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
-

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Phase 4
Completed
Conditions
Interventions
First Posted Date
2017-10-04
Last Posted Date
2024-05-20
Lead Sponsor
Amgen
Target Recruit Count
85
Registration Number
NCT03301857
Locations
🇺🇸

Sarcoma Oncology Research Center LLC, Santa Monica, California, United States

🇺🇸

Mount Sinai Beth Israel Downtown, New York, New York, United States

🇺🇸

University of Minnesota Medical Center Fairview, Minneapolis, Minnesota, United States

and more 11 locations

Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women

First Posted Date
2017-09-26
Last Posted Date
2020-07-10
Lead Sponsor
AryoGen Pharmed Co.
Target Recruit Count
190
Registration Number
NCT03293108
Locations
🇮🇷

Rheumatology Center of Iran, Tehran, Iran, Islamic Republic of

Characteristics and Mechanism of Denosumab-treated Giant Cell Tumor of Bone

Phase 3
Conditions
Interventions
First Posted Date
2017-08-23
Last Posted Date
2017-08-24
Lead Sponsor
Hebei Medical University Third Hospital
Target Recruit Count
30
Registration Number
NCT03259152
Locations
🇨🇳

Zhuang Zhou, Shijiazhuang, Hebei, China

Effect of Denosumab in Erosion Healing in RA

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-08-03
Last Posted Date
2020-11-24
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
110
Registration Number
NCT03239080
Locations
🇨🇳

Department of Medicine and Therapeutics, Hong Kong, China

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-06-02
Last Posted Date
2019-10-23
Lead Sponsor
Western University of Health Sciences
Target Recruit Count
7
Registration Number
NCT03174366
Locations
🇺🇸

Western University of Health Sciences, Pomona, California, United States

Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

First Posted Date
2017-05-24
Last Posted Date
2024-07-19
Lead Sponsor
Amgen
Target Recruit Count
24
Registration Number
NCT03164928
Locations
🇦🇺

Perth Childrens Hospital, Nedlands, Western Australia, Australia

🇷🇺

FSAI Scientific Center of Childrens Health of MoH of the RF, Moscow, Russian Federation

🇹🇷

Ankara Universitesi Tip Fakultesi, Ankara, Turkey

and more 35 locations

Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma

First Posted Date
2017-05-22
Last Posted Date
2022-04-07
Lead Sponsor
Melanoma and Skin Cancer Trials Limited
Target Recruit Count
72
Registration Number
NCT03161756
Locations
🇦🇺

Royal Hobart Hospital, Hobart, Tasmania, Australia

🇦🇺

Box Hill Hospital, Box Hill, Victoria, Australia

🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 7 locations

Denosumab and Male Infertility: a RCT

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-01-24
Last Posted Date
2023-06-13
Lead Sponsor
Martin Blomberg Jensen
Target Recruit Count
95
Registration Number
NCT03030196
Locations
🇩🇰

Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark

Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-12-29
Last Posted Date
2020-02-12
Lead Sponsor
Tuen Mun Hospital
Target Recruit Count
140
Registration Number
NCT03005678
Locations
🇨🇳

Department of Medicine, Tuen Mun Hospital, Hong Kong, China

Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-09-16
Last Posted Date
2021-11-02
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
20
Registration Number
NCT02903446
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

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