Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2013
Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial.
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, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 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
53 citing papers in PubMed, 2 syntheses or guidelines pooled 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
- Safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density: a meta-analysis.International journal of clinical and experimental pathology · 2014Pooled it
- Trial
- Further reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip bone mineral density after 3 years.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015Trial
- The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015Trial
- Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2014Trial
- The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension.The Journal of clinical endocrinology and metabolism · 2013Trial
- Long-term effects of denosumab: a 10-year single-center retrospective study.Archives of osteoporosis · 2026Article
- Biochemical bone biomarkers in plasma cell dyscrasias.British journal of haematology · 2026Review
- Comparative safety of denosumab and romosozumab in osteoporosis: an analysis based on the FDA adverse event reporting system database.Frontiers in medicine · 2026Article
- Safety and efficacy of sequential treatments for postmenopausal osteoporosis: a network meta-analysis of randomised controlled trials.EClinicalMedicine · 2024Article
- Research trends and hotspots on osteoporosis: a decade-long bibliometric and visualization analysis from 2014 to 2023.Frontiers in medicine · 2024Article
- Risk comparison of osteonecrosis of the jaw in osteoporotic patients treated with bisphosphonates vs. denosumab: a multi-institutional retrospective cohort study in Taiwan.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023Article
- Irisin Protects against Loss of Trabecular Bone Mass and Strength in Adult Ovariectomized Mice by Stimulating Osteoblast Activity.International journal of molecular sciences · 2023Article
- Risk factors for poor response to denosumab treatment in Japanese postmenopausal women with osteoporosis.Journal of bone and mineral metabolism · 2022Observational
- Effect of the duration of previous osteoporosis treatment on the effect of romosozumab treatment.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022Article
- Alkaline Phosphatase: An Old Friend as Treatment Target for Cardiovascular and Mineral Bone Disorders in Chronic Kidney Disease.Nutrients · 2022Review
- On the effect of antiresorptive drugs on the bone remodeling of the mandible after dental implantation: a mathematical model.Scientific reports · 2021Article
- RANKL as a target for the treatment of osteoporosis.Journal of bone and mineral metabolism · 2021Review
- Comparison of the Effects of Native Vitamin D and Eldecalcitol on Muscular Strength and Dynamic Balance in Patients with Postmenopausal Osteoporosis.Progress in rehabilitation medicine · 2020Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledIn a phase 2 study, continued denosumab treatment for up to 8 years was associated with continued gains in bone mineral density and persistent reductions in bone turnover markers. Denosumab treatment was well tolerated throughout the 8-year study.
introductionThe purpose of this study is to present the effects of 8 years of continued denosumab treatment on bone mineral density (BMD) and bone turnover markers (BTM) from a phase 2 study.
methodsIn the 4-year parent study, postmenopausal women with low BMD were randomized to receive placebo, alendronate, or denosumab. After 2 years, subjects were reallocated to continue, discontinue, or discontinue and reinitiate denosumab; discontinue alendronate; or maintain placebo for two more years. The parent study was then extended for 4 years where all subjects received denosumab.
resultsOf the 262 subjects who completed the parent study, 200 enrolled in the extension, and of these, 138 completed the extension. For the subjects who received 8 years of continued denosumab treatment, BMD at the lumbar spine (N = 88) and total hip (N = 87) increased by 16.5 and 6.8 %, respectively, compared with their parent study baseline, and by 5.7 and 1.8 %, respectively, compared with their extension study baseline. For the 12 subjects in the original placebo group, 4 years of denosumab resulted in BMD gains comparable with those observed during the 4 years of denosumab in the parent study. Reductions in BTM were sustained over the course of continued denosumab treatment. Reductions also were observed when the placebo group transitioned to denosumab. Adverse event profile was consistent with previous reports and an aging cohort.
conclusionContinued denosumab treatment for 8 years was associated with progressive gains in BMD, persistent reductions in BTM, and was well tolerated.
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