Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women
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A randomized trial was conducted in osteopenic postmenopausal women to compare the efficacy of tibolone versus raloxifene on BMD of the lumbar spine and hip. Tibolone increased lumbar spine and total hip BMD to a statistically significantly greater extent than raloxifene after two years of treatment.
Both tibolone, a selective tissue estrogenic activity regulator (STEAR), and raloxifene, a selective estrogen receptor modulator (SERM), are known to prevent postmenopausal bone loss. However, no head-to-head studies to compare the efficacy on bone have been performed.
A double-blind, randomized trial was conducted in osteopenic postmenopausal women aged 60–79 years to compare the effects of tibolone 1.25 mg/day to raloxifene 60 mg/day on bone mineral density (BMD). Serum osteocalcin and serum type I collagen C-telopeptides were measured as biochemical markers of bone metabolism.
Three hundred and eight subjects were allocated to treatment. Both treatments significantly increased lumbar spine BMD, however the increase was significantly larger after tibolone treatment than after raloxifene treatment (at year 1: 2.2% versus 1.2%, p < 0.01 and at year 2: 3.8% versus 2.1%, p < 0.001). After 2 years of treatment, the increase in total hip BMD in the tibolone group was significantly larger than in the raloxifene group (p < 0.05). Both treatments significantly reduced type I collagen C-telopeptides and osteocalcin levels when compared to baseline.
Tibolone 1.25 mg/day for 2 years prevents postmenopausal bone loss in older women and results in a larger increase of BMD both at the lumbar spine and hip than raloxifene.
KeywordsBone mineral density Menopause Osteoporosis Raloxifene Tibolone
The authors would like to thank Ellemiek von Mauw (Global Clinical Development, Organon, Oss) and Sabine Braat (Biometrics Department, Organon, Oss) for their contributions to the execution, statistical analysis and reporting of this study. The editorial contribution of Jane Irons (JSI Communications) to this manuscript is also acknowledged.
Conflicts of interest
P. Delmas has consulted for and received speaker fees from Organon. E. Nijland was an employee of Organon at the time of the study. S. Davis has been an investigator for Organon and has received honoraria for lectures from Organon. S. Adami and J. Hensen report no relevant conflicts of interest.
This study was funded by NV Organon, Oss, The Netherlands.
Tibolone (Livial®): NV Organon
Raloxifene (Evista®): Eli Lilly
- 1.European Foundation for Osteoporosis and the National Osteoporosis Foundation (1997) Consensus Development Statement: Who are candidates for prevention and treatment for osteoporosis? Osteoporos Int 7:1–6Google Scholar
- 5.Wells G, Tugwell P, Shea B et al, for the Osteoporosis Methodology Group and the Osteoporosis Research Advisory Group (2002) Meta-analyses of therapies for postmenopausal osteoporosis. V. Meta-analysis of the efficacy of hormone replacement therapy in treating and preventing osteoporosis in postmenopausal women. Endocr Rev 23:529–539PubMedCrossRefGoogle Scholar
- 10.Thiebaud D, Bigler JM, Renteria S et al. A 3-year study of prevention of postmenopausal bone loss: conjugated estrogens plus medroxyprogesterone acetate versus tibolone. Climacteric 1:202–210Google Scholar
- 24.Johnston CC Jr, Bjarnason NH, Cohen FJ et al (2000) Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: three-year data from 2 double-blind, randomized, placebo-controlled trials. Arch Intern Med 160:3444–3450PubMedCrossRefGoogle Scholar
- 26.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. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645PubMedCrossRefGoogle Scholar
- 27.Delmas PD, Ensrud KE, Adachi JD et al, for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators (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 87:3609–3617PubMedCrossRefGoogle Scholar
- 28.Cummings SR, Delmas PD, Bilezikian JP et al (2006) The effects of tibolone in older women with osteoporosis: preliminary results from the LIFT trial. Osteoporos Int 17:952–953Google Scholar