Phase 3
Completed N=769
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
Source: ClinicalTrials.gov NCT00925600 ↗Enrolled (actual)
769
Serious AEs
12.3%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Lens Opacification Event Development or Progression by Month 12 — 33.2; 33.5 percentage of participants — p=0.0026
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Lens Opacification Event Development or Progression by Month 12 |
33.2; 33.5 | 0.0026 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00925600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.