A controlled trial of raloxifene (LY139481) HCl: Impact on bone turnover and serum lipid profile in healthy postmenopausal women

Journal of Bone and Mineral Research

Volumn 11, Issue 6, 1996, Pages 835-842

  Draper, Michael W ^a   Flowers, David E ^b   Huster, William J ^a   Neild, Julie A ^a   Harper, Kristine D ^c   Arnaud, Claude ^d  

^a ELI LILLY AND COMPANY   (United States)

^b MedE America   (United States)

^c Center for Bone Diseases   (United States)

^d Prog in Osteoporosis and Bone Biol   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; CHOLESTEROL; CONJUGATED ESTROGEN; LIPID; MEDROXYPROGESTERONE ACETATE; OSTEOCALCIN; RALOXIFENE;

ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; BONE TURNOVER; CALCIUM EXCRETION; CALCIUM URINE LEVEL; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ENDOMETRIUM; ENDOMETRIUM BIOPSY; ESTROGEN THERAPY; FEMALE; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; LIPID BLOOD LEVEL; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; VASODILATATION;

EID: 0030015080     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbmr.5650110615     Document Type: Article

References (41)

1. American College of Physicians 1992 Guidelines for counseling postmenopausal women about preventive hormone therapy. Ann Intern Med 12:1038-1041.
2. Greendale GA, Judd HL 1993 The menopause: Health implications and clinical management. J Am Geriatr Soc 41:426-436.
3. Lomax L, Schönbaum E 1993 Postmenopausal hot flushes and their management. Pharmacol Ther 57:347-358.
4. Grady D, Rubin SM, Petitti DB, Fox CS, Black D, Ettinger B, Ernster VL, Cummings S 1992 Hormone therapy to prevent disease and prolong life in postmenopausal women. Ann Intern Med 117:1016-1037.
5. Lindsay R 1993 Hormone replacement therapy for prevention and treatment of osteoporosis. Am J Med 95 (Suppl 5A):37-39 (abstract).
6. Field CS, Ory SJ, Wahner HW, Herrmann RR, Judd HL, Riggs BL 1993 Preventive effects of transdermal 17β-estradiol on osteoporotic changes after surgical menopause: A two-year placebo-controlled trial. Am J Obstet Gynecol 168:114-121.
7. Harris ST, Genant HK, Baylink DJ, Gallagher C, Karp SH, McConnell MA, Green EM, Stoll RW 1991 The effects of estrone (Ogen) on spinal bone density of postmenopausal women. Arch Intern Med 151:1980-1984.
8. Stampfer MJ, Colditz GA, Willett WC, Manson JE, Rosner B, Speizer FE, Hennekens CH 1991 Postmenopausal estrogen therapy and cardiovascular disease. New Engl J Med 325:756-762.
9. Lobo RA 1991 Clinical Review 27. Effects of hormonal replacement on lipids and lipoproteins in postmenopausal women. J Clin Endocrinol Metab 73:925-930.
10. Barrett-Connor E, Buch TL 1991 Estrogen and coronary heart disease in women. JAMA 265:1861-1867.
11. Jones CD, Jevnikar MG, Pike AJ, Peters MK, Black LJ, Thompson AR, Falcone JF, Clemens JA 1984 Antiestrogens. 2. structure-activity studies in a series of 3-aroyl-2-arylbenzo-[b]thiophene derivatives leading to [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl][4-[2-(1-piperidinyl)ethoxy]- phenyl] methanone hydrochloride (LY156758), a remarkably effective estrogen antagonist with only minimal intrinsic estrogenicity. J Med Chem 27:1057-1066.
12. Draper MW, Flowers DE, Neild JA, Huster WJ, Zerbe RL 1995 Antiestrogenic properties of raloxifene. Pharmacology 50:209-217.
13. Black LJ, Jones CD, Falcone JF 1983 Antagonism of estrogen action with a new benzothiophene derived antiestrogen. Life Sci 32:1031-1036.
14. Miller MA, Katzenellenbogen BS 1983 Characterization and quantitation of antiestrogen binding sites in estrogen receptor-positive and -negative human breast cancer cell lines. Cancer Res 43:3094-3100.
15. Black LJ, Sato M, Rowley ER, Magee DE, Dekele A, Williams DC, Cullinan GJ, Bendele R, Kauffman RF, Bensch WR, Frolik CA, Termine JD, Bryant HU 1994 Raloxifene (LY 139481 HCl) prevents bone loss and reduces serum cholesterol without causing uterine hypertrophy in ovariectomized rats. J Clin Invest 93:63-69.
16. Draper MW, Flowers DE, Huster WJ, Neild JA 1993 Effects of raloxifene (LY139481 HCl) on biochemical markers of bone and lipid metabolism in healthy postmenopausal women. In: Christiansen C, Riis B (eds.) Proceedings 1993, Fourth International Symposium on Osteoporosis and Consensus Development Conference. Aalborg, Denmark: Handelstrykkeriet Aalborg ApS, pp. 119-121. The principal investigators participating in this study are acknowledged in this Proceedings.
