Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2014
Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00330759 (A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid), which is not on this map. Cited by 94 papers, 15 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.
Who cites it
94 citing papers in PubMed, 15 syntheses or guidelines pooled it, 182 citations in OpenAlex.
- Comparison of denosumab and oral bisphosphonates for the treatment of glucocorticoid-induced osteoporosis: a systematic review and meta-analysis.BMC musculoskeletal disorders · 2022Pooled it
- Comparison of denosumab and zoledronic acid for the treatment of solid tumors and multiple myeloma with bone metastasis: a systematic review and meta-analysis based on randomized controlled trials.Journal of orthopaedic surgery and research · 2021Pooled it
- Differences between bisphosphonate-related and denosumab-related osteonecrosis of the jaws: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Pooled it
- Meta-analysis of clinical trials to assess denosumab over zoledronic acid in bone metastasis.International journal of clinical pharmacy · 2021Pooled it
- Do Bisphosphonates Alleviate Pain in Children? A Systematic Review.Current osteoporosis reports · 2020Pooled it
- Bisphosphonates Versus Denosumab for Prevention of Pathological Fracture in Advanced Cancers With Bone Metastasis: A Meta-analysis of Randomized Controlled Trials.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2020Pooled it
- Medication-related osteonecrosis of the jaws (MRONJ) in cancer patients treated with denosumab VS. zoledronic acid: A systematic review and meta-analysis.Medicina oral, patologia oral y cirugia bucal · 2020Pooled it
- Non-Radiation Based Early Pain Relief Treatment Options for Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain: A Systematic Review.Frontiers in oncology · 2020Pooled it
- Atypical femoral fracture in patients with bone metastasis receiving denosumab therapy: a retrospective study and systematic review.BMC cancer · 2019Pooled it
- Denosumab versus bisphosphonates for the treatment of bone metastases from solid tumors: a systematic review.The European journal of health economics : HEPAC : health economics in prevention and care · 2019Pooled it
- Denosumab versus bisphosphonates in patients with advanced cancers-related bone metastasis: systematic review and meta-analysis of randomized controlled trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Pooled it
- Bisphosphonates in multiple myeloma: an updated network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- SEOM Clinical Guideline for bone metastases from solid tumours (2016).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016Guideline
- The effects of lung and prostate cancer bone metastasis on serum osteoprotegerin levels: a meta-analysis.Scientific reports · 2015Pooled it
- Systematic literature review and network meta-analysis comparing bone-targeted agents for the prevention of skeletal-related events in cancer patients with bone metastasis.The oncologist · 2015Pooled it
- Trial
- Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study.Blood advances · 2021Trial
- Pain and analgesic use associated with skeletal-related events in patients with advanced cancer and bone metastases.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Trial
- Denosumab for the prevention of skeletal complications in metastatic castration-resistant prostate cancer: comparison of skeletal-related events and symptomatic skeletal events.Annals of oncology : official journal of the European Society for Medical Oncology · 2015Trial
- Timing of bone-modifying agent initiation and skeletal-related event risk in patients with bone metastases from solid tumors: a retrospective landmark and propensity score-matched analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
34 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
13 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeBone complications of metastatic disease, including skeletal-related events (SREs), impair patients' functioning and quality of life. In a randomized, phase 3 trial of 1,776 patients with metastases from solid tumors (except breast or prostate) or multiple myeloma, denosumab was non-inferior to zoledronic acid (ZA) in delaying or preventing SREs. This ad hoc analysis reports outcomes in the subgroup of 1,597 patients with solid tumors, excluding patients with multiple myeloma.
methodsPatients received monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg, adjusted for creatinine clearance, with calcium and vitamin D supplementation recommended. Endpoints included times to first on-study SRE, first-and-subsequent SREs, and pain worsening.
resultsDenosumab significantly delayed time to first on-study SRE compared with ZA (HR, 0.81; 95 % CI, 0.68-0.96) and time to first-and-subsequent SREs (RR, 0.85; 95 % CI, 0.72-1.00). Denosumab also significantly delayed time to development of moderate or severe pain (HR, 0.81; 95 % CI, 0.66-1.00), pain worsening (HR, 0.83; 95 % CI, 0.71-0.97), and worsening pain interference in patients with no/mild baseline pain (HR, 0.77; 95 % CI, 0.61-0.96). Adverse event rates were 96 % in both groups. Grade 3 or 4 hypocalcemia, mostly without clinical sequelae, was more frequent in denosumab-treated patients (denosumab 4 %, ZA 2 %). Osteonecrosis of the jaw occurred infrequently (denosumab 0.8 %, ZA 1.1 %).
conclusionsDenosumab was more effective in delaying or preventing SREs in patients with bone metastases from solid tumors and also prevented pain progression compared to ZA in this ad hoc analysis.
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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.