Clinical trial · Interventional
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
NCT00172055CI-TRIAL-00026300completedPhase 3ClinicalTrials.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)
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Prostate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZOL446 (zoledronic acid)
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (1)
- measure
- If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
- timeFrame
- at 6 months
Secondary outcomes (1)
- measure
- If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases
- timeFrame
- at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All stages of prostate cancer without bone metastases * No evidence of severe osteoporosis * ECOG performance status 0, 1 or 2 Exclusion Criteria: * Surgery / fracture at the lumbosacral spine, bilateral hip implants * Evidence of metabolic bone diseases, * Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment * Abnormal kidney or liver function * Other cancers within the last 5 years Other protocol-defined exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.