Phase 3 N=769 Randomized Quadruple-blind Supportive Care

Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss

Cancer · Cataract · Low Bone Mineral Density · Osteopenia · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00925600 ↗

Enrolled (actual)

769

Serious AEs

12.3%

Results posted

May 2017

Primary outcome: Primary: Percentage of Participants With Lens Opacification Event Development or Progression by Month 12 — 33.2; 33.5 percentage of participants — p=0.0026

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Denosumab (Biological); Placebo (Biological)
Age: Adult, Older Adult · 30+ yrs
Sex: Male
Sponsor: Amgen
Primary completion: May 2016

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

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.

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

View full record on ClinicalTrials.gov →

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.