Clinical trials: Denosumab
Breast Cancer
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab.
- Trial name
- NCT05590949
- Testing
- Physical Evaluation, Dual-energy X-ray absorptiometry scans, Trabecular Bone Score
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Lung Cancer
An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting
The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced…
- Trial name
- NCT06749886
- Testing
- Denosumab, tislelizumab, Docetaxel
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Osteoporosis
A Clinical Trial to Evaluate Efficacy of Once or Twice ZOledronic Acid After Different Duration of denOsumMab Administration in Postmenopausal Women With Osteoporosis (ZOOM Study)
Denosumab(Dmab) is a monoclonal antibody that inhibits the receptor-activator of nuclear factor kappa-B ligand. It improves bone density and reduces fractures by inhibiting osteoclast recruitment and differentiation.
- Trial name
- NCT05361408
- Testing
- Zoledronic acid, once, Zoledronic acid, twice
- Where
- South Korea
- Volunteers
- 114 people
- Sponsor
- Yonsei University
Rheumatoid Arthritis
RA Denosumab on Bone Microstructure Study
The aim of this study is to compare the effects of denosumab and a current standard treatment on cortical and trabecular microarchitecture at the radius and second metacarpal in rheumatoid arthritis (RA) patients with low bone…
- Trial name
- NCT01770106
- Testing
- Denosumab, Alendronate
- Where
- Hong Kong
- Volunteers
- 40 people
- Sponsor
- Chinese University of Hong Kong
Arthroplasty, Replacement, Hip
Longjohn Amgen Study - Effect of Denosumab...
The overall objective of the proposed study is to quantify bone loss around non-cemented total hip replacement femoral and acetabular components using DEXA analysis in patients receiving Prolia (denosumab) in the first year of…
- Trial name
- EDRPBLFHR (NCT02444585)
- Testing
- Denosumab
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Southern California
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
Primary Hyperparathyroidism, Osteoporosis
Osteoporosis in Primary Hyperparathyroidism
Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery.
- Trial name
- NCT04085419
- Testing
- Denosumab 60 MG/ML Prefilled Syringe [Prolia], Zoledronic Acid
- Where
- Slovenia
- Volunteers
- 40 people
- Sponsor
- University Medical Centre Ljubljana
Osteoporosis, Osteoporosis Postmenopausal
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a…
- Trial name
- NCT06938152
- Testing
- Romosozumab followed by Denosumab, Romosozumab and Denosumab Cycle Therapy
- Where
- Taiwan
- Volunteers
- 70 people
- Sponsor
- National Taiwan University Hospital
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
Calcific Aortic Stenosis
Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.
Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure and sudden death.
- Trial name
- SALTIRE II (NCT02132026)
- Testing
- Denosumab, Alendronic Acid
- Where
- United Kingdom
- Volunteers
- 152 people
- Sponsor
- University of Edinburgh
Multiple Myeloma
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
This is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and decrease in myeloma growth promotion, reduce the…
- Trial name
- DEFENCE (NCT03792763)
- Testing
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 8 people
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
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
Osteolysis
Denosumab for Treating Periprosthetic Osteolysis.
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty.
- Trial name
- NCT02299817
- Testing
- Denosumab
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Olof Skoldenberg
Postmenopausal Osteoporosis
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide.
- Trial name
- DATA-HD (NCT02176382)
- Testing
- denosumab, teriparatide, Zoledronic acid
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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.
Osteoporosis, Osteopenia, Osteoporosis
Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
This is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different…
- Trial name
- NCT04719572
- Testing
- Basic treatment group, Basic treatment+ anti-osteoporosis drug group, Basic treatment + non-drug treatment group
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Chinese PLA General Hospital
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.
Medication-related Osteonecrosis of the Jaw (MRONJ)
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion.
- Trial name
- NCT07691892
- Volunteers
- 310 people
- Sponsor
- Hospital of Stomatology, Wuhan University
Knee Osteoarthritis
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
This study evaluates how acute mechanical loading affects cartilage degradation biomarkers in postmenopausal women with mild-to-moderate knee osteoarthritis.
- Trial name
- NCT07881861
- Where
- Turkey (Türkiye)
- Volunteers
- 105 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Crohn Disease
The Efficacy of Denosumab in Active Crohn's Disease
Denosumab, a fully human monoclonal antibody to RANKL was approved for the treatment of postmenopausal osteoporosis in June 2010.
- Trial name
- NCT02321280
- Testing
- Denosumab
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- University of Manitoba