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
-

Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2015-02-02
Last Posted Date
2022-12-28
Lead Sponsor
Amgen
Target Recruit Count
153
Registration Number
NCT02352753
Locations
🇬🇧

Research Site, Sheffield, United Kingdom

The Efficacy of Denosumab in Active Crohn's Disease

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-12-22
Last Posted Date
2018-10-15
Lead Sponsor
University of Manitoba
Target Recruit Count
2
Registration Number
NCT02321280
Locations
🇨🇦

University of Manitoba, Winnipeg, Manitoba, Canada

Denosumab for Treating Periprosthetic Osteolysis.

Phase 2
Conditions
Interventions
First Posted Date
2014-11-24
Last Posted Date
2019-02-07
Lead Sponsor
Olof Skoldenberg
Target Recruit Count
20
Registration Number
NCT02299817
Locations
🇸🇪

Danderyd Hospital, Stockholm, Sweden

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

First Posted Date
2014-06-27
Last Posted Date
2021-02-09
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
76
Registration Number
NCT02176382
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.

First Posted Date
2014-05-06
Last Posted Date
2021-10-14
Lead Sponsor
University of Edinburgh
Target Recruit Count
152
Registration Number
NCT02132026
Locations
🇬🇧

Clinical Research Facility University of Edinburgh, Edinburgh, United Kingdom

Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy

First Posted Date
2014-05-02
Last Posted Date
2024-04-25
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
595
Registration Number
NCT02129699
Locations
🇦🇹

Univ. Klinik für Innere Medizin V, Innsbruck, Austria

🇦🇹

KH der Elisabethinen Linz, Linz, Austria

🇦🇹

AKH Wien, Wien, Austria

and more 63 locations

Effect of Denosumab on Cellular Biomarkers in the Human Breast

First Posted Date
2014-03-31
Last Posted Date
2015-09-24
Lead Sponsor
Amgen
Target Recruit Count
82
Registration Number
NCT02099461
Locations
🇺🇸

Research Site, Miami, Florida, United States

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-01-30
Last Posted Date
2022-12-12
Lead Sponsor
Elizabeth Shane
Target Recruit Count
33
Registration Number
NCT02049866
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

🇺🇸

Creighton University, Omaha, Nebraska, United States

Denosumab China Phase III Study

First Posted Date
2013-12-18
Last Posted Date
2016-10-31
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
486
Registration Number
NCT02014467
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

Denosumab Administration After Spinal Cord Injury

First Posted Date
2013-11-14
Last Posted Date
2019-03-08
Lead Sponsor
James J. Peters Veterans Affairs Medical Center
Target Recruit Count
24
Registration Number
NCT01983475
Locations
🇺🇸

James J. Peters VA Medical Center, Bronx, New York, United States

🇺🇸

Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

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