Clinical trials: Denosumab
Osteoporosis
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
- Trial name
- NCT06504966
- Testing
- MAB-22, Prolia®
- Sponsor
- Xentria, Inc.
Postmenopausal Osteoporosis
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women.
- Trial name
- NCT00936897
- Testing
- Ibandronate, Denosumab
- Volunteers
- 833 people
- Sponsor
- Amgen
Healthy Participants
Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
- Trial name
- NCT06310824
- Testing
- MAB-22, EU-Prolia®, US-Prolia®
- Where
- 2 sites in Hungary, Netherlands
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Postmenopausal Osteoporosis
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
- Trial name
- NCT05405725
- Testing
- ENZ215, Prolia
- Where
- 48 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 504 people
- Sponsor
- Enzene Biosciences Ltd.
Low Bone Mineral Density, Postmenopausal Osteoporosis
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low…
- Trial name
- NCT00896532
- Testing
- Alendronate, Teriparatide, Romosozumab
- Volunteers
- 419 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Study of Transitioning From Alendronate to Denosumab
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab.
- Trial name
- NCT00377819
- Testing
- alendronate, Denosumab (AMG 162)
- Volunteers
- 504 people
- Sponsor
- Amgen
Breast Cancer, Prostate Cancer
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.
- Conditions
- Breast Cancer, Prostate Cancer, Bone Neoplasms, Hypocalcemia
- Trial name
- NCT02274623
- Testing
- CTAP101 Capsules
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- OPKO Health, Inc.
GCT, Giant Cell Tumor of Bone
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
- Trial name
- NCT00396279
- Testing
- Denosumab, Calcium/Vitamin D
- Volunteers
- 37 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of…
- Trial name
- NCT01652690
- Testing
- Denosumab
- Where
- 29 sites in Czechia, Slovakia
- Volunteers
- 600 people
- Sponsor
- Amgen
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Non-Small Cell Lung Cancer
Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.
- Trial name
- NCT01951586
- Testing
- Denosumab, Zoledronic acid, Standard Chemotherapy
- Where
- 74 sites in United States, Australia and 8 more
- Volunteers
- 226 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
- Trial name
- NCT04213105
- Testing
- QL1206, Prolia®
- Where
- China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Bone Metastasis From Solid Tumors
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.
- Trial name
- NCT04494373
- Testing
- HS-20090, Xgeva®
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
Bone Metastases From Solid Tumors
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone…
- Trial name
- NCT04859569
- Testing
- LY01011, Xgeva®
- Where
- China
- Volunteers
- 850 people
- Sponsor
- Luye Pharma Group Ltd.
Osteoporosis, Postmenopausal
Comparative Efficacy, Safety, PK, and Immunogenicity Study
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women…
- Trial name
- NCT05853354
- Testing
- Denosumab
- Where
- 39 sites in United States, Bulgaria and 3 more
- Volunteers
- 392 people
- Sponsor
- Luye Pharma Group Ltd.
Healthy Adults
A Study to Evaluate LY06006 and Prolia in Healthy Adults
A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection
- Trial name
- NCT04973722
- Testing
- LY06006, Prolia
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy Male Volunteers
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety…
- Trial name
- NCT04534582
- Testing
- HLX14, EU-Prolia®, US-Prolia®
- Where
- China
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Low Bone Mineral Density, Osteopenia
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
- Conditions
- Low Bone Mineral Density, Osteopenia, Osteoporosis
- Trial name
- NCT00515463
- Testing
- denosumab
- Volunteers
- 311 people
- Sponsor
- Amgen