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

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01344967
First received: April 28, 2011
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Metastatic Breast Cancer With Bone Involvement
Drug: Zoledronic acid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344967

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01344967     History of Changes
Other Study ID Numbers: UHN-080520C
Study First Received: April 28, 2011
Last Updated: June 22, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 30, 2015