Denosumab

Generic Name: Denosumab

Brand Names: Prolia, Xgeva, Wyost, Jubbonti

Drug Type: Biotech

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 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. FDA approved on June 1, 2010.

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 used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

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

Clinical Trials

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

Phase 2

Completed

Conditions: Calcific Aortic Stenosis

Interventions: Drug: Alendronic Acid Placebo
Drug: Alendronic Acid
Drug: Denosumab
Drug: Denosumab Placebo

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

Phase 3

Terminated

Conditions: Lung Cancer Non-small Cell Stage IV

Interventions: Other: None, standard chemotherapy only
Drug: Denosumab

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

Phase 1

Completed

Conditions: Healthy Volunteer, Female, Breast

Interventions: Drug: Denosumab
Procedure: Percutaneous core needle breast biopsy

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

Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Denosumab CP4
Drug: Denosumab CP2

First Posted Date: 2014-02-04

Last Posted Date: 2017-12-29

Lead Sponsor: Amgen

Target Recruit Count: 146

Registration Number: NCT02053753

Locations: 🇺🇸
Research Site, San Antonio, Texas, United States

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks

Phase 3

Active, not recruiting

Conditions: Metastatic Breast Cancer
Metastatic Prostate Cancer
Bone Metastases

Interventions: Drug: Denosumab (standard dosing)
Drug: Denosumab (reduced dosing)

First Posted Date: 2014-01-31

Last Posted Date: 2025-03-13

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 1380

Registration Number: NCT02051218

Locations: 🇦🇹
Landeskrankenhaus Feldkirch, Feldkirch, Austria
🇨🇭
Universitaetsspital Basel, Basel, Switzerland
🇨🇭
Clinique De Genolier, Genolier, Switzerland

and more 46 locations

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

Phase 2

Completed

Conditions: Adult Idiopathic Generalized Osteoporosis

Interventions: Drug: Denosumab

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

Phase 3

Completed

Conditions: Osteoporosis, Postmenopausal

Interventions: Drug: Placebo
Drug: Denosumab
Dietary Supplement: Elemental Calcium
Dietary Supplement: Vitamin D

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

Phase 4

Conditions: Osteoporosis
Spinal Cord Injury

Interventions: Drug: Placebo (identical Denosumab volume of normal saline)
Drug: Denosumab

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