Clinical trials: Denosumab
Castrate Resistant Prostate Cancer With Bone Metastasis
Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC
Studies objectives: To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below: Safety and Tolerability: Adverse…
- Trial name
- NCT02864784
- Testing
- Amorphous calcium carbonate
- Where
- Israel
- Sponsor
- Amorphical Ltd.
Postmenopausal Women Osteoporosis
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with…
- Trial name
- NCT06804590
- Testing
- 9MW0311, Prolia®
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Postmenopausal
A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture
This is a randomized, double-blind, international multicentre, parallel-controlled phase III clinical study. The study plans to enroll 478 postmenopausal women with osteoporosis at high risk of fracture, whom will be randomized…
- Trial name
- NCT05352516
- Testing
- HLX14, Prolia®
- Where
- 38 sites in China
- Volunteers
- 514 people
- Sponsor
- Shanghai Henlius Biotech
Osteoporosis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
- Trial name
- NCT03822078
- Testing
- Denosumab
- Volunteers
- 45 people
- Sponsor
- Amgen
Osteoporosis
Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
- Trial name
- NCT06332014
- Testing
- Prolia
- Where
- 16 sites in China
- Volunteers
- 102 people
- Sponsor
- Amgen
Osteoporosis
Denosumab Safety Assessment in Multiple Observational Databases
This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources, US Medicare, Optum Research Database (formerly United HealthCare), Scandinavian national health…
- Trial name
- NCT02520362
- Testing
- denosumab, bisphosphonate
- Volunteers
- 517,991 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative…
- Trial name
- NCT05087030
- Testing
- RGB-14-P, Prolia®
- Where
- 59 sites in United States, Bulgaria and 6 more
- Volunteers
- 473 people
- Sponsor
- Gedeon Richter Plc.
Healthy Adults
A Study to Evaluate the Denosumab in Healthy Adults
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection…
- Trial name
- NCT03427853
- Testing
- LY06006
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Osteoporosis, Postmenopausal
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
- Trial name
- NCT01457950
- Testing
- denosumab, open-label denosumab
- Where
- 10 sites in South Korea
- Volunteers
- 135 people
- Sponsor
- GlaxoSmithKline
Thalassemia Majors (Beta-Thalassemia Major), Osteoporosis
Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis
This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With Beta Thalassemia Major Induced Osteoporosis.
- Trial name
- DOHA (NCT03040765)
- Testing
- Denosumab 60 MG/ML Prefilled Syringe, Zoledronic Acid 5Mg/Bag 100Ml Inj
- Where
- Qatar
- Volunteers
- 17 people
- Sponsor
- Hamad Medical Corporation
Low Bone Mineral Density
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD.
- Trial name
- NCT00043186
- Testing
- Denosumab, Alendronate
- Volunteers
- 412 people
- Sponsor
- Amgen
Glucocorticoid-induced Osteoporosis
A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.
- Trial name
- NCT06588153
- Testing
- Prolia®
- Where
- 16 sites in China
- Volunteers
- 102 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).
- Trial name
- NCT00095498
- Testing
- denosumab
- Volunteers
- 227 people
- Sponsor
- Amgen
Osteoporosis
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily…
- Trial name
- NCT00919711
- Testing
- Actonel®, Denosumab
- Volunteers
- 870 people
- Sponsor
- Amgen
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Postmenopausal Osteoporosis
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
- Trial name
- FRAME (NCT01575834)
- Testing
- Romosozumab, Denosumab
- Where
- 218 sites in United States, Argentina and 22 more
- Volunteers
- 7,180 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
- Trial name
- NCT01668589
- Where
- 144 sites in Austria, Belgium and 2 more
- Volunteers
- 1,501 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General…
- Trial name
- NCT05419427
- Testing
- Denosumab, Denosumab-Ref
- Where
- India
- Volunteers
- 552 people
- Sponsor
- Lambda Therapeutic Research Ltd.
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
- 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
- NCT00104650
- Testing
- AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
- Volunteers
- 111 people
- Sponsor
- Amgen
Calcium, Osteoporosis
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Using the FREEDOM substudy as a benchmark, evaluate the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, both with and without the combination of Denosumab treatment.
- Conditions
- Calcium, Osteoporosis, Bone Mineral Density, Bone Turnover Marker
- Trial name
- NCT06728462
- Testing
- Amorphous calcium carbonate
- Where
- Taiwan
- Volunteers
- 205 people
- Sponsor
- Universal Integrated Corp.