Know Cancer

forgot password

Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Inclusion Criteria:

- Female patients with histologically confirmed incident invasive breast cancer (T1-4)
with positive hormone receptor status (ER and/or PgR positive) and no evidence of
regional lymph node metastasis (N0) or distant metastasis (M0)

- Patient has undergone complete primary tumor resection and axillary lymph node
dissection less than 90 days before start of study drug treatment.

- Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular
menses with premenopausal estradiol levels (>10 ng/dL)

- Patient receives adjuvant standard chemoendocrine or endocrine therapy

- Bone density at study entry > -2.5 T-Score

Exclusion Criteria:

- History of treatment or disease affecting bone metabolism (e.g., Paget's disease,
primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for
osteoporosis in addition to calcium and vitamin D

- Abnormal renal function

- Current active dental problems including infection of the teeth or jawbone (maxilla
or mandibular); dental or fixture trauma, or a current or prior diagnosis of
osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing
after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery
(e.g. extraction, implants)

- Pregnancy or lactation

- Women of childbearing potential not applying a medically recognized form of
contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or
sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in bone mineral density (BMD) measured by DXA at lumbar spine (L2-L4) between baseline and 24 months

Outcome Time Frame:

at 2 years

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Premenopausal
  • Bone mineral density
  • Cancer therapy induced bone loss
  • zoledronic acid
  • Breast Neoplasms