Clinical trial · Interventional
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
NCT00181584CI-TRIAL-00011340completedPhase 2ClinicalTrials.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 primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
Conditions
Conditions (2)
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 Loss | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- interventionNames
- Drug: Zoledronic acid
- type
- PLACEBO_COMPARATOR
- label
- Group 2
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate * Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months * Corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl * Serum creatinine \< 2.0mg/dl Exclusion Criteria: * History of bone metastases by bone scan * Treatment with bisphosphonate within one year * History of metabolic disease * Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year
References
Publications (0)
Data not yet available
No reference posted for this study.