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
-

Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-09-24
Last Posted Date
2019-08-26
Lead Sponsor
Ersi Voskaridou
Target Recruit Count
63
Registration Number
NCT02559648
Locations
🇬🇷

General Hospital of Athens "Laikon", Athens, Attica, Greece

Osteoclast Inhibition and Bone Formation

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-09-18
Last Posted Date
2018-01-05
Lead Sponsor
Mayo Clinic
Target Recruit Count
81
Registration Number
NCT02554695
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Denosumab Safety Assessment in Multiple Observational Databases

Completed
Conditions
Interventions
First Posted Date
2015-08-11
Last Posted Date
2024-11-04
Lead Sponsor
Amgen
Target Recruit Count
517991
Registration Number
NCT02520362

Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

First Posted Date
2015-07-16
Last Posted Date
2019-03-11
Lead Sponsor
424 General Military Hospital
Target Recruit Count
57
Registration Number
NCT02499237
Locations
🇬🇷

251 Airforce & VA General Hospital, Athens, Greece

🇬🇷

424 General Military Hospital, Thessaloniki, Greece

Effects of Denosumab Therapy for Japanese

Conditions
First Posted Date
2015-07-08
Last Posted Date
2016-11-25
Lead Sponsor
Tomidahama Hospital
Target Recruit Count
500
Registration Number
NCT02491515
Locations
🇯🇵

Tomidahama Hospital, Yokkaichi, Mie, Japan

Longjohn Amgen Study - Effect of Denosumab...

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2015-05-14
Last Posted Date
2020-11-10
Lead Sponsor
University of Southern California
Registration Number
NCT02444585
Locations
🇺🇸

Keck Medicine of USC, Los Angeles, California, United States

Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

Completed
Conditions
First Posted Date
2015-05-06
Last Posted Date
2018-10-29
Lead Sponsor
HealthEast Care System
Target Recruit Count
86
Registration Number
NCT02435147
Locations
🇺🇸

HealthEast Care System, Saint Paul, Minnesota, United States

TNFSF11 Inhibition and Fertility: a Prospective Study

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-04-21
Last Posted Date
2019-03-27
Lead Sponsor
Martin Blomberg Jensen
Target Recruit Count
12
Registration Number
NCT02422108
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

First Posted Date
2015-04-16
Last Posted Date
2019-12-06
Lead Sponsor
Indiana University
Registration Number
NCT02418273
Locations
🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer

First Posted Date
2015-02-19
Last Posted Date
2021-10-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
45
Registration Number
NCT02366130
Locations
🇺🇸

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

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