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An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer

18 Years
Open (Enrolling)
Breast Neoplasms, Bone Loss

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Trial Information

An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer

Breast cancer is the most commonly diagnosed malignant disease and the leading cause of
cancer-related mortality among women.

Zoledronate is a bone-targeted bisphosphonate, which is used to treat osteoporosis and to
reduce the risk of skeletal morbidity in patients with bone metastases. Zoledronate can also
reduce the persistence of disseminated tumour cells in the bone marrow of women with
early-stage breast cancer. Nowadays, consensus is emerging that certain subsets of patients
with early-stage breast cancer may benefit from bisphosphonate therapy.

Inclusion Criteria:

- Female, age > 18.

- Postoperative breast cancer patients who have finished adjuvant chemotherapy or
unwilling to receive chemotherapy.

- T score < -2.0, or -2.0 < T score <-1.0 with any 2 of the following risk factors: T
score < -1.5, age > 65, BMI < 20kg/m^2, family history of hip fractures, age > 50
with brittle fracture history, oral steroid therapy > 6 months, receiving aromatase

- ECOG(Eastern Cooperative Oncology Group) physical state score:0-2.

- Breast cancer stage I-III confirmed by histological or cytological examination.

- Patients received radical surgery with estimated survival time > 12 months.

- Laboratory tests should be performed 1 week before enrollment and the results should
meet the following criteria: neutrophil count ≥ 1.5×10^9/L, platelet count ≥
100×10^9/L, hemoglobin ≥ 80g/L, serum bilirubin ≤ 1.0×ULN, AST and ALT ≤ 1.5×ULN,
Serum creatinine ≤ 1.0×ULN.

- Patients who never received intravenous bisphosphonate within 12 months before
enrollment and did not receive oral bisphosphonate within 3 weeks before enrollment.

- Informed consents should be signed by the participants or their guardians. All the
participants should be aware of the purpose and procedure of this study and willing
to participate in this study.

- Contraception required for those reproductive-aged women.

Exclusion Criteria:

- Pregnant or lactating women.

- Patients who have not signed informed consent.

- Patients received medical treatment which can affect bone metabolism (such as
calcitonin, mithramycin or gallium nitrate) within 2 weeks before enrollment.

- Bone metabolic diseases such as Paget's disease, epiphyseal dysplasia and primary or
secondary hyperthyroidism diagnosed within 12 months before enrollment.

- Liver function impairment which is defined as 2.5-fold or more increase in ALT or AST
levels compared with the upper limit of reference range.

- Refuse appropriate contraception (appropriate contraceptive options include female
sterilisation, intrauterine device, oral contraceptives and barrier contraception).

- Active dental diseases including dental infection, mandibular pain and maxillary or
mandibular trauma. Patients with mandibular osteonecrosis diagnosed currently or
previously, exposed bone or slow healing after oral surgery. Patients who will
receive dental or maxillofacial surgery (such as dental extraction and dental
implant) in the first 6 weeks after enrollment.

- Patients with dysgnosia or communication disorder who can't well understand our
study, cooperate with our staff or operate glucose monitor correctly.

- Combined with major organ dysfunction or other severe diseases such as severe
coronary disease, cardiovascular disease, myocardial infarction occurred within 12
months before enrollment, severe neurological or psychiatric diseases, severe
infection or active disseminated intravascular coagulation.

- Alcoholics or drug addicts.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Bone Mineral Density

Outcome Time Frame:

48 weeks

Safety Issue:


Principal Investigator

Shenming Wang, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

First Affiliated Hospital, Sun Yat-Sen University


China: Ethics Committee

Study ID:




Start Date:

July 2011

Completion Date:

June 2017

Related Keywords:

  • Breast Neoplasms
  • Bone Loss
  • Breast neoplasms
  • Zoledronate
  • Bone loss
  • Breast Neoplasms
  • Neoplasms