Clinical trial · Interventional
Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
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
NCT00334139CI-TRIAL-00025825completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastasis | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- zoledronic acid
- interventionNames
- Drug: Zoledronic Acid
Primary outcomes (1)
- measure
- Bone turnover assessed by bone turnover parameters
- timeFrame
- every 30 days
Secondary outcomes (5)
- measure
- Pain
- timeFrame
- every 30 days
- measure
- Change in prostate specific antigen
- timeFrame
- every 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTThadepalli 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. PMID 4723349