Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect (SuBDuE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344967
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : June 23, 2015
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Close to two-thirds of women with bone metastases will go on to develop at least one of these complications, termed a skeletal related event (SRE), defined as 1) pathological fractures, 2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4) hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have some degree of pain associated with their disease. Understandably these factors negatively impact their quality of life. Furthermore, the development of an SRE in this population has been shown to be associated with shorter overall survival. Prevention or delay in onset of these complications is therefore an important therapeutic goal.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer With Bone Involvement Drug: Zoledronic acid Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zometa, Bone Suppression, Active Ingredient Drug: Zoledronic acid
Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
Other Name: Control No. 110322

Primary Outcome Measures :
  1. The primary objective of this study is to estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of Zoledronic Acid [ Time Frame: Baseline to Twelve weeks ]

Secondary Outcome Measures :
  1. To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of Zoledronic Acid [ Time Frame: Baseline to Twelve weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must have histologically confirmed breast cancer.
  2. Radiological or pathological evidence of bone metastases. (positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic breast cancer).
  3. Patient has not yet started on BP therapy for metastatic breast cancer to bone.
  4. Renal (serum creatinine, BUN), hepatic (AST, ALT, Bilirubin) function within the institutional normal range as assessed within 1 month of study entry.
  5. Age >/= 18 years.
  6. Karnofsky performance status ≥ 50.
  7. Life expectancy > 6 months.
  8. Ability to understand and the willingness to sign a written informed consent document.
  9. Patients may receive any chemotherapy, biological or endocrine treatment considered appropriate by the treating physician. This can be changed during the course of the study as clinically indicated.
  10. Patients may be on another clinical trial, if allowed by the Trial Steering Committee for that trial.
  11. Patients are willing to take calcium and vitamin D supplements as recommended, while on study.

Exclusion Criteria:

  1. Hypersensitivity or known allergy to bisphosphonates.
  2. Patient currently taking Bisphosphonate therapy for metastatic breast cancer to bone (Clodronate, Pamidronate, Zoledronic Acid, Ibandronate, Calcitonin). Bisphosphonates for the treatment of other bone disease (osteoporosis, osteopenia, Paget's disease, etc) but not Zoledronic Acid, are permitted.
  3. Acute or chronic renal insufficiency.
  4. Hypocalcemia as defined by serum calcium less than institutional normal range.
  5. Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks), or presence of osteonecrosis of the jaw.
  6. Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved).
  7. Patients with baseline hypocalcemia.
  8. Patients who have received ZA for prevention of breast cancer treatment-induced osteopenia or osteoporosis within the last 1 year.
  9. History and/or electrocardiographic evidence of atrial fibrillation.
  10. Pregnancy or lactation.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344967

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1N9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Breast Cancer Foundation

Responsible Party: University Health Network, Toronto Identifier: NCT01344967     History of Changes
Other Study ID Numbers: UHN-080520C
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs