Clinical trial · Interventional
Prevention of Osteoporosis in Men With Prostate Cancer
NCT00048841CI-TRIAL-00003228completedPhase 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 purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels. All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy. Bone density tests will be done every six months.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypogonadism | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alendronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- PA spine BMD over 1 year
- measure
- Change in PA spine BMD over 2nd year
Secondary outcomes (1)
- measure
- BMD at the hip and lateral spine
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Men age 50-85 * Stage D0 prostate cancer * On androgen deprivation therapy Exclusion Criteria: * Renal failure * Hyperthyroidism * Cushing's syndrome * Metabolic bone disease * Use of glucocorticoids * Use of certain anticonvulsants * On osteoporosis therapies * Nonprostate cancers
References
Publications (1)
- DERIVEDGreenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: a randomized trial. Ann Intern Med. 2007 Mar 20;146(6):416-24. doi: 10.7326/0003-4819-146-6-200703200-00006. PMID 17371886