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

Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations.

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]
Biological: Tyrosine Kinase Inhibitor
Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

First Posted Date: 2019-05-22

Last Posted Date: 2025-05-21

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 100

Registration Number: NCT03958565

Locations: 🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
Lone Tree Medical Center, Lone Tree, Colorado, United States

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

Phase 1

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: CMAB807
Drug: Prolia®

First Posted Date: 2019-04-23

Last Posted Date: 2020-10-14

Lead Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.

Target Recruit Count: 132

Registration Number: NCT03925051

Locations: 🇨🇳
Zhongshan Hospital, Shanghai, Shanghai, China

Denosumab In Ebv Nasopharyngeal Carcinoma As A Model For RankMediated Immunologic Modulation Of Virus-Related Tumours

Phase 2

Conditions: Nasopharyngeal Carcinoma
EBV Related Carcinoma

Interventions: Drug: Chemotherapy as clinical standard of care
Drug: Denosumab Inj 120 MG/1.7ML

First Posted Date: 2019-04-23

Last Posted Date: 2020-02-17

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 45

Registration Number: NCT03923842

Locations: 🇮🇹
ASST degli Spedali Civili di Brescia, Brescia, Italy
🇮🇹
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

Markers of Osteoporosis in Cystic Fibrosis

Phase 4

Recruiting

Conditions: Cystic Fibrosis

Interventions: Drug: Denosumab

First Posted Date: 2019-04-19

Last Posted Date: 2025-04-15

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 in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.

Phase 2

Terminated

Conditions: Castration-resistant Prostate Cancer
Bone Metastases
Metastatic Cancer

Interventions: Drug: Xgeva
Drug: Xtandi

First Posted Date: 2019-03-11

Last Posted Date: 2023-04-13

Lead Sponsor: Cancer Trials Ireland

Target Recruit Count: 7

Registration Number: NCT03869762

Locations: 🇮🇪
Galway University Hospital, Galway, Connacht, Ireland
🇮🇪
University Hospital Waterford, Waterford, Munster, Ireland
🇮🇪
Sligo University Hospital, Sligo, Connacht, Ireland

and more 4 locations

Denosumab Sequential Therapy

Phase 4

Completed

Conditions: Osteoporosis

Interventions: Drug: Zoledronic Acid
Drug: Denosumab

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: Smoldering Multiple Myeloma

Interventions: Drug: Denosumab

First Posted Date: 2019-02-15

Last Posted Date: 2025-04-04

Lead Sponsor: University of Rochester

Target Recruit Count: 20

Registration Number: NCT03839459

Locations: 🇺🇸
University of Rochester, Rochester, New York, United States

Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Drug: Placebo 1.7 ml Subcutaneous Solution

First Posted Date: 2019-01-03

Last Posted Date: 2025-02-11

Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Target Recruit Count: 8

Registration Number: NCT03792763

Locations: 🇦🇹
Hanusch Krankenhaus der Österreichischen Gesundheitskasse, 3. Med. Abteilung, Wien, Austria
🇦🇹
LKH Hochsteiermark, Standort Leoben, Abteilung für Innere Medizin und Hämatologie und internistische Onkologie, Leoben, Austria
🇦🇹
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie, Linz, Austria

and more 7 locations

Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer

Early Phase 1

Conditions: Breast Neoplasm Female
Stage I Breast Cancer
Hormone Receptor Negative Neoplasm
Stage II Breast Cancer
Hormone Receptor Positive Tumor