Clinical trial · Interventional
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed by the research committee
Summary
Brief summary (as posted)
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term 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 |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium gluconate | Drug | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
- interventionNames
- Dietary Supplement: cholecalciferol
- Drug: calcium gluconate
- Drug: zoledronic acid
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
- interventionNames
- Dietary Supplement: cholecalciferol
- Drug: calcium gluconate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Stage III or IV disease * Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration * Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade * Continued concurrent androgen deprivation therapy required throughout study participation * No bone metastases by baseline bone scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 1 year Hematopoietic * Not specified Hepatic * Bilirubin less than 3 times upper limit of normal (ULN) * AST and ALT less than 3 times ULN * No chronic liver disease Renal * Creatinine no greater than 2.0 mg/dL Other * Fertile patients must use effective contraception * No Paget's disease * No Cushing's disease * No hyperthyroidism * No hyperprolactinemia PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior chemotherapy for prostate cancer allowed Endocrine therapy * See Disease Characteristics * More than 12 months since prior suppressive doses of thyroxine or calcitonin * More than 6 months since prior corticosteroids * Concurrent corticosteroids allowed (after enrollment on study) Radiotherapy * Prior radiotherapy for prostate cancer allowed Surgery * See Disease Characteristics Other * More than 12 months since prior bisphosphonate therapy (oral or IV)
References
Publications (0)
Data not yet available