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

Primary Purpose

Metastatic Breast Cancer With Bone Involvement

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metastatic Breast Cancer With Bone Involvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zometa, Bone Suppression, Active Ingredient

Arm Description

Outcomes

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

Secondary Outcome Measures

To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of Zoledronic Acid

Full Information

First Posted
April 28, 2011
Last Updated
June 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01344967
Brief Title
Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect
Acronym
SuBDuE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Breast Cancer Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer With Bone Involvement

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zometa, Bone Suppression, Active Ingredient
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Control No. 110322
Intervention Description
Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed breast cancer. 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). Patient has not yet started on BP therapy for metastatic breast cancer to bone. Renal (serum creatinine, BUN), hepatic (AST, ALT, Bilirubin) function within the institutional normal range as assessed within 1 month of study entry. Age >/= 18 years. Karnofsky performance status ≥ 50. Life expectancy > 6 months. Ability to understand and the willingness to sign a written informed consent document. 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. Patients may be on another clinical trial, if allowed by the Trial Steering Committee for that trial. Patients are willing to take calcium and vitamin D supplements as recommended, while on study. Exclusion Criteria: Hypersensitivity or known allergy to bisphosphonates. 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. Acute or chronic renal insufficiency. Hypocalcemia as defined by serum calcium less than institutional normal range. Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks), or presence of osteonecrosis of the jaw. Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved). Patients with baseline hypocalcemia. Patients who have received ZA for prevention of breast cancer treatment-induced osteopenia or osteoporosis within the last 1 year. History and/or electrocardiographic evidence of atrial fibrillation. Pregnancy or lactation.
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1N9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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