Clinical trial · Interventional
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
NCT00859027CI-TRIAL-00032730completedPhase 4Results postedClinicalTrials.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)
Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo risedronate oral tablet | Drug | — | UNRESOLVED |
| risedronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Risedronate
- description
- 35 mg by mouth every week as directed
- interventionNames
- Drug: risedronate
- type
- PLACEBO_COMPARATOR
- label
- risedronate placebo tablet
- description
- Calcium and vitamin D
- interventionNames
- Drug: Placebo risedronate oral tablet
Primary outcomes (1)
- measure
- Percent Change in Bone Mineral Density
- timeFrame
- baseline and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Non-metastatic prostate cancer * Men to receive Gonadotropin-releasing Hormone-agonist therapy Exclusion Criteria: * Other cancers except skin cancer * Evidence of metabolic bone disease * Prior use of bisphosphonates
References
Publications (0)
Data not yet available
No reference posted for this study.