Effect of an intermittent weekly dose of human parathyroid hormone (1-34) on osteoporosis: A randomized double-masked prospective study using three dose levels

Osteoporosis International

Volumn 9, Issue 4, 1999, Pages 296-306

  Fujita, T ^a,j   Inoue, T ^b   Morii, H ^c   Morita, R ^d   Norimatsu, H ^e   Orimo, H ^f   Takahashi, H E ^g   Yamamoto, K ^h   Fukunaga, M ⁱ  

^a Calcium Research Institute   (Japan)

^b HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^c School of Medicine   (Japan)

^d SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^e KAGAWA UNIVERSITY   (Japan)

^f Tokyo Metropolitan Institute of Gerontology   (Japan)

^g NIIGATA UNIVERSITY   (Japan)

^h TOTTORI UNIVERSITY   (Japan)

ⁱ KAWASAKI MEDICAL SCHOOL   (Japan)

^j Calcium Research Institute   (Japan)

more..

Author keywords

Bone markers; Human parathyroid hormone (1 34); Lumbar bone mineral density; Osteoporosis

Indexed keywords

ALKALINE PHOSPHATASE BONE ISOENZYME; CALCITRIOL; CALCIUM; CREATININE; DEOXYPYRIDINOLINE; HYDROXYPROLINE; PARATHYROID HORMONE[1-34]; PHOSPHORUS; PYRIDINOLINE;

ADULT; AGED; ARTICLE; BONE DENSITY; BONE MINERAL; CALCIUM BLOOD LEVEL; CALCIUM URINE LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CREATININE URINE LEVEL; DOUBLE BLIND PROCEDURE; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; HUMAN; HYDROXYPROLINE URINE LEVEL; LUMBAR SPINE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OSTEOPOROSIS; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUBCUTANEOUS DRUG ADMINISTRATION;

AGED; AGED, 80 AND OVER; BIOLOGICAL MARKERS; BONE DENSITY; CALCITRIOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; TERIPARATIDE;

EID: 0032909761     PISSN: 0937941X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s001980050151     Document Type: Article

References (40)

