Clinical trials: Denosumab
Osteoporotic Vertebral Compression Fracture
Denosumab and Osteoporotic Vertebral Compression Fracture
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture…
- Trial name
- NCT05058443
- Testing
- Denosumab 60 mg/ml [Prolia]
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Denosumab vs Zoledronate
Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial
- Trial name
- NCT05106517
- Testing
- Denosumab, Zoledronic acid
- Where
- China
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
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
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.
Postmenopausal Osteoporosis
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
- Trial name
- NCT04940845
- Testing
- HS-20090-2, Prolia
- Where
- China
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Shanghai Hansoh Biomedical Co., Ltd
Healthy Adults
A Study to Evaluate LY06006 and Prolia in Healthy Adults
A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection
- Trial name
- NCT04973722
- Testing
- LY06006, Prolia
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
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.
Bone Tumor
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
- Trial name
- MW032 (NCT04798326)
- Testing
- MW032, Xgeva®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
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
Osteoporosis, Postmenopausal
Circulating Myokine Levels and Bone Metabolism
Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with…
- Trial name
- NCT04206618
- Testing
- Teriparatide, Denosumab
- Where
- Greece
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- 424 General Military Hospital
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.
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
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.
- Trial name
- NCT02156960
- Testing
- Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients, Denosumab and teriparatide treatment in osteoporotic patients
- Where
- Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Shinshu University
Postmenopausal Osteoporosis
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of…
- Trial name
- NCT03925051
- Testing
- Prolia®, CMAB807
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Bone Metastasis From Solid Tumors
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.
- Trial name
- NCT04494373
- Testing
- HS-20090, Xgeva®
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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.
Healthy Adults
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
- Trial name
- NCT04198636
- Testing
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.
- Trial name
- NCT03651947
- Testing
- QL1206, Xgeva®
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Bone Loss, Aging
Osteoclast Inhibition and Bone Formation
This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab…
- Trial name
- NCT02554695
- Testing
- denosumab
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen