Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Brief Summary: RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.


Options:
A: Intervention Type: DRUG; Name: clodronate disodium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: mitoxantrone hydrochloride; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: prednisone; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): N/A
B: Arm Label: Zoledronic acid + androgen deprivation therapy; Type: EXPERIMENTAL; Interventions: Drug: zoledronic acid, Drug: androgen deprivation therapy, Drug: GnRH agonist, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D | Arm Label: Placebo + androgen deprivation therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: placebo, Drug: androgen deprivation therapy, Drug: GnRH agonist, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D | Intervention Type: DRUG; Name: zoledronic acid; Assigned to Arm(s): Zoledronic acid + androgen deprivation therapy | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo + androgen deprivation therapy | Intervention Type: DRUG; Name: androgen deprivation therapy; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DRUG; Name: GnRH agonist; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DIETARY_SUPPLEMENT; Name: Calcium supplement; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy
C: Arm Label: zoledronic acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: zoledronic acid | Arm Label: denosumab; Type: EXPERIMENTAL; Interventions: Biological: denosumab | Intervention Type: DRUG; Name: zoledronic acid; Assigned to Arm(s): zoledronic acid | Intervention Type: BIOLOGICAL; Name: denosumab; Assigned to Arm(s): denosumab
D: Arm Label: Experimental Arm; Type: EXPERIMENTAL; Interventions: Drug: Risedronate | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Risedronate; Assigned to Arm(s): Experimental Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Arm

Answer: B