Clinical trials: Denosumab
Osteoporosis
Effects of Denosumab Therapy for Japanese
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice.
- Trial name
- NCT02491515
- Testing
- Denosumab
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Tomidahama Hospital
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
Multiple Myeloma
A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
- Trial name
- NCT02833610
- Testing
- Denosumab Q4W
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Massachusetts General Hospital
Osteoporosis
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
- Trial name
- NCT02576652
- Testing
- Tetracycline, Demeclocycline, Total Hip Replacement
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis, Diabetes Type 2
MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.
- Trial name
- NCT03472846
- Testing
- Prolia, 60 Mg/mL Subcutaneous Solution, Teriparatide
- Where
- Austria
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Osteopenia, Lumbar Spondylolisthesis
Denosumab vs Zoledronate After Lumbar Fusion
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire…
- Trial name
- NCT05638399
- Testing
- Denosumab 60 mg/ml [Prolia], Zoledronate
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shenzhen People's Hospital
Postmenopausal Osteoporosis
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Denosumab (Dmab) is a treatment for postmenopausal osteoporosis. However, its withdrawal is associated with a rebound phenomenon associated with an unexpected increased risk of vertebral fractures.
- Trial name
- SAFEST (NCT06767150)
- Testing
- a second infusion of ZOL when crosslaps levels reach 300 pg/mL, a rescue second infusion at month-12 (standard traitment)
- Where
- 17 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Toulouse
Osteoporosis, Postmenopausal
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
- Trial name
- MW031 (NCT04798313)
- Testing
- MW031, Prolia®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Giant Cell Tumor of Bone
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment
The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.
- Trial name
- GCTLIMBS (NCT02996734)
- Testing
- curettage and resection
- Volunteers
- 412 people
- Sponsor
- Istituto Ortopedico Rizzoli
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
Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults
- Trial name
- NCT05777109
- Testing
- HS-20090, Xgeva®
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Osteogenesis Imperfecta
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta.
- Trial name
- OI-AK (NCT01799798)
- Testing
- Denosumab
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- University of Cologne
This is a Phase I Study Conducted in Healthy Volunteers
AVT03 With Xgeva in Healthy Male Subjects
This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old.
- Trial name
- NCT05876949
- Testing
- AVT03, Denosumab
- Where
- 3 sites in Poland, South Africa and 1 more
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
- Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
- Trial name
- NCT00104650
- Testing
- AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
- Volunteers
- 111 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, Bone Mineral Density
The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
- Trial name
- NCT05091086
- Testing
- Continuous Denosumab, Administer zoledronate and denosumab on an alternating schedule
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- National Taiwan University Hospital
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
- Trial name
- NCT01419717
- Testing
- Denosumab
- Where
- 64 sites in Argentina, Austria and 17 more
- Volunteers
- 129 people
- Sponsor
- Amgen
Bone Giant Cell Tumor
Reduced Dose-density of Denosumab for Unresectable GCTB
This study is a multi-center, multi-national, open label, single arm phase 2 study of single-agent denosumab. The objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients…
- Trial name
- REDUCE (NCT03620149)
- Testing
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 2 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Infertility, Male
FITMI - First In Treating Male Infertility
This RCT aims to assess whether treatment with Denosumab can improve semen quality in infertile men selected by serum AMH as a positive predictive biomarker.
- Trial name
- NCT05212337
- Testing
- Denosumab, Sodium chloride
- Where
- Denmark
- Volunteers
- 180 people
- Sponsor
- Martin Blomberg Jensen
Nonalcoholic Fatty Liver, Osteoporosis, Postmenopausal
Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode.
- Trial name
- OsteoNAFLD (NCT05493761)
- Testing
- Denosumab, Alendronate Sodium
- Where
- 3 sites in Greece
- Volunteers
- 72 people
- Sponsor
- Aristotle University Of Thessaloniki