Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334139
• Other study ID #: CZOL446EDE28
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2006
• Last updated: February 3, 2017
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer.

The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment.

• Breast cancer with at least one cancer-related bone lesion

• Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2

• Normal liver and kidney function

• Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone.

Exclusion criteria:

• Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)

• Current/active dental problems including

• infection of the teeth or jawbone

• dental or fixture trauma

• current or previous osteonecrosis of the jaw

• exposed bone in the mouth

• slow healing after dental procedures

• recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)

• Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety

• Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG

• History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score =2.5).

• Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month

Additional protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic Acid
every 4 weeks for 4 months

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thadepalli H, Gorbach SL, Broido PW, Norsen J, Nyhus L. Abdominal trauma, anaerobes, and antibiotics. Surg Gynecol Obstet. 1973 Aug;137(2):270-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone turnover assessed by bone turnover parameters		every 30 days
Secondary	Pain		every 30 days
Secondary	Change in prostate specific antigen		every 30 days
Secondary	Quality of Life		every 30 days
Secondary	Correlation between pain and bone turnover		at end of study
Secondary	Correlation between bone complications and bone turnover		end of study

External Links

•   Results for CZOL446EDE28 from the Novartis Clinical Trials website