Clinical trials: Denosumab
Breast Cancer
Denosumab for Breast Cancer With Bone Mets
The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone.
- Trial name
- NCT01952054
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- M.D. Anderson Cancer Center
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
Melanoma Stage Iv, Melanoma Stage Iii
Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma
The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma.
- Conditions
- Melanoma Stage Iv, Melanoma Stage Iii, Melanoma
- Trial name
- CHARLI (NCT03161756)
- Testing
- Denosumab, Nivolumab, Ipilimumab
- Where
- 10 sites in Australia
- Volunteers
- 72 people
- Sponsor
- Melanoma and Skin Cancer Trials Limited
Type 2 Diabetes, Osteoporosis
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with…
- Conditions
- Type 2 Diabetes, Osteoporosis, Fractures
- Trial name
- NCT07063797
- Testing
- Denosumab treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients, Denosumab combined with eldecalcitol treatment in type 2 diabetes mellitus (T2DM) with osteoporosis patients
- Where
- 4 sites in China
- Volunteers
- 358 people
- Sponsor
- Peking Union Medical College Hospital
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
Bone Resorption
The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
- Trial name
- NCT02760979
- Testing
- Denosumab
- Volunteers
- 60 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Metastatic Breast Cancer
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer.
- Trial name
- NCT06076772
- Testing
- Palbociclib
- Where
- Saudi Arabia
- Volunteers
- 54 people
- Sponsor
- Assiut University
Bone Cyst Aneurysmal, Pathological Fracture
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts
The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in axial skeletons and adolescents complicated…
- Conditions
- Bone Cyst Aneurysmal, Pathological Fracture, Recurrent Disease, Refractory Tumor
- Trial name
- Deno-ABC (NCT03415477)
- Testing
- Denosumab (Xgeva)
- Volunteers
- 6 people
- Sponsor
- Peking University People's Hospital
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
Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study
The aim of this study is to acquire preliminary, pilot data over a 2-year period on the safety and efficacy of subcutaneous denosumab versus the current CHEO standard-of-care (intravenous zoledronic acid) for the treatment of…
- Trial name
- NCT02632916
- Testing
- Zoledronic Acid, Denosumab
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Eastern Ontario
Dense Breasts
RANKL Inhibition and Mammographic Breast Density
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in…
- Trial name
- TRIDENT (NCT04067726)
- Testing
- Denosumab, Calcium, Vitamin D3
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Washington University School of Medicine
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
Prostate Cancer
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases
This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.
- Trial name
- NCT02758132
- Testing
- Denosumab, Enzalutamide, Abiraterone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Hawaii
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.
Osteoporosis, Postmenopausal Osteoporosis
AGE Burden and Response to Antiresorptive Therapy in Osteoporosis
Osteoporosis is a common condition that increases the risk of bone fractures. Although antiresorptive treatments such as bisphosphonates and denosumab are effective in increasing bone mineral density, some patients continue to…
- Trial name
- NCT07329543
- Volunteers
- 240 people
- Sponsor
- Bursa City Hospital
Giant Cell Tumor of Bone
A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone
This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone…
- Trial name
- NCT05813665
- Testing
- Narlumosbart, Denosumab
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shanghai JMT-Bio Inc.
Postmenopausal Osteoporosis
Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation
Discontinuation of denosumab results in a rebound response of bone turnover markers, which rise above baseline at 3 months and remain elevated until reaching again baseline levels approximately 30 months after the last dose.
- Trial name
- BAD (NCT04338529)
- Testing
- Binosto 70Mg Effervescent Tablet
- Where
- Greece
- Volunteers
- 92 people
- Sponsor
- 251 Hellenic Air Force & VA General Hospital
Early Stage Breast Cancer
Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer
The purpose of this study is to see whether taking denosumab for 12 months in women with a significant number of disseminated tumor cells in the bone marrow can reduce the number of these cells below a significant level.
- Trial name
- NCT01545648
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Hope Rugo, MD
Osteoporosis in Post-menopausal Women
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is…
- Trial name
- MORD (NCT06720350)
- Testing
- Romosozumab and Denosumab Combination Therapy, Romosozumab Prefilled Syringe [Evenity], Denosumab (Prolia)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Marmara University