Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00334139
First received: June 2, 2006
Last updated: August 6, 2012
Last verified: August 2012
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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 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Bone turnover assessed by bone turnover parameters [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- Change in prostate specific antigen [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- Correlation between pain and bone turnover [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Correlation between bone complications and bone turnover [ Time Frame: end of study ] [ Designated as safety issue: No ]
| Enrollment: | 411 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: zoledronic acid |
Drug: Zoledronic Acid
every 4 weeks for 4 months
Other Name: ZOL446
|
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 More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00334139 History of Changes |
| Other Study ID Numbers: | CZOL446EDE28 |
| Study First Received: | June 2, 2006 |
| Last Updated: | August 6, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes |
Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
