Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2022
Romosozumab efficacy and safety in European patients enrolled in the FRAME 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01575834 (A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis), which is not on this map. Cited by 7 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.
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Who cites it
7 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Romosozumab's Effect on Bone Mineral Density in Patients with Osteoporosis: A Systematic Review and Meta-Analysis.Current medicinal chemistry · 2026Pooled it
- Effects of anti-osteoporotic drugs in patients with chronic kidney disease: a systemic review and network meta-analysis of bone mineral density, clinical fracture rate and renal function.Frontiers in pharmacology · 2025Pooled it
- Assessment of the efficacy and safety of anti-sclerostin antibody therapy for osteoporosis in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2025Pooled it
- Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials.Journal of bone and mineral metabolism · 2024Pooled it
- Monthly treatment with romosozumab for 1 year increases bone mineral at the hip, but not the knee, in women with chronic spinal cord injury.JBMR plus · 2024Trial
- Osteoporosis: The Renascent Impact of Vertebral Fractures-A Narrative Review of Diagnosis, Risk Stratification, and Integrated Management.Journal of clinical medicine · 2026Review
- Treatment patterns of romosozumab in postmenopausal women with severe osteoporosis in Denmark: findings from the ROmosozumab in Scandinavia real-world Evidence Study (ROSES).Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density.
introductionIn the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world. This post hoc analysis assessed romosozumab efficacy and safety in European patients enrolled in the FRAME trial and extension study.
methodsIn FRAME (NCT01575834), patients were randomised 1:1 to romosozumab 210 mg or placebo monthly (QM) for 12 months, followed by open-label denosumab 60 mg Q6M to month 36, including a 12-month extension study. We report incidence of major fracture outcomes, bone mineral density (BMD) change from baseline and safety for European patients enrolled in FRAME.
resultsIn FRAME, 3013/7180 (41.96%) patients were European; 1494 received romosozumab and 1519 received placebo. Through 12 months, romosozumab reduced fracture risk versus placebo for non-vertebral fracture (1.4% versus 3.0%; p = 0.004), clinical fracture (1.4% versus 3.6%; p < 0.001), new vertebral fracture (0.4% versus 2.1%; p < 0.001) and major osteoporotic fracture (0.9% versus 2.8%; p < 0.001), with results sustained through 36 months following transition to denosumab. Hip fractures were numerically reduced with romosozumab at month 12 (0.2% versus 0.6%; p = 0.092). Romosozumab increased BMD versus placebo at month 12; all patients in the romosozumab and placebo groups experienced further increases by month 36 after transition to denosumab. Adverse events were balanced between groups.
conclusionsAmong European patients in FRAME, romosozumab resulted in early and sustained risk reduction for all major fracture categories, associated with large BMD gains that continued after transition to denosumab.
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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.