Clinical trials: Denosumab
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.
- Trial name
- NCT03651947
- Testing
- QL1206, Xgeva®
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Post Menopausal Osteoporosis
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
- Trial name
- PILOTE (NCT02347865)
- Testing
- AMG 162 - Prolia
- Where
- France
- Volunteers
- 777 people
- Sponsor
- Amgen
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
Healthy Volunteers
Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers
This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807…
- Trial name
- NCT06361355
- Testing
- Post-change CMAB807, Prolia
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Prostate Cancer
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
- Trial name
- NCT00089674
- Testing
- AMG 162
- Volunteers
- 1,468 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Denosumab China Phase III Study
This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.
- Trial name
- NCT02014467
- Testing
- Denosumab, Elemental Calcium, Vitamin D
- Where
- 8 sites in China
- Volunteers
- 486 people
- Sponsor
- GlaxoSmithKline
Postmenopausal Osteoporosis
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of…
- Trial name
- NCT03925051
- Testing
- Prolia®, CMAB807
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Postmenopausal Osteoporosis
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
- Trial name
- NCT04940845
- Testing
- HS-20090-2, Prolia
- Where
- China
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Shanghai Hansoh Biomedical Co., Ltd
Osteoporosis, Age-Related
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
- Trial name
- NCT02732210
- Where
- 89 sites in United States, Canada
- Volunteers
- 935 people
- Sponsor
- Amgen
Osteonecrosis of the Jaw, Infection Leading to Hospitalization
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.
- Trial name
- NCT01967160
- Volunteers
- 2,560 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this…
- Trial name
- NCT00091793
- Testing
- AMG 162
- Volunteers
- 332 people
- Sponsor
- Amgen
Osteopenia, Osteoporosis
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who…
- Trial name
- NCT00523341
- Testing
- Denosumab
- Volunteers
- 4,550 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
- Trial name
- NCT04757376
- Testing
- CT-P41, US-licensed Prolia
- Where
- 20 sites in Estonia, Latvia and 2 more
- Volunteers
- 479 people
- Sponsor
- Celltrion
Fractures, Bone
A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors
This is a randomized, double-blind, double-dummy study designed to provide bridging data in an Asian population to Amgen's studies of denosumab in subjects with bone metastases from solid tumors.
- Trial name
- NCT01920568
- Testing
- Denosumab 70 mg/mL, Zoledronic acid 4 mg, Calcium supplement
- Where
- 25 sites in China, Singapore and 1 more
- Volunteers
- 487 people
- Sponsor
- GlaxoSmithKline
Healthy Male Subjects
AVT03 With Prolia in Healthy Male Subjects
This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old.
- Trial name
- NCT05126784
- Testing
- AVT03, Prolia
- Where
- 4 sites in Australia, New Zealand and 1 more
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Postmenopausal Osteoporosis
Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis
This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.
- Trial name
- NCT05278338
- Testing
- JMT103, Denosumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai JMT-Bio Inc.
Healthy Volunteers
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of…
- Trial name
- NCT05808673
- Testing
- Post-change CMAB807X, Pre-change CMAB807X, Xgeva®
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Male Subjects
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
- Trial name
- NCT04512872
- Testing
- CT-P41, EU-approved Prolia
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Celltrion
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen