWART AF: Short-term, high-dose parathyroid hormone-related protein as a skeletal anabolic agent for the treatment of postmenopausal osteoporosis. Endocrinol Metab. (2003) 88(2):569–575.
  • •Anabolic action of PTHrP in a human clinical trial.
  • MAHATO RI, NARANG AS, THOMA L, MILLER DD: Emerging trends in oral delivery of peptide and protein drugs. Grit. Rev Ther. Drug Carrier Syst. (2003) 20(2-3):153–214.
  • WOODLEY JF: Enzymatic barriers for GI peptide and protein delivery. Grit. Rev Ther. Drug Carrier Syst. (1994) 11(2-3):61–95.
  • GOLDBERG M, GOMEZ-ORELLANA I: Challenges for the oral delivery of macromolecules. Nat. Rev Drug Discov. (2003) 2(4):289–295.
  • •Overview of challenges to oral peptide delivery.
  • FRIEDMAN DI, ON GL: Oral absorption of peptides: influence of pH and inhibitors on the intestinal hydrolysis of leu-enkephalin and analogues. Pharm. Res. (1991) 8(1):93–96.
  • LANGGUTH P, BOHNER V, HEIZMANN J et al: The challenge of proteolytic enzymes in intestinal peptide delivery. J. Control. Release (1997) 46(1-2):39–57.
  • CHIN CM, GUTIERREZ M, STILL JG, KOSUTIC G: Pharmacokinetics of modified oral calcitonin product in healthy volunteers. Pharmacotherapy (2004) 24(8):994–1001.
  • News Release. Emisphere issues $10 million note to Novartis and enters into option and license agreement (2004).
  • LEONE-BAY A, SATO M, PATON D et al.: Oral delivery of biologically active parathyroid hormone. Pharm. Res. (2001) 18(7):964–970.
  • •Demonstration of the oral availability of hPTH (1–34).
  • COLE HW, ROWLEY E, SMITHS et al: Oral administration of recombinant human PTH (1-34) restores bone mass in osteopenic animals. J. Bone Miner. Res. (1999) 14:S167.
  • SARUBBI D, CAROZZA M, MAYER E, KUTZY T, GENOBLE L: Oral delivery of parathyroid hormone (1-38) in rats and primates. Pharm. Res. (1996) 13:S326.
  • GILLIGAN JP, WAGNER E, FLAZONE LM et al.: Oral delivery of salmon calcitonin in man: results of Phase I clinical studies demonstrating plasma calcitonin levels. Bone Miner. Res. (1996) 11:S20.
  • MEHTA N, STERN W, STURMER A, BOLAT A, CHEN J, GILLIGAN J: Oral delivery of PTH analogs by a solid dosage formulation. J. Bone Miner. Res. (2001) 16:S540.
  • FDA news, October 14 (2004).
  • •• Important report of the oral availability of PTH in humans.
  • BIRUDARAJ R, MAHALINGAM R, LI X, JASTI BR: Advances in buccal drug delivery. Grit. Rev Ther. Drug Carrier Syst (2005) 22(3):295–330.
  • •Thorough review of buccal delivery of peptides.
  • SENEL S, KREMER M, NAGY K, SQUIER C: Delivery of bioactive peptides and proteins across oral (buccal) mucosa. Curl: Pharm. Biotechnol (2001) 2(2):175–186.
  • CERNEA S, KIDRON M, WOHLGELERNTER J, MODI P, RAZ I: Dose-response relationship of oral insulin spray in healthy subjects. Diabetes Care (2005) 28(6):1353–1357.
  • XU HB, HUANG KX, ZHU YS et al: Hypoglycaemic effect of a novel insulin buccal formulation in rabbits. Pharmacol Res. (2002) 46(5):459–467.
  • HOSNY EA, ELKHESHEN SA, SALEH SI: Buccoadhesive tablets for insulin delivery: in-vitro and in-vivo studies. Chim. Far: (2002) 141(3):210–217.
  • SUZUKI Y, IGA K, YANAI S et al: Iontophoretic pulsatile transdermal delivery of human parathyroid hormone (1-34). Pharm. Pharmacol (2001) 53(9):1227–1234.
  • SUZUKI Y, NAGASE Y, IGA K et al.: Prevention of bone loss in ovariectomized rats by pulsatile transdermal iontophoretic administration of human PTH(1-34). Pharm. Li. (2002) 91(2):350–361.
  • MEDI BM, SINGH J: Electronically facilitated trasndermal delivery of human parathyroid hormone (1-34). Int. I Pharm. (2003) 263(1-2):25–33.
  • CHANG S- HOFMANN GA, ZHANG L, DEFTOS LJ, BANGA AK: The effect of electroporation on iontophoretic trasndermal delivery of calcium regulating hormones. J. Control. Release (2000) 66(2-3):127–133.
  • GOPALAKRISHNAN V, HWANG S, LOUGHREY H et al.: Administration of ThPTH to humans using Macroflux® transdermal technology results in the rapid delivery of biologically active PTH. J. Bone Mther. Res. (2004) 19( Suppl. 1):5460.
  • •Human transdermal delivery study of hPTH(1–34).
