Gender | Age
Item
female patients ≥ 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent given.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma TNM clinical staging | Secondary malignant neoplasm of bone Quantity Radiology
Item
histologically confirmed stage iv breast cancer with at least one bone metastasis radiologically confirmed.
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
zoledronic acid Frequency Infusion Quantity
Item
previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
boolean
C0257685 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤2 .
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 1 year.
boolean
C0023671 (UMLS CUI [1])
zoledronic acid Infusion | Zometa
Item
more than 3 months since last infusion of zoledronic acid (zometa®).
boolean
C0257685 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0939788 (UMLS CUI [2])
Diphosphonates | zoledronic acid | Zometa
Item
treatments with other bisphosphonate than zoledronic acid (zometa®) at any time prior to study entry.
boolean
C0012544 (UMLS CUI [1])
C0257685 (UMLS CUI [2])
C0939788 (UMLS CUI [3])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine > 3 mg/dl (265 μmol/l) or calculated (cockcroft-gault formula) creatinine clearance (clcr) < 30 ml/min crcl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dl)])x 0.85
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Corrected serum calcium measurement
Item
corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/l) or > 12 mg/dl ( 3.0 mmol/l).
boolean
C0455288 (UMLS CUI [1])
Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Infection | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule
Item
current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C1400602 (UMLS CUI [4])
C0024687 (UMLS CUI [5,1])
C3714514 (UMLS CUI [5,2])
C1301685 (UMLS CUI [6])
C2711248 (UMLS CUI [7])
C2013525 (UMLS CUI [8])
Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
C0040440 (UMLS CUI [3])
C0011370 (UMLS CUI [4])
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Sexual Abstinence | Contraceptives, Oral | Contraceptive implant | Intrauterine Devices | Contraceptive Sponge | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides
Item
pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, iud, vaginal diaphragm or sponge, or condom with spermicide).
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0087145 (UMLS CUI [12])
Compliance behavior Limited
Item
history of non-compliance to medical regimens or potential unreliable behavior.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Class
Item
known sensitivity to study drug(s) or class of study drug(s).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
Medical condition Severe Study Subject Participation Status Exclusion
Item
patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
Investigational New Drugs
Item
use of any other investigational agent in the last 30 days.
boolean
C0013230 (UMLS CUI [1])