Prolia®

Generic Name: denosumab
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20010223Treatment of postmenopausal osteoporosis2

A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women with Low Bone Mineral Density

20030216Treatment of Postmenopausal Osteoporosis3

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis. FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months)

20040132Prevention of Postmenopausal3

A Randomized Double-Blind Study to Evaluate Denosumab in the Prevention of Postmenopausal Osteoporosis (DEnosumab FortifiEs BoNe Density – The DEFEND Trial)

20040135Nonmetastatic Breast Cancer3

A Randomized, Double-blind, Placebo-controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Nonmetastatic Breast Cancer

20040138Nonmetastatic Prostate Cancer3

A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Nonmetastatic Prostate Cancer

20040144Treatment of rheumatoid arthritis (RA)2A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
20050141Osteoporosis/Osteopenia3

A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab versus Alendronate Sodium in Postmenopausal Women with Low Bone Mineral Density

20050172Osteoporosis2

Dose Response Study of AMG 162 (denosumab) in subjects with Osteoporosis – A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (denosumab) in Japanese Postmenopausal Osteoporotic Subjects

20050179Prevention and Treatment of Osteoporosis2

A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment with Denosumab (AMG 162) and Alendronate Sodium in  Postmenopausal Women with Low Bone Mineral Density

20050233Postmenopausal Women with Low Bone Mineral Density3

An Open-label, Single-arm Extension Study to Evaluate the Long-term safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

20050234Treatment of Osteoporosis3b

A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy from Alendronate to Denosumab (AMG 162) in Postmenopausal Women with Low Bone Mineral Density (Study of Transitioning from AleNdronate to Denosumab - The STAND Trial)

20050241Clinical Pharmacology1A Randomized Study to Evaluate Safety of Transitioning From Alendronate to A Single Dose of Denosumab in Postmenopausal Women with Low Bone Mass
20060232Postmenopausal Women with Low Bone Mineral Density3

Multicenter, Randomized, Cross-over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal

20060237Treatment of Osteoporosis3b

A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Prefilled Syringe Compared to Vial in Subjects with Low Bone Mineral Density

20080098Low Bone Mineral Density3

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Denosumab versus Placebo in Males with Low Bone Mineral Density (BMD)

20080099Bone Mineral Density3

A Randomized Open Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy

20080287Low Bone Mass or Osteoporosis2

A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women with Low Bone Mass or Osteoporosis Previously Treated with Denosumab

20080537Nonmetastatic Prostate Cancer3

An Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety of Denosumab (AMG162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Nonmetastatic Prostate Cancer

20080562Bone Mineral Density3

A Randomized Open-label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-optimally Treated with Daily or Weekly Bisphosphonates

20101131Postmenopausal Osteoporotic Women1

The Effects of Denosumab on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Postmenopausal Osteoporotic Women

20110132Treatment of osteoporosis (OP) in postmenopausal women at increased risk of fracturesObservationalProspective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia in Routine Clinical Practice
20120351Osteoporosis1

An Open-label Study to Evaluate the Concentration of Denosumab in Seminal Fluid after a Single Subcutaneous Injection in Healthy Men