Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2019
The risk of subsequent osteoporotic fractures is decreased in subjects experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies.
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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00523341 (An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab), which is not on this map. Cited by 19 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.
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials.BMJ (Clinical research ed.) · 2023Pooled it
- Executive summary: Italian guidelines for diagnosis, risk stratification, and care continuity of fragility fractures 2021.Frontiers in endocrinology · 2023Pooled it
- Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024Trial
- Romosozumab efficacy and safety in European patients enrolled in the FRAME trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022Trial
- Osteoporosis medication initiation after proximal humerus fractures is low, but associated with decreased secondary fragility fracture risk.OTA international : the open access journal of orthopaedic trauma · 2026Article
- Long-term effects of denosumab: a 10-year single-center retrospective study.Archives of osteoporosis · 2026Article
- Analysis of the efficacy and safety of denosumab in the treatment of patients with osteoporotic vertebral compression fractures after PVP.Scientific reports · 2025Article
- Review
- Beyond Bone Remodeling: Denosumab's Multisystemic Benefits in Musculoskeletal Health, Metabolism, and Age-Related Diseases-A Narrative Review.Biomedicines · 2025Review
- Goal-directed osteoporosis treatment: ASBMR/BHOF task force position statement 2024.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2024Article
- A Real-world Study of Denosumab For Reducing Refracture Risk after Percutaneous Vertebral Augmentation.Orthopaedic surgery · 2024Article
- Effect of Hyperprolactinemia on Bone Metabolism: Focusing on Osteopenia/Osteoporosis.International journal of molecular sciences · 2024Review
- Biologic Antiresorptive: Denosumab.Indian journal of orthopaedics · 2023Article
- Approach to the Patient With Bone Fracture: Making the First Fracture the Last.The Journal of clinical endocrinology and metabolism · 2023Article
- Osteoporosis Medications Prevent Subsequent Fracture in Frail Older Adults.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022Article
- Denosumab in the Treatment of Osteoporosis: 10 Years Later: A Narrative Review.Advances in therapy · 2022Review
- Should denosumab treatment for osteoporosis be continued indefinitely?Therapeutic advances in endocrinology and metabolism · 2021Review
- Effects of denosumab treatment in chronic liver disease patients with osteoporosis.World journal of gastroenterology · 2020Article
- A Review on the Role of Denosumab in Fracture Prevention.Drug design, development and therapy · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This post-hoc analysis queried whether women experiencing fracture on denosumab indicates inadequate treatment response or whether the risk of subsequent fracture remains low with continuing denosumab. Results showed that denosumab decreases the risk of subsequent fracture and fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response.
introductionThis analysis assessed whether a fracture sustained during denosumab therapy indicates inadequate treatment response and if the risk of a subsequent fracture decreases with continuing denosumab treatment.
methodsIn FREEDOM, a clinical trial to evaluate the efficacy and safety of denosumab, postmenopausal women with osteoporosis were randomized to placebo or denosumab for 3 years. In the 7-year FREEDOM Extension, all participants were allocated to receive denosumab. Here we compare subsequent osteoporotic fracture rates between denosumab-treated subjects during FREEDOM or the Extension and placebo-treated subjects in FREEDOM.
resultsDuring FREEDOM, 438 placebo- and 272 denosumab-treated subjects had an osteoporotic fracture. Exposure-adjusted subject incidence per 100 subject-years was lower for denosumab (6.7) vs placebo (10.1). Combining all subjects on denosumab from FREEDOM and the Extension for up to 10 years (combined denosumab), 794 (13.7%) had an osteoporotic fracture while on denosumab. Of these, one or more subsequent fractures occurred in 144 (18.1%) subjects, with an exposure-adjusted incidence of 5.8 per 100 subject-years, similar to FREEDOM denosumab (6.7 per 100 subject-years) and lower than FREEDOM placebo (10.1 per 100 subject-years). Adjusting for prior fracture, the risk of having a subsequent on-study osteoporotic fracture was lower in the combined denosumab group vs placebo (hazard ratio [95% CI]: 0.59 [0.43-0.81]; P = 0.0012).
conclusionsThese data demonstrate that denosumab decreases the risk of subsequent fracture and a fracture sustained while on denosumab is not necessarily indicative of inadequate treatment response.
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Registered trials
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