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
-

Effect of RANKL Inhibition on UV-induced Immunosuppression

First Posted Date
2013-11-07
Last Posted Date
2014-07-24
Lead Sponsor
Innovaderm Research Inc.
Target Recruit Count
31
Registration Number
NCT01978483
Locations
🇨🇦

Innovaderm Research Inc., Montreal, Quebec, Canada

AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2013-10-31
Last Posted Date
2020-02-12
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
679
Registration Number
NCT01973569

Denosumab for Breast Cancer With Bone Mets

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2013-09-27
Last Posted Date
2019-11-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
7
Registration Number
NCT01952054
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

First Posted Date
2013-09-26
Last Posted Date
2021-10-25
Lead Sponsor
Amgen
Target Recruit Count
226
Registration Number
NCT01951586
Locations
🇬🇧

Research Site, Preston, United Kingdom

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2013-05-30
Last Posted Date
2018-11-27
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
27
Registration Number
NCT01864798
Locations
🇦🇺

Royal Melbourne Hospital, Victoria, Australia

🇧🇪

Institute Jules Bordet, Brussels, Belgium

🇧🇪

Hopital Erasme, Brussels, Belgium

and more 3 locations

Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-02-27
Last Posted Date
2015-01-27
Lead Sponsor
University of Cologne
Target Recruit Count
10
Registration Number
NCT01799798
Locations
🇩🇪

University Cologne, Childrens Hospital, Cologne, Germany, Cologne, NRW, Germany

RA Denosumab on Bone Microstructure Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-01-17
Last Posted Date
2014-09-11
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
40
Registration Number
NCT01770106
Locations
🇭🇰

Prince of Wales Hospital, Shatin, N.t., Hong Kong

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

First Posted Date
2012-12-20
Last Posted Date
2015-10-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
69
Registration Number
NCT01753856
Locations
🇨🇦

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sainte-Foy, Quebec, Canada

Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo

First Posted Date
2012-11-28
Last Posted Date
2015-09-23
Lead Sponsor
Medical University of Vienna
Target Recruit Count
90
Registration Number
NCT01734824
Locations
🇦🇹

Medical University Vienna - St. Vincent Hospital, Vienna, Austria

Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-06-28
Last Posted Date
2017-04-05
Lead Sponsor
Hans Mallmin
Target Recruit Count
64
Registration Number
NCT01630941
Locations
🇸🇪

Department of Orthopedics, Uppsala, Sweden

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