Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00130494
Brief Summary:
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Detailed Description:
Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.
Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:
* quality of life,
* performance status,
* pain rating,
* analgesic administration and
* adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.
Study:
NCT00130494
Study Brief:
Protocol Section:
NCT00130494