1. Tam CS, Heersche JNM, Murray TM, Parsons JA. Parathyroid hormone stimulates the bone apposition rate independently of its resorptive action: differential effects of intermittent and continuous administration. Endocrinology 1982;110:506-12.
2. Malluche HH, Sherman D, Meyer W, Ritz E, Norman AW, Massry SG. Effects of long-term infusion of physiologic doses of 1-34 PTH on bone. Am J Physiol 1982;242:F197-201.
3. Morley P, Humziker J, Mecham M, Wronski TJ. Anabolic effect of parathyroid hormone on bone. Trends Endocrinol Metab 1997;8:225-31.
4. Reeve J, Williams D, Hesp R. Anabolic effect of low doses of a fragment of human parathyroid hormone on the skeleton in postmenopausal osteoporosis: report of a multicenter trial. BMJ 1980;280:1340-4.
5. Hesp R, Hulme P, Williams D, Reeve J. The relationship between changes in femoral bone density and calcium balance in patients with involutional osteoporosis treated with human parathyroid hormone fragment (hPTH 1-34). Metab Bone Dis Rel Res 1981;2:331-4.
6. Schwietert HR, Groen EWJ, Sollie FAE, Jonkman HG. Single dose subcutaneous administration of recombinant human parathyroid hormone hPTH(1-84) in healthy postmenopausal volunteers. Clin Pharmacol Ther 1997;61:360-76.
7. Hayashi Y, Yamamoto K, Fukunaga M, Ishibashi T, Takahashi K, Nishii Y. Assessment of bone mass by image analysis of metacarpal bone roentgenograms: a quantitative digital image processing (DIP) method. Radiation Med 1990;8:173-8.
8. Martin P, Bergmann P, Gillett C. Partially reversible osteopenia after surgery for primary hyperparathyroidism. Arch Intern Med 1986;146:689-91.
9. Silverberg SJ, Shane E, Delacruz L. Skeletal disease in primary hyperparathyroidism. J Bone Miner Res 1989;4:283-91.
10. Parfitt AM. Accelerated cortical bone loss: primary and secondary hyperparathysoidism. In: Uhton H, Stahl E, editors. Current concepts of bone fragility. Berlin Heidelberg New York: Springer, 1986:279-85.
11. Parisien M, Silverberg SJ, Shane E. The histomorphometry of bone in primary hyperparathyroidism: preservation of cancellous bone structure. J Clin Endocrinol Metab 1990;70:930-8.
12. Delling G. Bone Morphology in primary hyperparathyroidism: a qualitative and quantitative study of 391 cases. Appl Pathol 1987;55:147-59.
13. Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic action of parathyroid hormone on bone. Endocr Rev 1993;14:690-709.
14. Selye H. On the stimulation of new bone-formation with parathyroid extract and irradiated ergosterol. Endocrinology 1932;16:547-58.
15. Meng XW, Liang XG, Birchman R, Wu DD, Dempster DW, Lindsay R, Shen V. Temporal expression of the anabolic action of PTH in cancellous bone of ovariectomized rats. J Bone Miner Res 1996;11:421-9.
16. Mitlek BH, Burdette-Miller P, Schoenfeld D, Neer RM. Sequential effects of chronic human PTH 1-84 treatment of estrogen deficiency osteoporosis in the rat. J Bone Miner Res 1996;11:430-9.
17. Lane NE, Kimmel DB, Nilsson MHL, Cohen FE, Newton S, Nissenson RA, Strewler GJ. Bone-selective analogs of human PTH (1-34) increase bone formation in an ovariectomized rat model. J Bone Miner Res 1996;11:614-25.
18. 3 or resedronate on endosteal bone remodeling in canine cancellous and cortical bone. J Bone Miner Res 1996;11:600-13.
19. Miller SC, Hunziker J, Necham M, Wronski TJ. Intermittent parathyroid hormone administration stimulates bone formation in the mandible of aged ovariectomized rats. J Dent Res 1997; 76:1471-6.
20. Halloran BP, Bikle DD, Harris J, Tanner S, Curren T, Morey-Holton E. Regional responsiveness of the tibia to intermittent administration of parathyroid hormone as affected by skeletal unloading. J Bone Miner Res 1997;12:1068-74.
21. Sato M, Zeng G, Turner CH. Biosynthetic human parathyroid hormone 1-34 effects on bone quality in aged ovariectomized rats. Endocrinology 1997;138:4330-7.
22. Hilliker S, Wergedal JE, Gruber HE, Bettica P, Baylink DJ. Truncation of the amino terminus of PTH alters the anabolic activity on bone in vivo. Bone 1996;19:469-77.
23. Armamento-Villareal R, Ziambaras K, Abbasi-Jarhomi SH, Dimarogonas A, Halstead L, Fausto A, Avioli LV, Civitelli R. An intact N-terminus is required for the anabolic action of parathyroid hormone on adult female rats. J Bone Miner Res 1997;12:384-92.
24. Gunnes-Hey M, Hock JM. Increased trabecular bone mass in rats treated with synthetic human PTH. Metab Bone Dis Rel Res 1984;5:177-81.
25. Hori M, Uzawa T, Morita K. Effect of human parathyroid hormone (PTH 1-34) on experimental osteopenia of rats induced by ovariectomy. Bone Miner 1988;3:193-9.
26. Kalu DN. The ovariectomized rat model of postmenopausal bone loss. Bone Miner. 1991;15:175-92.
27. Frost HM, Jee WSS. On the rat model of human osteopenias and osteoporosis. Bone Miner 1992;18:227-36.
28. Reeve J, Arlot M, Price TR, Edouard C, Hesp R, Hulme P, et al. Periodic courses of human 1-34 parathyroid peptide alternating with calcitriol paradoxically reduce bone remodelling in spinal osteoporosis. Eur J Clin Invest 1987;17:421-8.
29. Reeve J, Meunier PJ, Parsons JA, Bernat M, Bijvoet OLM, Courpron P, et al. Anabolic effect of human parathyroid hormone fragment on trabecular bone in involutional osteoporosis: a multicentre trial. BMJ 1980;280:1340-4.
30. Reeve J, Arlot M, Bernat M, Charhon S, Edouard C, Slovik D, et al. Calcium-47 kinetic measurement of bone turnover compared to bone histomorphometry in osteoporosis: the influence of human parathyroid fragment (hPTH 1-34) therapy. Metab Bone Dis Rel Res 1981;3:23-30.
31. Reeve J, Arlot M, Bernat M, Edouard C, Hesp R, Slovik D, et al. Treatment of osteoporosis with human parathyroid hormone fragment 1-34: a positive final tissue balance in trabecular bone. Metab Bone Dis Rel Res (Suppl) 1980;2:355-60.
32. Lindsay R, Nieves J, Formica C, Henneman E, Woelfert L, Shen V, et al. Randomized controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis. Lancet 1997;350:550-5.
33. Reeve J, Bradbeer JN, Arlot M, Davies UM, Green JR, Hampton L, et al. hPTH 1-34 treatment of osteoporosis with added hormone replacement therapy: biochemical, kinetic and histolo-gical responses. Osteopor Int 1991;1:162-170.
34. Bradbeer JN, Arlot ME, Meunier PJ, Reeve J. Treatment of osteoporosis with parathyroid peptide (hPTH 1-34) and oestrogen: increase in volumetric density of iliac cancellous bone may depend on reduced trabecular spacing as well as increased thickness of packets of newly formed bone. Clin Endocrinol 1992;37:282-9.
35. Reeve J, Arlot ME, Bradbeer JN, Hesp R, McAlly E, Meunier PJ, Zanelli JM. Human parathyroid peptide treatment of vertebral osteoporosis. Osteoporos Int 1993;1(Suppl):S199-203.
36. Slovik DM, Rosenthal DI, Doppelt SH, Potts JT Jr, Daly MA, Campbell JA, Neer RM. Restoration of spinal bone in osteoporotic men by treatment with human parathyroid hormone (1-34) and 1,25-dihydroxy vitamin D. J Bone Miner Res 1986;1:377-81.
37. Neer RM, Slovik D, Doppelt S, Daly M, Rosenthal D, Lo C, Potts J. The use of parathyroid hormone plus 1,25-dihydroxyvitamin D to increase trabecular bone in osteoporotic men and postmenopausal women. In: Christiansen C, Johansen JS, Riis BJ, editors. Osteoporosis 1987. Copenhagen: Osteopress, 1987:829-35.
38. Neer M, Slovik DM, Daly M, Potts T Jr, Nussbaum SR. Treatment of postmenopausal osteoporosis with daily parathyroid hormone plus calcitriol. Osteoporos Int 1993;1(Suppl):S204-5.
39. Hesch RD, Busch U, Prokop M, Delling G, Rittinghaus EF. Increase of vertebral density by combination therapy with pulsatile 1-38 hPTH and sequential addition of calcitonin nasal spray in osteoporotic patients. Calcif Tissue Int 1989;44:176-80.
40. Hodsman AB, Fohr LT, Watson PH, Ostbye T, Stitt LW, Adachi O, et al. A randomized controlled trial to compare the efficacy of cyclical parathyroid hormone versus cyclic parathyroid hormone and sequential calcitonin to improve bone mass in postmenopausal women with osteoporosis. J Clin Endocrinol Metab 1997;82:620-8.