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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01344967
First received: April 28, 2011
Last updated: May 13, 2011
Last verified: December 2010
History of Changes

April 28, 2011
May 13, 2011
February 2009
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01344967 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect
Not Provided

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.
Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Metastatic Breast Cancer With Bone Involvement
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
Experimental: Zometa, Bone Suppression, Active Ingredient
Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
December 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Tazmin Usmani, BHA 416-946-4501 ext 2411 tazmin.usmani@uhn.on.ca
Contact: Margaret Molnar 416-581-7892 margaret.molnar@uhn.on.ca
Canada
 
NCT01344967
UHN-080520C
Not Provided
Dr. Pamela Goodwin, Princess Margaret Hospital
University Health Network, Toronto
Canadian Breast Cancer Foundation
Not Provided
University Health Network, Toronto
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP