Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00130494
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent.
* Age \>= 18 years old.
* Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.
* Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.
* A maximum of two chemotherapy lines for metastatic disease.
* A maximum of two hormone therapy lines for metastatic disease.
* Normal, minimally altered renal function (serum creatinine \< 1.5 x Upper Normal Limit (UNL)).
* Normal serum calcium levels.
* Performance status 0,1 (World Health Organization (WHO)).
* Negative pregnancy test before study recruitment.
Exclusion Criteria:
* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.
* Metastasis in CNS.
* History of hypersensitivity to bisphosphonates.
* Pregnant or lactating women.
* Third chemotherapy line for metastatic disease.
* Third hormone therapy line for metastatic disease.
* Males.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00130494
Study Brief:
Protocol Section:
NCT00130494