Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2012
Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study.
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, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 4 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 163 citations in OpenAlex.
- European guidance for the diagnosis and management of osteoporosis in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Guideline
- Efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: A systematic review and meta-analysis.Medicine · 2017Pooled it
- European guidance for the diagnosis and management of osteoporosis in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2013Guideline
- Bazedoxifene: a guide to its use in postmenopausal osteoporosis.Drugs & aging · 2012Guideline
- Bazedoxifene improves renal function and increases renal phosphate excretion in patients with postmenopausal osteoporosis.Journal of bone and mineral metabolism · 2020Trial
- The Effect of Abaloparatide-SC on Fracture Risk Is Independent of Baseline FRAX Fracture Probability: A Post Hoc Analysis of the ACTIVE Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2017Trial
- Preventive effects of raloxifene treatment on agerelated weight loss in postmenopausal women.Journal of bone and mineral metabolism · 2017Trial
- Bazedoxifene and Beyond: Identifying This SERM's Targets and Deciphering Its Molecular Mechanisms.Advances in pharmacological and pharmaceutical sciences · 2026Review
- Rethinking Osteoporosis Drugs: Can We Simultaneously Address Sarcopenia?International journal of molecular sciences · 2025Review
- Effect of Hyperprolactinemia on Bone Metabolism: Focusing on Osteopenia/Osteoporosis.International journal of molecular sciences · 2024Review
- Hormone therapy for sexual function in perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2023Review
- First Ecuadorian statement consensus for the evaluation and treatment of osteoporosis.Archives of osteoporosis · 2023Article
- Bone Turnover Markers: Basic Biology to Clinical Applications.Endocrine reviews · 2023Article
- A tissue-specific role of membrane-initiated ERα signaling for the effects of SERMs.The Journal of endocrinology · 2022Article
- Treatment of cystic fibrosis related bone disease.Journal of clinical & translational endocrinology · 2022Article
- Chronobiology and Chronotherapy of Osteoporosis.JBMR plus · 2021Review
- Joint position statement on management of patient with osteoporosis during COVID-19 contingency from the AMMOM, CONAMEGER, FELAEN, FEMECOG, FEMECOT, and ICAAFYD.Archives of osteoporosis · 2021Article
- Consensus statement on the use of HRT in postmenopausal women in the management of osteoporosis by SIE, SIOMMMS and SIGO.Journal of endocrinological investigation · 2019Article
- Repurposing the selective estrogen receptor modulatorEMBO molecular medicine · 2019Article
- Antiresorptive and anabolic agents in the prevention and reversal of bone fragility.Nature reviews. Rheumatology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledIn this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated.
introductionThis study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years.
methodsA total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N = 7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers.
resultsAt 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P < 0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n = 1,324; femoral neck T-score ≤-3.0 and/or ≥ 1 moderate or severe or ≥ 2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P = 0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P < 0.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P < 0.05) and was generally safe and well tolerated.
conclusionsThe findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.
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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.