Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334139
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Breast Cancer Bone Metastasis Drug: Zoledronic Acid Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: zoledronic acid Drug: Zoledronic Acid
every 4 weeks for 4 months
Other Name: ZOL446




Primary Outcome Measures :
  1. Bone turnover assessed by bone turnover parameters [ Time Frame: every 30 days ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: every 30 days ]
  2. Change in prostate specific antigen [ Time Frame: every 30 days ]
  3. Quality of Life [ Time Frame: every 30 days ]
  4. Correlation between pain and bone turnover [ Time Frame: at end of study ]
  5. Correlation between bone complications and bone turnover [ Time Frame: end of study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334139


Locations
Layout table for location information
Germany
Novartis Investigative Site
Ulm, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00334139     History of Changes
Other Study ID Numbers: CZOL446EDE28
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
serum bone markers
bone metastasis
prostate cancer
breast cancer
quality of life
bisphosphonates
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs