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
-

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-11-09
Last Posted Date
2022-11-28
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
168
Registration Number
NCT04621318
Locations
🇺🇸

Biotrial, Newark, New Jersey, United States

🇫🇷

Biotrial Rennes, Rennes, France

Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

First Posted Date
2020-01-18
Last Posted Date
2024-05-10
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
36
Registration Number
NCT04232657
Locations
🇺🇸

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

🇺🇸

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

Circulating Myokine Levels and Bone Metabolism

First Posted Date
2019-12-20
Last Posted Date
2021-01-12
Lead Sponsor
424 General Military Hospital
Target Recruit Count
220
Registration Number
NCT04206618
Locations
🇬🇷

424 General Military Hospital, Thessaloniki, Northern Greece, Greece

Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

First Posted Date
2019-09-12
Last Posted Date
2024-11-20
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
36
Registration Number
NCT04087096
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

RANKL Inhibition and Mammographic Breast Density

First Posted Date
2019-08-26
Last Posted Date
2024-10-31
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
210
Registration Number
NCT04067726
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid

First Posted Date
2019-07-26
Last Posted Date
2019-07-26
Lead Sponsor
Kwong Wah Hospital
Target Recruit Count
40
Registration Number
NCT04034199
Locations
🇭🇰

Kwong Wah Hospital, Hong Kong, Hong Kong

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

First Posted Date
2019-07-19
Last Posted Date
2023-08-02
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
37
Registration Number
NCT04026256
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Markers of Osteoporosis in Cystic Fibrosis

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2019-04-19
Last Posted Date
2024-04-10
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
100
Registration Number
NCT03921060
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Denosumab Sequential Therapy

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-03-08
Last Posted Date
2024-04-23
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
101
Registration Number
NCT03868033
Locations
🇨🇳

Department of Orthopedics, National Taiwan University Hospital, Taipei, N/A = Not Applicable, Taiwan

Denosumab for Smoldering Multiple Myeloma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-02-15
Last Posted Date
2024-02-12
Lead Sponsor
University of Rochester
Target Recruit Count
20
Registration Number
NCT03839459
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

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