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

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Breast Cancer Bone Metastasis	Drug: Zoledronic Acid	Phase IV

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Prostate Cancer

ChemIDplus related topics:

Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Bone turnover assessed by bone turnover parameters

Secondary Outcome Measures:

Pain
Change in prostate specific antigen
Quality of Life
Correlation between pain and bone turnover
Correlation between bone complications and bone turnover

Estimated Enrollment:	600
Study Start Date:	June 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334139

Contacts


Contact: Novartis Basel	41 61 324 1111

Locations


Germany
		Recruiting
	Ulm, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446EDE28
First Received:	June 2, 2006
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00334139
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

serum bone markers

bone metastasis

prostate cancer

breast cancer

quality of life

bisphosphonates

Study placed in the following topic categories:

Zoledronic acid

Bone Neoplasms

Skin Diseases

Genital Neoplasms, Male

Prostatic Diseases

Hematologic Diseases

Bone neoplasms

Quality of Life

Breast Neoplasms

Urogenital Neoplasms

Genital Diseases, Male

Bone Diseases

Diphosphonates

Musculoskeletal Diseases

Neoplasm Metastasis

Bone Marrow Diseases

Prostatic Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00334139