Clinical trials: Denosumab
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.
Denosumab Allergy
Denosumab and Screw Fixation for Osteoporotic Compression Fracture
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
- Trial name
- NCT05065164
- Testing
- Denosumab Only Product
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Infertility, Male
NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia
This clinical interventional study aims to assess whether treatment with denosumab in combination with letrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian…
- Trial name
- NT-NOA (NCT06706414)
- Testing
- Denosumab (Prolia), Letrozole (Aromatase Inhibitors)
- Where
- Denmark
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Martin Blomberg Jensen
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.
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
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.
BRCA1 Mutation, Breast Cancer
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an…
- Conditions
- BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms
- Trial name
- BRCA-P (NCT04711109)
- Testing
- Denosumab, Quality-of-Life Assessment
- Where
- 47 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Alliance for Clinical Trials in Oncology
Healthy Volunteers
Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers
This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807…
- Trial name
- NCT06361355
- Testing
- Post-change CMAB807, Prolia
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Osteoarthritis, Osteoarthritis (OA) of the Knee
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
The goal of this clinical trial is to evaluate the skin safety of a soluble denosumab microneedle patch in participants with osteoporosis and osteoarthritis.
- Conditions
- Osteoarthritis, Osteoarthritis (OA) of the Knee, Osteoporosis, Osteoporosis (Senile)
- Trial name
- CSEDSSDMP (NCT07085520)
- Testing
- Microneedle with 0.24mg Denosumab, Saline Microneedle Patch, Microneedle with 1.2mg Denosumab
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.
Osteoporosis, Postmenopausal
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
This randomized open label clinical trial will evaluate the effect of continued denosumab alone over 18 months versus denosumab with added abaloparatide for 18 months.
- Trial name
- NCT04467983
- Testing
- Denosumab Injection, Abaloparatide
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
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 Male Subjects
AVT03 With Prolia in Healthy Male Subjects
This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old.
- Trial name
- NCT05126784
- Testing
- AVT03, Prolia
- Where
- 4 sites in Australia, New Zealand and 1 more
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy Volunteers
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of…
- Trial name
- NCT05808673
- Testing
- Post-change CMAB807X, Pre-change CMAB807X, Xgeva®
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Male Subjects
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
- Trial name
- NCT04512872
- Testing
- CT-P41, EU-approved Prolia
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Celltrion
Osteoporosis
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.
- Trial name
- NCT02130973
- Testing
- Standard Clinical Practice Regimen, Experimental Cyclic Regimen
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Health Research, Inc.
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
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
Healthy Participants
Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®
- Trial name
- NCT06310824
- Testing
- MAB-22, EU-Prolia®, US-Prolia®
- Where
- 2 sites in Hungary, Netherlands
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.