Clinical trials: Denosumab
Cancer, Giant Cell Tumors
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)
- Conditions
- Cancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors
- Trial name
- NCT00680992
- Testing
- Denosumab
- Where
- 33 sites in United States, Australia and 10 more
- Volunteers
- 535 people
- Sponsor
- Amgen
Cancer, Carcinoma
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity…
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer
- Trial name
- NCT00838201
- Testing
- Denosumab
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 384 people
- Sponsor
- Amgen
Healthy Adults
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
- Trial name
- NCT04198636
- Testing
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Low Bone Mineral Density
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
- Trial name
- NCT00325468
- Testing
- AMG 162
- Volunteers
- 200 people
- Sponsor
- Amgen
Healthy
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
- Trial name
- NCT04621318
- Testing
- Denosumab
- Where
- 2 sites in United States, France
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors.
- Trial name
- NCT07028268
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Healthy Volunteers
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
- Trial name
- DENARIUS (NCT05323708)
- Testing
- Bmab 1000, Prolia®
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Healthy Subject
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
- Trial name
- NCT06037395
- Testing
- CT-P41, US-licensed Prolia
- Where
- 2 sites in South Korea
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Celltrion
Breast Cancer, Metastases
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
- Conditions
- Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
- Trial name
- NCT00091832
- Testing
- Denosumab, IV Bisphosphonates
- Volunteers
- 255 people
- Sponsor
- Amgen
Bone Metastases
Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04812509
- Testing
- MW032, Xgeva
- Where
- China
- Volunteers
- 708 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either…
- Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
- Trial name
- NCT00950911
- Testing
- amg 162
- Where
- 17 sites in Czechia, United Kingdom
- Volunteers
- 35 people
- Sponsor
- Amgen
Bone Metastases
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04550949
- Testing
- QL1206, Xgeva
- Where
- 2 sites in China
- Volunteers
- 700 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection
This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics…
- Trial name
- NCT06095427
- Testing
- LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia
- Where
- 2 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shandong Boan Biotechnology Co., Ltd
Castrate-resistant Prostate Cancer
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer.
- Trial name
- NCT01824342
- Testing
- Denosumab
- Where
- 9 sites in Czechia, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
- Trial name
- NCT02157948
- Testing
- Denosumab (CP2), Denosumab (CP4)
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 394 people
- Sponsor
- Amgen
Breast Cancer, Low Bone Mineral Density
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
- Conditions
- Breast Cancer, Low Bone Mineral Density, Osteopenia
- Trial name
- NCT00089661
- Testing
- AMG 162 / Denosumab
- Volunteers
- 252 people
- Sponsor
- Amgen
Osteoporosis
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in…
- Trial name
- NCT00306189
- Testing
- 100 mg AMG 162, 60 mg AMG 162, 14 mg AMG 162
- Volunteers
- 212 people
- Sponsor
- Amgen
Healthy
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
- Trial name
- NCT04673799
- Testing
- MV088 injection, Prolia® injection
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Kunming Pharmaceuticals, Inc.