Clinical trials: Denosumab
Osteoporotic Fractures
Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies.
- Trial name
- NCT05866029
- Testing
- Denosumab, Teriparatide
- Where
- 58 sites in China
- Volunteers
- 2,478 people
- Sponsor
- Peking Union Medical College Hospital
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.
Postmenopausal Osteoporosis
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
- Trial name
- NCT05630768
- Testing
- Risedronate Sodium 35 MG [Actonel], Calcium Vitamin D combination
- Where
- South Korea
- Volunteers
- 149 people
- Sponsor
- Dong-A ST Co., Ltd.
Non-Small Cell Lung Cancer
A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.
- Trial name
- NCT07034391
- Testing
- denosumab combined anti-PD-1 inhibitor with chemotherapy
- Where
- China
- Volunteers
- 40 people
- Sponsor
- China Medical University, China
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
Healthy Volunteer, Female, Breast
Effect of Denosumab on Cellular Biomarkers in the Human Breast
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
- Trial name
- NCT02099461
- Testing
- Denosumab, Percutaneous core needle breast biopsy
- Where
- 3 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Amgen
Cancer, Giant Cell Tumors
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)
- Conditions
- Cancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors
- Trial name
- NCT00680992
- Testing
- Denosumab
- Where
- 33 sites in United States, Australia and 10 more
- Volunteers
- 535 people
- Sponsor
- Amgen
Breast Cancer
Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer
The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow.
- Trial name
- NCT02366130
- Testing
- Ra-223 dichloride, Denosumab, Hormone Therapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- M.D. Anderson Cancer Center
Osteoporosis, Fusion of Spine, Lumbar Region
Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a…
- Trial name
- NCT05203588
- Testing
- Denosumab 60 mg/ml Injectable Solution [Prolia], calcium and vitamin D
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Shanghai Changzheng Hospital
Osteogenesis Imperfecta (OI)
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
- Trial name
- NCT03638128
- Testing
- Denosumab, Alternative osteoporosis medications
- Where
- 22 sites in United States, Australia and 10 more
- Volunteers
- 75 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
Disorder Related to Bone Marrow Transplantation
Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children
Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone damages are caused by both a decrease of bone formation and an increase of bone destruction after BMT.For long term survivors, bone…
- Trial name
- NCT02677246
- Testing
- Denosumab
- Where
- Canada
- Sponsor
- St. Justine's Hospital
IOP, Osteoporosis
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP)…
- Trial name
- NCT03396315
- Testing
- Alendronate, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Columbia University
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
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
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
Solid Tumours, Bone Metastasis
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer.
- Trial name
- NCT01998607
- Testing
- Physician Survey
- Volunteers
- 420 people
- Sponsor
- Amgen
Melanoma Stage Iii, Melanoma Stage Iv
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1…
- Conditions
- Melanoma Stage Iii, Melanoma Stage Iv, Melanoma, Melanoma (Skin)
- Trial name
- NCT03620019
- Testing
- Denosumab, Pembrolizumab, Nivolumab
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Cancer, Carcinoma
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity…
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer
- Trial name
- NCT00838201
- Testing
- Denosumab
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 384 people
- Sponsor
- Amgen
Healthy Subject
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
- Trial name
- NCT06037395
- Testing
- CT-P41, US-licensed Prolia
- Where
- 2 sites in South Korea
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Celltrion