Trial reportClinical drug investigation2006
Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial.
Trial report in Clinical drug investigation, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Pooled it
- Pooled it
- Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease.Journal of cancer research and clinical oncology · 2008Trial
- Management of bone metastases in patients with breast cancer: review of bone-modifying therapy, emerging new agents, and future directions.Frontiers in oncology · 2026Review
- Real-world practice patterns and attitudes towards de-escalation of bone-modifying agents in patients with bone metastases from breast and prostate cancer: A physician survey.Journal of bone oncology · 2021Article
- National consensus in China on diagnosis and treatment of patients with advanced breast cancer.Annals of translational medicine · 2015Review
- Collapsing focal segmental glomerulosclerosis following long-term treatment with oral ibandronate: case report and review of literature.BMC cancer · 2015Review
- Bone pain reduction in patients with metastatic breast cancer treated with ibandronate-results from a post-marketing surveillance study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2010Article
- Metastatic bone pain: treatment options with an emphasis on bisphosphonates.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2008Review
- Use of ibandronate in the prevention of skeletal events in metastatic breast cancer.Therapeutics and clinical risk management · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveDespite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years. PATIENTS AND
methodsDuring an initial 96-week period, breast cancer patients with bone metastases were randomised in double-blind fashion to placebo or ibandronic acid 6mg administered by intravenous infusion over 1-2 hours every 3-4 weeks as part of a previously reported phase III trial (MF 4265 study). All patients completing the phase III trial were offered open-label active treatment for a further 96 weeks (extension phase). A total of 62 patients received ibandronic acid 6mg in this extension phase and were classified according to their initial treatment (placebo/ibandronic acid 6mg [placebo/6mg] and ibandronic acid 6mg/ibandronic acid 6mg [6mg/6mg] groups). Safety was assessed by AE reports and clinical laboratory evaluations.
resultsDuring the 4-year study, most patients experienced at least one AE, with malignancy progression being most commonly reported. However, fewer treatment-related AEs were reported in the extension phase (placebo/6mg: 6.3% [1/16]; 6mg/6mg: 13.0% [6/46]) than in the initial phase of the study (placebo: 56.3% [9/16]; 6mg: 67.4% [31/46]). Serious AEs were mainly due to malignancy progression. There were no clinically relevant renal AEs, and in both groups, serum creatinine levels were similar for up to 4 years.
conclusionThis 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.
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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.