Clinical trial · Interventional
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
NCT00489905CI-TRIAL-00012441completedN/AClinicalTrials.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 purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
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 Density | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zolderonic acid (Zometa) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Bone mineral density of lumber spine
- timeFrame
- 12 months after administration of zolderonic acid
- measure
- Bone mineral density of femoral neck
- timeFrame
- 12 months after administration of zolderonic acid
Secondary outcomes (2)
- measure
- Change in serum creatinine, calcium, phosphate and alkaline phosphatase
- timeFrame
- From time of enrollment to 3 months after the last intervention
- measure
- Change in creatinine clearance
- timeFrame
- From time of enrollment to 3 months after the last intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults. Exclusion Criteria: * Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study. Patients who have: * Serum creatinine levels \>212 µmol/L (2.4 mg/dL). * Creatinine clearance \<50 ml/min. * WBC \<4.0x109/L, Hgb \<10 g/dL, platelets \<140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
References
Publications (0)
Data not yet available
No reference posted for this study.