17. Stock JL, Coderre JA, Mallette LE 1985 Effects of a short course of estrogen on mineral metabolism in postmenopausal women. J Clin Endocrinol Metab 61:595-600.
18. Hill CS, Wolfert RL 1989 The preparation of monoclonal antibodies which react preferentially with human bone alkaline phosphatase and not liver alkaline phosphatase. Clin Chim Acta 186:315-320.
19. Gundberg CM, Wilson PS, Gallop PM, Parfitt AM 1985 Determination of osteocalcin in human serum: Results with two kits compared with those by a well-characterized assay. Clin Chem 31:1720-1723.
20. Eastell R, Hampton L, Colwell A 1990 Urinary collagen crosslinks are highly correlated with radioisotopic measurements of bone resorption. Presented at the Third International Symposium on Osteoporosis. Copenhagen, Denmark, October 1990.
21. Tietz NW 1983 Clinical Guide to Laboratory Tests. W.B. Saunders, Philadelphia, Pennsylvania, U.S.A. pp. 152-154.
22. Baginski ES, Marie SS, Clark WL, Zak B 1973 Direct microdetermination of serum calcium. Clin Chim Acta 46:46-54.
23. Palmerini CA, Fini C, Floridi A, Morelli A, Vedovelli A 1985 High-performance liquid chromatography analysis of free hydroxyproline and proline in blood plasma and of free and peptide-bound hydroxyproline in urine. J Chromatog 339:285-292.
24. Yaegaki K, Tonzetich J, Ng ASK 1986 Improved high-performance liquid chromatography method for quantitation of proline and hydroxyproline in biological materials. J Chromatog 356:163-170.
25. Friedewald WT, Levy RI, Fredrickson DS 1972 Estimation of the concentration of low-density lipoprotein cholesterol in plasma without the use of preparative ultracentrifuge. Clin Chem 18:499-502.
26. 2+ precipitation procedure for quantitation of high-density lipoprotein cholesterol. Clin Chem 28:1379-1388.
27. Giant M, Eisenhut C, Boss S, Draper M 1995 A scale for assessing postmenopausal endometrial proliferation in response to potential or known selective estrogen respecter modulators. Am J Clin Path 104:341-342.
28. D'Agostino RB, Massaro J, Kwan H, Cabral H 1993 Strategies for dealing with multiple treatment comparisons in confirmatory clinical trials. Drug Info J 27:625-641.
29. Delmas PD 1993 Biochemical markers of bone turnover for the clinical investigation of osteoporosis. Osteoporos Int 3:81-86.
30. Eastell R, Robins SP, Colwell T, Assiri AMA, Riggs BL, Russell RGG 1993 Evaluation of bone turnover in type-I osteoporosis using biochemical markers specific for both boneformation and bone-resorption. Osteoporos Int 3:255-260.
31. Risteli L, Risteli J 1993 Biochemical markers of bone metabolism. Ann Med 25:385-393.
32. Grey AB, Stapleton JP, Evans MC, Reid IR 1995 The effect of the anti-estrogen tamoxifen on cardiovascular risk factors in normal postmenopausal women. J Clin Endo Metab 80:3191-3195.
33. Love RR, Wiebe DA, Newcomb PA, Cameron L, Leventhal H, Jordan VC, Feyzi J, DeMets DL 1991 Effects of tamoxifen on cardiovascular risk factors in postmenopausal women. Ann Intern Med 115:860-864.
34. Love RR, Mazess RB, Barden HS, Epstein S, Newcomb PA, Jordan VC, Carbone PP, DeMets DL 1992 Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer. New Engl J Med 326:852-856.
35. Fornander T, Cedermark B, Mattsson A, Skoog L, Theve T, Askergren J, Rutqvist LE, Glas U, Silfverswärd C, Somell A, Wilking N, Hjalmar M-L 1989 Adjuvant tamoxifen in early breast cancer: Occurrence of new primary cancers. Lancet 1:117-120.
36. Draper MW, Boss SM, Huster WJ, Neild JA 1994 Effects of raloxifene hydrochloride on serum markers of bone and lipid metabolism - Dose-response relationships. Calcif Tissue Int 54:339 (abstract).
37. Lufkin EG, Wahner HW, O'Fallon WM, Hodgson SF, Kotowicz MA, Lane AW, Judd HL, Caplan RH, Riggs BL 1992 Treatment of postmenopausal osteoporosis with transdermal estrogen. Ann Intern Med 117:1-9.
38. Weiss NS, Ure CL, Ballard JH, Williams AR, Daling JR 1980 Decreased risk of fractures of the hip and lower forearm with postmenopausal use of estrogen. New Engl J Med 303:1195-1198.
39. Genant HK, Cann CE, Ettinger B, Gordan GS 1982 Quantitative Computed Tomography of Vertebral Spongiosa: A sensitive method for detecting early bone loss after oophorectomy. Ann Intern Med 97:699-705.
40. Ettinger B, Genant HK, Cann CE 1985 Long-term estrogen replacement therapy prevents bone loss and fractures. Ann Intern Med 102:219-324.
41. Lindsay R, Aitken JM, Anderson JB, Hart DM, MacDonald EB, Clarke AC 1976 Long-term prevention of postmenopausal osteoporosis by estrogen. Lancet 1:1038-1041.