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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT01344967
• Date of registration: 28/04/2011
• Prospective Registration: No
• Primary sponsor: University Health Network, Toronto
• Public title: Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Patients With Metastatic Breast Cancer: Duration of Effect SuBDuE
• Date of first enrolment: February 2009
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01344967
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer With Bone Involvement

Intervention(s)

Drug: Zoledronic acid

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

UHN-080520C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Breast Cancer Foundation