Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2008
Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00431431 (A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone (1.25 mg Org OD 14) and Raloxifene (60 mg) on Bone Mineral Density in Osteopenic Postmenopausal Women
Who cites it
15 citing papers in PubMed, 46 citations in OpenAlex.
- The 2025 Menopausal Hormone Therapy Guidelines - Korean Society of Menopause.Journal of menopausal medicine · 2025Review
- Article
- Repurposing of Tibolone in Alzheimer's Disease.Biomolecules · 2023Review
- Treating menopause - MHT and beyond.Nature reviews. Endocrinology · 2022Review
- The Effects of Osteoporotic and Non-osteoporotic Medications on Fracture Risk and Bone Mineral Density.Drugs · 2021Review
- The 2020 Menopausal Hormone Therapy Guidelines.Journal of menopausal medicine · 2020Review
- The estrogen receptor 1 gene affects bone mineral density and osteoporosis treatment efficiency in Slovak postmenopausal women.BMC medical genetics · 2018Article
- Tissue selective estrogen complex (TSEC): a review.Menopause (New York, N.Y.) · 2018Review
- Elevated Bone Turnover Markers after Risk-Reducing Salpingo-Oophorectomy in Women at Increased Risk for Breast and Ovarian Cancer.PloS one · 2017Article
- Distribution of serum βCTX in a population-based study of postmenopausal women taking into account different anti-osteoporotic therapies (the FRODOS Cohort).Journal of bone and mineral metabolism · 2013Article
- Updated clinical recommendations for the use of tibolone in Asian women.Climacteric : the journal of the International Menopause Society · 2010Review
- Prevalent and Emerging Therapies for Osteoporosis.Medical journal, Armed Forces India · 2010Article
- Postmenopausal hormone therapy: an Endocrine Society scientific statement.The Journal of clinical endocrinology and metabolism · 2010Review
- Effects of raloxifene and estradiol on bone turnover parameters in intact and ovariectomized rats.Journal of physiology and biochemistry · 2010Article
- Bone physiology, disease and treatment: towards disease system analysis in osteoporosis.Clinical pharmacokinetics · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledA 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.
introductionBoth 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.
methodsA 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.
resultsThree 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.
conclusionsTibolone 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.