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Osteoporosis International
Published in: Osteoporosis International 10/2003

01-10-2003 | Original Article

Effect of raloxifene on bone mineral density and biochemical markers of bone turnover in Japanese postmenopausal women with osteoporosis: results from a randomized placebo-controlled trial

Authors: H. Morii, Y. Ohashi, Y. Taketani, M. Fukunaga, T. Nakamura, A. Itabashi, S. Sarkar, K. Harper

Published in: Osteoporosis International | Issue 10/2003

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Abstract

The safety and efficacy of raloxifene, a selective estrogen receptor modulator (SERM), has been studied extensively in large, global clinical trials. However, the effect of raloxifene on bone mineral density (BMD) and on biochemical markers of bone turnover in Japanese postmenopausal women with osteoporosis has not been rigorously evaluated. This study was designed to assess the safety and efficacy of raloxifene in Japanese postmenopausal women with osteoporosis following 1 year of therapy. Participants in this multicenter trial were randomly assigned to receive placebo, raloxifene 60 mg/day (RLX60), or raloxifene 120 mg/day (RLX120). Lumbar spine BMD was measured at baseline, 24, 40, and 52 weeks, and biochemical markers of bone turnover were assessed at baseline, 12, 24, and 52 weeks. Serum lipids were assessed at baseline, 12, 24, 40, and 52 weeks, and breast examinations and transvaginal ultrasound of the endometrium were performed at enrollment and 52 weeks. Compared with baseline, women taking RLX60 had significant increases in lumbar spine (L2-L4) BMD at 24 weeks (+3.3%, p<0.001) through 52 weeks (+3.5%, p<0.001) of therapy, and similar results were observed in the RLX120 group. Markers of bone turnover and total cholesterol and LDL-C were significantly reduced, and no significant treatment-group difference was observed for patients reporting at least one adverse event following randomization. In addition, there were no reported venous thromboembolic events (VTE) in any treatment group. The results of this study demonstrate that raloxifene is associated with early increases in lumbar spine BMD, has favorable effects on biochemical markers of bone turnover and lipid profile, and is well tolerated in postmenopausal Japanese women.
Literature
1.
Ettinger B, Black DM, Mitlak BH et al (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 282:637–645PubMed
2.
Johnston CC Jr, Bjarnason NH, Cohen FJ et al (2000) Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipipds in early postmenopausal women. 3-year data from two double-blind, randomized, placebo-controlled trials. Arch Intern Med 160:3444–3450CrossRefPubMed
3.
Delmas PD, Ensrud KE, Adachi JD et al (2002) Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial. J Clin Endocrinol Metab 87:3609–3617
4.
Walsh BW, Kuller LH, Wild RA et al (1998) Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women. JAMA 279:1445–1451PubMed
5.
Barrett-Connor E, Grady D, Sashegyi A et al (2002) Raloxifene and cardiovascular events in osteoporotic postmenopausal women: four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial. JAMA 287:847–857PubMed
6.
Cummings S, Eckert S, Krueger K et al (1999) The effect of raloxifene on risk of breast cancer in postmenopausal women. JAMA 281:2189–2197PubMed
7.
Cauley JA, Norton L, Lippman ME et al (2001) Continued breast cancer risk reduction in postmenopausal women treated with raloxifene: 4-year results from the MORE trial. Breast Cancer Res Treat 65:125–134CrossRefPubMed
8.
Cohen FJ, Watts S, Shah A et al (2000) Uterine effects of three-year raloxifene therapy in postmenopausal women younger than age 60. Obstet Gynecol 95:104–110CrossRefPubMed
9.
Lufkin EG, Wong M, Deal C (2001) The role of selective estrogen receptor modulators in the prevention and treatment of osteoporosis. Rheum Dis Clin North Am 27:163–185PubMed
10.
Maricic M, Adachi JD, Sarkar S et al (2002) Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis. Arch Intern Med 162:1140–1143CrossRefPubMed
11.
Cohen FJ, Lu Y (2000) Characterization of hot flashes reported by healthy postmenopausal women receiving raloxifene or placebo during osteoporosis prevention trials. Maturitas 34:65–73CrossRefPubMed
12.
Kanis JA, Melton LJ3, Christiansen C et al (1994) The diagnosis of osteoporosis. J Bone Miner Res 9:1137–1141PubMed
13.
Orimo H et al (1995) The criteria for the diagnosis of primary osteoporosis. The Examination Committee for the Criteria of Osteoporosis Diagnosis—the Japanese Society for Bone and Mineral Research. Osteoporos Int 3:111–116
14.
Lu Y, Ye K, Mathur AK et al (1997) Comparative calibration without a gold standard. Stat Med 16:1889–1905CrossRefPubMed
15.
Lu Y, Mathur AK, Blunt BA et al (1996) Dual X-ray absorptiometry quality control: comparison of visual examination and process-control charts. J Bone Miner Res 11:626–637PubMed
16.
Genant HK, Jergas M, Palermo L et al (1996) Comparison of semiquantitative visual and quantitative morphometric assessment of prevalent and incident vertebral fractures in osteoporosis. J Bone Miner Res 11:984–996PubMed
17.
Friedewald WT, Levy RI, Fredrickson DS (1972) Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 18(6):499–502PubMed
18.
Goldstein SR, Scheele WH, Rajagopalan SK et al (2000) A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium . Obstet Gynecol 95:95–103CrossRefPubMed
19.
Brown EG, Wood L, Wood S (1999) The medical dictionary for regulatory activities (MedDRA). Drug Saf 20:109–117PubMed
20.
Efron B, Stein C (1981) The jackknife estimate of variance. Ann Stat 9:586–596
21.
Sarkar S, Mitlak BH, Wong M et al (2002) Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res 17:1–10PubMed
22.
Delmas PD, Bjarnason NH, Mitlak BH et al (1997) Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 337:1641–1647PubMed
23.
Lips P, Duong T, Oleksik A et al (2001) A global study of vitamin D status and parathyroid function in postmenopausal women with osteoporosis: baseline data from the multiple outcomes of raloxifene evaluation clinical trial. J Clin Endocrinol Metab 86:1212–1221
Metadata
Title
Effect of raloxifene on bone mineral density and biochemical markers of bone turnover in Japanese postmenopausal women with osteoporosis: results from a randomized placebo-controlled trial
Authors
H. Morii
Y. Ohashi
Y. Taketani
M. Fukunaga
T. Nakamura
A. Itabashi
S. Sarkar
K. Harper
Publication date
01-10-2003
Publisher
Springer-Verlag
Published in
Osteoporosis International / Issue 10/2003
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-003-1424-1

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