Clinical trial · Interventional
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy
NCT00925600CI-TRIAL-00027875completedPhase 3Results 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)
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cataract | — | UNRESOLVED | — |
| Low Bone Mineral Density | — | UNRESOLVED | — |
| Osteopenia | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Biological | Denosumab | ALIAS |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
- interventionNames
- Biological: Placebo
- type
- EXPERIMENTAL
- label
- Denosumab
- description
- Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
- interventionNames
- Biological: Denosumab
Primary outcomes (1)
- measure
- Percentage of Participants With Lens Opacification Event Development or Progression by Month 12
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 30 years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least 12 months * Adequate visual accuracy allowing eye testing * Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age * Signed informed consent Exclusion Criteria: * Previous surgery for cataracts in both eyes, current diagnosis of cataracts, cataracts surgery foreseen in the near future, or ocular disease leading to visual loss * Diagnosis of osteoporosis
References
Publications (0)
Data not yet available
No reference posted for this study.