Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2015
The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension 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, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 4 of them syntheses that pooled it.
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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.
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Who cites it
112 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Treatment for osteoporosis in people with beta-thalassaemia.The Cochrane database of systematic reviews · 2023Pooled it
- Effect of drugs on bone mineral density in postmenopausal osteoporosis: a Bayesian network meta-analysis.Journal of orthopaedic surgery and research · 2021Pooled it
- Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis.Clinical rheumatology · 2020Pooled it
- Fracture risk following intermission of osteoporosis therapy.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Pooled it
- Probability of achieving bone mineral density treatment goals with denosumab treatment in postmenopausal women with osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Trial
- One versus 2 years of alendronate following denosumab: the CARD extension.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024Trial
- RANKL blockade for erosive hand osteoarthritis: a randomized placebo-controlled phase 2a trial.Nature medicine · 2024Trial
- Assessing the effects of long-term osteoporosis treatment by using conventional spine radiographs: results from a pilot study in a sub-cohort of a large randomized controlled trial.Skeletal radiology · 2019Trial
- Relationship Between Bone Mineral Density T-Score and Nonvertebral Fracture Risk Over 10 Years of Denosumab Treatment.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2019Trial
- The risk of subsequent osteoporotic fractures is decreased in subjects experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019Trial
- Denosumab in transfusion-dependent thalassemia osteoporosis: a randomized, placebo-controlled, double-blind phase 2b clinical trial.Blood advances · 2018Trial
- Effects of Long-Term Denosumab on Bone Histomorphometry and Mineralization in Women With Postmenopausal Osteoporosis.The Journal of clinical endocrinology and metabolism · 2018Trial
- Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium.Archives of osteoporosis · 2017Trial
- Influence of subject discontinuation on long-term nonvertebral fracture rate in the denosumab FREEDOM Extension study.BMC musculoskeletal disorders · 2017Trial
- Differential Effects of Teriparatide and Denosumab on Intact PTH and Bone Formation Indices: AVA Osteoporosis Study.The Journal of clinical endocrinology and metabolism · 2016Trial
- Long-term effects of denosumab: a 10-year single-center retrospective study.Archives of osteoporosis · 2026Article
- Hypocalcemia following denosumab in osteoporosis: Incidence and risk factors in a Saudi cohort.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
- Biologics for bone regeneration: advances in cell, protein, gene, and mRNA therapies.Bone research · 2026Review
- Article
- Effect of denosumab combination with proximal femoral nail antirotation surgery in elderly patients with intertrochanteric femoral fractures: A comparative study.Bone reports · 2025Article
52 more citing papers are in PubMed but not listed here.
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThe FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis. Treatment for up to 8 years was associated with persistent reduction of bone turnover, continued increases in bone mineral density, low fracture incidence, and a favorable benefit/risk profile.
introductionThis study aims to report the results through year 5 of the FREEDOM Extension study, representing up to 8 years of continued denosumab treatment in postmenopausal women with osteoporosis.
methodsWomen who completed the 3-year FREEDOM study were eligible to enter the 7-year open-label FREEDOM Extension in which all participants are scheduled to receive denosumab, since placebo assignment was discontinued for ethical reasons. A total of 4550 women enrolled in the Extension (2343 long-term; 2207 cross-over). In this analysis, women in the long-term and cross-over groups received denosumab for up to 8 and 5 years, respectively.
resultsThroughout the Extension, sustained reduction of bone turnover markers (BTMs) was observed in both groups. In the long-term group, mean bone mineral density (BMD) continued to increase significantly at each time point measured, for cumulative 8-year gains of 18.4 and 8.3 % at the lumbar spine and total hip, respectively. In the cross-over group, mean BMD increased significantly from the Extension baseline for 5-year cumulative gains of 13.1 and 6.2 % at the lumbar spine and total hip, respectively. The yearly incidence of new vertebral and nonvertebral fractures remained low in both groups. The incidence of adverse and serious adverse events did not increase over time. Through Extension year 5, eight events of osteonecrosis of the jaw and two events of atypical femoral fracture were confirmed.
conclusionsDenosumab treatment for up to 8 years was associated with persistent reductions of BTMs, continued BMD gains, low fracture incidence, and a consistent safety profile.
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