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

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Osteopenia; Cataract; Low Bone Mineral Density; Cancer; Prostate Cancer

Treatments: Biological: Denosumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925600

2009-012076-26 (EudraCT Number)

20080560

Details and patient eligibility

About

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.

Enrollment: 769 patients

Sex: Male

Ages: 30 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

769 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.

Treatment:

Biological: Placebo

Denosumab

Experimental group

Description:

Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.

Treatment:

Biological: Denosumab