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
- -
Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty
- Conditions
- Interventions
- First Posted Date
- 2011-05-24
- Last Posted Date
- 2022-08-29
- Target Recruit Count
- 24
- Registration Number
- NCT01358669
- Locations
- 🇬🇧
Academic Unit of Bone Metabolism, Sheffield, South Yorkshire, United Kingdom
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
- First Posted Date
- 2011-04-29
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 1718
- Registration Number
- NCT01345019
- Locations
- 🇬🇧
Research Site, Oxford, United Kingdom
Effects of Denosumab on the Pharmacokinetics of Etanercept
- Conditions
- Interventions
- First Posted Date
- 2011-02-11
- Last Posted Date
- 2017-06-20
- Lead Sponsor
- Amgen
- Target Recruit Count
- 19
- Registration Number
- NCT01294397
- Locations
- 🇺🇸
Research Site, Dallas, Texas, United States
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
- First Posted Date
- 2010-10-15
- Last Posted Date
- 2018-08-07
- Lead Sponsor
- Amgen
- Target Recruit Count
- 30
- Registration Number
- NCT01221727
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
- First Posted Date
- 2010-02-26
- Last Posted Date
- 2021-09-28
- Lead Sponsor
- Amgen
- Target Recruit Count
- 4509
- Registration Number
- NCT01077154
- Locations
- 🇬🇧
Research Site, Truro, United Kingdom
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
- First Posted Date
- 2009-07-10
- Last Posted Date
- 2013-02-11
- Lead Sponsor
- Amgen
- Target Recruit Count
- 833
- Registration Number
- NCT00936897
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
- First Posted Date
- 2009-06-23
- Last Posted Date
- 2018-06-29
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 94
- Registration Number
- NCT00926380
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
- First Posted Date
- 2009-06-12
- Last Posted Date
- 2020-07-28
- Lead Sponsor
- Amgen
- Target Recruit Count
- 870
- Registration Number
- NCT00919711
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
- First Posted Date
- 2009-05-11
- Last Posted Date
- 2022-09-22
- Lead Sponsor
- Amgen
- Target Recruit Count
- 419
- Registration Number
- NCT00896532
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
- First Posted Date
- 2009-05-11
- Last Posted Date
- 2018-10-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 33
- Registration Number
- NCT00896454
- Locations
- 🇵🇱
Research Site, Warszawa, Poland
Drug Development Updates
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