  • JOHNSON PH, QUAY SC: Advances in nasal drug delivery through tight junction technology. Expert Opin. Drug Deify. (2005) 2(2):281–298.
  • •Excellent review of challenges and opportunities of nasal peptide delivery.
  • TURKER S, ONUR E, OZER Y: Nasal route and drug delivery systems. Pharm. World Li. (2004) 26(3):137–142.
  • AGU RU, VALIVETI S, EARLES DC et al: Intranasal delivery of recombinant human parathyroid hormone [tiPTH (1-34)], teriparatide in rats. Endocr. Res. (2004) 30(3):455–467.
  • OHNUMA N: IBC's 2nd International Conference on Osteoporosis: Novel Therapeutic Developments. M G G K GR M D Thompson (Eds), International Business Communications, Southborough, MA, USA (1999).
  • MATSUMOTO T, SHIRAKI M, NAKAMURA T, HAGINO H, IINUMA H: Daily nasal spray of hPTH(1–34) for 3 months increases bone mass in osteoporotic subjects. J. Bone Miner. Res. (2004) 19\(Suppl. 1):544.
  • •Nasal PTH delivery in humans.
  • KARAPALIS AC: PTHrP: novel roles in skeletal biology. Curr Pharm Des (2001) 7(8):655–670.
  • CEFALU WT: Concept, strategies, and feasibility of non-invasive insulin delivery. Diabetes Care (2004) 27(1):239–246.
  • •Excellent overview of alternate delivery strategies for insulin.
  • OWENS DR, ZINMAN B, BOLLI G: Alternate routes of insulin delivery. Diabet. Med. (2003) 20(11):886–898.
  • •Excellent overview of alternate delivery options for insulin.
  • CLARK A: Formulation of proteins and peptides for inhalation. dds&s (2002) 2(3):73–77.
  • PATTON JS, TRINCHERO P, PLATZ RM: Bioavailability of pulmonary delivered peptides and proteins: a-interferon, calcitonins and parathyroid hormones. J. Control. Release (1994) 28(1-3):79–85.
  • CORKERY K: Inhalable drugs for systemic therapy. Respir. Care (2000) 45(7):831–835.
  • HUSSAIN A, ARNOLD JJ, KHAN MA, AHSAN F: Absorption enhancers in pulmonary protein delivery. I Control. Release (2004) 94(11):15–24.
  • SCHMEKEL B, BORGSTROM L, WOLLMER P: Difference in pulmonary absorption of inhaled terbutaline in healthy smokers and non-smokers. Thorax (1991) 46(4):225–228.
  • CODRONS V, VANDERBIST F, VERBEECK RK et al.: Systemic delivery of parathyroid hormone (1-34) using inhalation dry powders in rats. J. Pharm. Sci. (2003) 92(5):938–950.
  • WOLFF RK, ALLEN DL, HUGHES BL et al: The case for route-dependent toxicology comparisons: Using large animal models to speed clinical development of inhaled proteins. Respir. Drug Deify. (2000) 7:163–170.
  • PATTON JS: Pulmonary delivery of drugs for bone disorders. Adv. Drug Deify. Rev (2000) 42(3):239–248.
  • CODRONS V, VANDERBIST F, UCAKAR B, PREAT V, VANBEVER R: Impact of formulation and methods of pulmonary delivery on absorption of parathyroid hormone (1-34) from rat lungs. Pharin. Sci. (2004) 93(5):1241–1252.
  • PFUTZNER A, FLACKE F, POHL R et al.: Pilot study with technosphere/ PTH(1-34) — a new approach for effective pulmonary delivery of parathyroid hormone (1-34). Horin. Metab. Res. (2003) 35(5):319–323.
  • ••First reported inhaled PTH delivery studyIn humans.
  • GERBER RA, KOURIDES IA, CAPPELLERI JC et al.: Treatment satisfaction with inhaled insulin in patients with Type I diabetes. Diabetes Care (2001) 24(9):1556–1559.
  • BELMIN J, VALENSI P: Novel drug delivery systems for insulin, clinical potential for use in the elderly. Drugs Aging (2003) 20(4):303–312.
  • •Review of special challenges to alternate peptide delivery in elderly subjects.
  • STOEVER JA, PALMER JP: Inhaled insulin and insulin antibodies: a new twist to an old debate. Diabetes 7echnol. Ther. (2002) 4(2):157–161.
  • SHAPIRO DL, LIVINGSTON JN, MANISCALCO WM, FINKELSTEIN JN: Insulin receptors and insulin effects on Type II alveolar epithelial cells. Biochim. Biophys. Acta (1986) 885(2):216–220.
  • HASTINGS RH: Parathyroid hormone-related protein and lung biology. Respic Physiol Neurobiol (2004) 142(2-3):95–113.
  • •Report of PTHR1 receptors in the lung.

Websites

  • http://www.emisphere.com Emisphere Technologies, Inc. website.
  • http://www.bone-ltd.com Bone Medical website.
  • hdp://www.alteatherapeutics.com Altea Therapeutics website.

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