Clinical trials: Denosumab
Healthy
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
- Trial name
- NCT04621318
- Testing
- Denosumab
- Where
- 2 sites in United States, France
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
Osteoporosis
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece
This is multiple center, prospective study aiming to investigate the tracking and outcome of patients attending Greek General hospitals with low-trauma fractures.
- Trial name
- NCT02637180
- Testing
- anti-osteoporotic medication
- Where
- 4 sites in Greece
- Volunteers
- 397 people
- Sponsor
- Hellenic Society for the Study of Bone Metabolism
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
Premenopausal Idiopathic Osteoporosis
Romosozumab/Denosumab Study for Premenopausal IOP
The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy.
- Trial name
- NCT04800367
- Testing
- Romosozumab Prefilled Syringe [Evenity], Denosumab 60 MG/ML Prefilled Syringe [Prolia]
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Columbia University
For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors.
- Trial name
- NCT07028268
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Postmenopausal Osteoporosis
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
- Trial name
- NCT01750086
- Testing
- Teriparatide 40-mcg subcutaneous injection, Denosumab Injection, Alendronate Oral Tablet
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Osteoporosis
Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis
Osteoporosis is a lifelong chronic condition requiring long-term management. Conventional first-line anti-resorptive therapies often yield slow BMD improvement and may plateau after years of treatment.
- Trial name
- NCT07283887
- Testing
- Denosumab, Romosozumab
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer, Prostate Cancer
4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases
The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System.
- Conditions
- Breast Cancer, Prostate Cancer, Metastasis
- Trial name
- REaCT-BTA (NCT02721433)
- Testing
- Pamidronate, Denosumab, Zoledronate
- Where
- Canada
- Volunteers
- 263 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Cancer
Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer
This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD.
- Trial name
- NCT03324932
- Testing
- Denosumab Injection
- Where
- Japan
- Volunteers
- 160 people
- Sponsor
- Kyoto Prefectural University of Medicine
Healthy Volunteers
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
- Trial name
- DENARIUS (NCT05323708)
- Testing
- Bmab 1000, Prolia®
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
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
Breast Cancer, Metastases
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
- Conditions
- Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
- Trial name
- NCT00091832
- Testing
- Denosumab, IV Bisphosphonates
- Volunteers
- 255 people
- Sponsor
- Amgen
Osteoarthritis, Knee
Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty
This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery.
- Trial name
- NCT05559268
- Testing
- Denosumab 60 MG/ML Injectable Solution [Prolia]
- Volunteers
- 60 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Fibrous Dysplasia, McCune Albright Syndrome
DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)
Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue.
- Trial name
- DeFiD (NCT05966064)
- Testing
- Denosumab 120 Mg/1.7 Ml Inj
- Where
- Netherlands
- Volunteers
- 82 people
- Sponsor
- Natasha Appelman-Dijkstra
Bone Metastases
Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04812509
- Testing
- MW032, Xgeva
- Where
- China
- Volunteers
- 708 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either…
- 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
- NCT00950911
- Testing
- amg 162
- Where
- 17 sites in Czechia, United Kingdom
- Volunteers
- 35 people
- Sponsor
- Amgen
Osteoporosis
The Relationship Between the Residual Renal Function and Osteoporosis Treatment
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.
- Trial name
- NCT02304887
- Testing
- Bis, SERM Teriparatide, Denosumab
- Where
- Japan
- Volunteers
- 1,000 people
- Sponsor
- Toshihiko Kono
Bone Metastases
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04550949
- Testing
- QL1206, Xgeva
- Where
- 2 sites in China
- Volunteers
- 700 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.