Clinical trials: Denosumab, completed
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.
Healthy
A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection
This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics…
- Trial name
- NCT06095427
- Testing
- LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia
- Where
- 2 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shandong Boan Biotechnology Co., Ltd
Ultraviolet Rays, Immunosuppression
Effect of RANKL Inhibition on UV-induced Immunosuppression
Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and health. One of the harmful effects of long-term UV light exposure is that it can cause skin cancer.
- Conditions
- Ultraviolet Rays, Immunosuppression, Hypersensitivity, Delayed, Immune Tolerance/Drug Effects
- Trial name
- NCT01978483
- Testing
- Denosumab, UVB exposure, Diphenylcyclopropenone
- Where
- Canada
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Innovaderm Research Inc.
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.
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
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
Postmenopausal Osteoporosis
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.
- Trial name
- NCT04026256
- Testing
- Teriparatide, Denosumab
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
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
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
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
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 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.
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.
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.
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
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
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
Healthy Volunteer
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1.
- Trial name
- NCT01869686
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amgen