Denosumab
- Generic Name
- Denosumab
- Brand Names
- Prolia, Xgeva, Wyost, Jubbonti
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 615258-40-7
- Unique Ingredient Identifier
- 4EQZ6YO2HI
- Background
Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and...
- Indication
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be use...
- Associated Conditions
- Bone Fractures, Bone Giant Cell Tumor, Bone Loss, Bone pain, Spinal Cord Compression, Bone destruction, High risk of fracture Osteoporosis, Refractory Hypercalcemia of malignancy
- Associated Therapies
- -
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2009-02-06
- Last Posted Date
- 2018-10-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 384
- Registration Number
- NCT00838201
- Locations
- 🇵🇱
Research Site, Wroclaw, Poland
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
- Conditions
- Interventions
- First Posted Date
- 2008-05-20
- Last Posted Date
- 2015-03-12
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Target Recruit Count
- 1262
- Registration Number
- NCT00680953
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
- Conditions
- Interventions
- First Posted Date
- 2008-05-20
- Last Posted Date
- 2022-09-22
- Lead Sponsor
- Amgen
- Target Recruit Count
- 535
- Registration Number
- NCT00680992
- Locations
- 🇬🇧
Research Site, Birmingham, United Kingdom
Denosumab Adherence Preference Satisfaction Study
- First Posted Date
- 2007-08-20
- Last Posted Date
- 2019-12-03
- Lead Sponsor
- Amgen
- Target Recruit Count
- 250
- Registration Number
- NCT00518531
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
- First Posted Date
- 2006-05-26
- Last Posted Date
- 2011-01-24
- Lead Sponsor
- Amgen
- Target Recruit Count
- 1189
- Registration Number
- NCT00330460
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
- Conditions
- Interventions
- First Posted Date
- 2006-02-20
- Last Posted Date
- 2014-07-25
- Lead Sponsor
- Amgen
- Target Recruit Count
- 247
- Registration Number
- NCT00293813
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
- First Posted Date
- 2005-12-01
- Last Posted Date
- 2017-03-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 96
- Registration Number
- NCT00259740
Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
- First Posted Date
- 2004-11-08
- Last Posted Date
- 2021-10-25
- Lead Sponsor
- Amgen
- Target Recruit Count
- 227
- Registration Number
- NCT00095498
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
- First Posted Date
- 2004-08-16
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 7808
- Registration Number
- NCT00089791
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
- Conditions
- Interventions
- First Posted Date
- 2002-08-07
- Last Posted Date
- 2013-09-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 412
- Registration Number
- NCT00043186
Drug Development Updates
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