Clinical trial NCT00334139: Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Breast Cancer
Bone Metastasis
Keywords: serum bone markers
bone metastasis
prostate cancer
breast cancer
quality of life
bisphosphonates
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Bone turnover assessed by bone turnover parameters
timeFrame: every 30 days
Secondary outcomes:
measure: Pain
timeFrame: every 30 days
measure: Change in prostate specific antigen
timeFrame: every 30 days
measure: Quality of Life
timeFrame: every 30 days
measure: Correlation between pain and bone turnover
timeFrame: at end of study
measure: Correlation between bone complications and bone turnover
timeFrame: end of study
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Thadepalli H, Gorbach SL, Broido PW, Norsen J, Nyhus L. Abdominal trauma, anaerobes, and antibiotics. Surg Gynecol Obstet. 1973 Aug;137(2):270-6. No abstract available.