Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
Brief Summary: Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.


Options:
A: Arm Label: IV Bisphosphonates q 4 weeks; Type: ACTIVE_COMPARATOR; Interventions: Drug: IV Bisphosphonate q 4 weeks | Arm Label: 180 mg AMG 162 (SC) q 12 weeks; Type: EXPERIMENTAL; Interventions: Genetic: AMG 162 180 mg (SC) q 12 weeks | Arm Label: 180 mg AMG 162 (SC) q 4 weeks; Type: EXPERIMENTAL; Interventions: Genetic: AMG 162- 180 mg q 4 weeks | Intervention Type: GENETIC; Name: AMG 162 180 mg (SC) q 12 weeks; Assigned to Arm(s): 180 mg AMG 162 (SC) q 12 weeks | Intervention Type: DRUG; Name: IV Bisphosphonate q 4 weeks; Assigned to Arm(s): IV Bisphosphonates q 4 weeks | Intervention Type: GENETIC; Name: AMG 162- 180 mg q 4 weeks; Assigned to Arm(s): 180 mg AMG 162 (SC) q 4 weeks
B: 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
C: 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
D: Arm Label: Arm A: Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: ADT | Arm Label: Arm B: Zoledronic Acid; Type: EXPERIMENTAL; Interventions: Drug: ADT, Drug: Zoledronic Acid | Arm Label: Arm C: Docetaxel; Type: EXPERIMENTAL; Interventions: Drug: Docetaxel, Drug: Prednisolone, Drug: ADT | Arm Label: Arm D: Celecoxib; Type: EXPERIMENTAL; Interventions: Drug: Celecoxib, Drug: ADT | Arm Label: Arm E: Zoledronic Acid & Docetaxel; Type: EXPERIMENTAL; Interventions: Drug: Docetaxel, Drug: Prednisolone, Drug: ADT, Drug: Zoledronic Acid | Arm Label: Arm F: Zoledronic Acid & Celecoxib; Type: EXPERIMENTAL; Interventions: Drug: Celecoxib, Drug: ADT, Drug: Zoledronic Acid | Arm Label: Arm G: Abiraterone; Type: EXPERIMENTAL; Interventions: Drug: Prednisolone, Drug: ADT, Drug: Abiraterone | Arm Label: Arm H: M1 RT; Type: EXPERIMENTAL; Interventions: Drug: ADT, Radiation: Radiotherapy to the prostate | Arm Label: Arm J: Abiraterone * Enzalutamide; Type: EXPERIMENTAL; Interventions: Drug: Prednisolone, Drug: ADT, Drug: Abiraterone, Drug: Enzalutamide | Arm Label: Arm K: Metformin; Type: EXPERIMENTAL; Interventions: Drug: ADT, Drug: Metformin | Arm Label: Arm L: tE2; Type: EXPERIMENTAL; Interventions: Drug: Transdermal Oestradiol | Intervention Type: DRUG; Name: Celecoxib; Assigned to Arm(s): Arm D: Celecoxib, Arm F: Zoledronic Acid & Celecoxib | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Arm C: Docetaxel, Arm E: Zoledronic Acid & Docetaxel | Intervention Type: DRUG; Name: Prednisolone; Assigned to Arm(s): Arm C: Docetaxel, Arm E: Zoledronic Acid & Docetaxel, Arm G: Abiraterone, Arm J: Abiraterone * Enzalutamide | Intervention Type: DRUG; Name: ADT; Assigned to Arm(s): Arm A: Standard of Care, Arm B: Zoledronic Acid, Arm C: Docetaxel, Arm D: Celecoxib, Arm E: Zoledronic Acid & Docetaxel, Arm F: Zoledronic Acid & Celecoxib, Arm G: Abiraterone, Arm H: M1 RT, Arm J: Abiraterone * Enzalutamide, Arm K: Metformin | Intervention Type: DRUG; Name: Zoledronic Acid; Assigned to Arm(s): Arm B: Zoledronic Acid, Arm E: Zoledronic Acid & Docetaxel, Arm F: Zoledronic Acid & Celecoxib | Intervention Type: DRUG; Name: Abiraterone; Assigned to Arm(s): Arm G: Abiraterone, Arm J: Abiraterone * Enzalutamide | Intervention Type: RADIATION; Name: Radiotherapy to the prostate; Assigned to Arm(s): Arm H: M1 RT | Intervention Type: DRUG; Name: Enzalutamide; Assigned to Arm(s): Arm J: Abiraterone * Enzalutamide | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Arm K: Metformin | Intervention Type: DRUG; Name: Transdermal Oestradiol; Assigned to Arm(s): Arm L: tE2

Answer: B