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
- -
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
- Conditions
- Interventions
- First Posted Date
- 2012-04-12
- Last Posted Date
- 2018-07-27
- Lead Sponsor
- Amgen
- Target Recruit Count
- 795
- Registration Number
- NCT01575873
- Locations
- 🇪🇸
Research Site, Madrid, Spain
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
- Conditions
- Interventions
- First Posted Date
- 2012-04-12
- Last Posted Date
- 2024-08-28
- Lead Sponsor
- Amgen
- Target Recruit Count
- 7180
- Registration Number
- NCT01575834
- Locations
- 🇬🇧
Research Site, Reading, United Kingdom
Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass
- Conditions
- Interventions
- First Posted Date
- 2012-04-06
- Last Posted Date
- 2013-01-17
- Lead Sponsor
- Aristotle University Of Thessaloniki
- Target Recruit Count
- 91
- Registration Number
- NCT01572545
- Locations
- 🇬🇷
251 Hellenic Air Force Hospital, Athens, Attikis, Greece
🇬🇷424 General Military Hospital, Thessaloniki, Greece
🇬🇷Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital, Thessaloniki, Greece
Denosumab in Primary Hyperparathyroidism
- First Posted Date
- 2012-03-20
- Last Posted Date
- 2022-11-02
- Lead Sponsor
- Columbia University
- Target Recruit Count
- 8
- Registration Number
- NCT01558115
- Locations
- 🇺🇸
Columbia University Medical Center, New York, New York, United States
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer
- First Posted Date
- 2012-03-07
- Last Posted Date
- 2020-01-02
- Lead Sponsor
- Hope Rugo, MD
- Target Recruit Count
- 4
- Registration Number
- NCT01545648
- Locations
- 🇺🇸
University of California San Francisco, San Francisco, California, United States
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
- First Posted Date
- 2011-12-19
- Last Posted Date
- 2014-02-07
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 250
- Registration Number
- NCT01495000
- Locations
- 🇮🇳
GSK Investigational Site, Vadodra, India
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
- First Posted Date
- 2011-11-06
- Last Posted Date
- 2015-05-12
- Lead Sponsor
- Tuen Mun Hospital
- Target Recruit Count
- 40
- Registration Number
- NCT01465568
- Locations
- 🇨🇳
Tuen Mun Hospital, Hong Kong, China
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
- First Posted Date
- 2011-11-04
- Last Posted Date
- 2016-02-19
- Lead Sponsor
- Amgen
- Target Recruit Count
- 32
- Registration Number
- NCT01464931
- Locations
- 🇺🇸
Research Site, San Antonio, Texas, United States
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
- Conditions
- Interventions
- First Posted Date
- 2011-10-24
- Last Posted Date
- 2014-05-07
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 135
- Registration Number
- NCT01457950
- Locations
- 🇰🇷
GSK Investigational Site, Suwon, Korea, Republic of
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
- Conditions
- Interventions
- First Posted Date
- 2011-08-18
- Last Posted Date
- 2019-09-24
- Lead Sponsor
- Amgen
- Target Recruit Count
- 129
- Registration Number
- NCT01419717
- Locations
- 🇺🇦
Research Site, Lviv, Ukraine
Drug Development Updates
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