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
- -
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
- Conditions
- Interventions
- First Posted Date
- 2018-08-20
- Last Posted Date
- 2022-12-20
- Lead Sponsor
- Amgen
- Target Recruit Count
- 75
- Registration Number
- NCT03638128
- Locations
- 🇬🇧
Birmingham Childrens Hospital, Birmingham, United Kingdom
🇦🇺Perth Childrens Hospital, Nedlands, Western Australia, Australia
🇨🇦Shriners Hospital for Children, Montreal, Quebec, Canada
RANKL Inhibition and Breast Tissue Biomarkers
- Conditions
- Interventions
- First Posted Date
- 2018-08-14
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 10
- Registration Number
- NCT03629717
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
- Conditions
- Interventions
- First Posted Date
- 2018-08-09
- Last Posted Date
- 2023-06-07
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 51
- Registration Number
- NCT03623633
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
- Conditions
- Interventions
- First Posted Date
- 2018-08-08
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 25
- Registration Number
- NCT03620019
- Locations
- 🇺🇸
Dartmouth-Hitchcock Medical Center, Manchester, New Hampshire, United States
🇺🇸UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Denosumab in Subjects With Giant Cell Rich Tumors of Bone
- Conditions
- Interventions
- First Posted Date
- 2018-07-30
- Last Posted Date
- 2019-08-26
- Lead Sponsor
- Leiden University Medical Center
- Target Recruit Count
- 60
- Registration Number
- NCT03605199
- Locations
- 🇮🇹
Istituto Ortopedico Rizzoli, Bologna, Italy
🇳🇱Leiden University Medical Center, Leiden, Netherlands
🇫🇷Centre Léon Bérard, Lyon, France
Denosumab Treatment for Fibrous Dysplasia
- First Posted Date
- 2018-06-27
- Last Posted Date
- 2022-02-18
- Target Recruit Count
- 9
- Registration Number
- NCT03571191
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
- First Posted Date
- 2018-05-09
- Last Posted Date
- 2021-11-23
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 6
- Registration Number
- NCT03520231
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies
- First Posted Date
- 2018-01-24
- Last Posted Date
- 2021-10-22
- Lead Sponsor
- Centre Leon Berard
- Target Recruit Count
- 1
- Registration Number
- NCT03408652
- Locations
- 🇫🇷
Centre Leon Berard, Lyon, France
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis
- Conditions
- Interventions
- First Posted Date
- 2018-01-17
- Last Posted Date
- 2024-05-03
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 24
- Registration Number
- NCT03401060
- Locations
- 🇫🇷
La Pitié-Salpêtrière Hospital, Internal medicine and clinical immunology department, Paris, France
🇫🇷Cochin Hospital, Rheumatology department, Paris, France
🇫🇷Toulouse Hospital, Dermatology department, Toulouse, France
Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China
- Conditions
- Interventions
- First Posted Date
- 2017-11-30
- Last Posted Date
- 2017-11-30
- Lead Sponsor
- Peking University People's Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT03358212
Drug Development Updates
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