Clinical trials: Denosumab, completed
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Bone and Joint Infection, Osteomyelitis
Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.
- Conditions
- Bone and Joint Infection, Osteomyelitis, Adverse Drug Event
- Trial name
- NCT03808285
- Testing
- mandibular osteomylitis
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Hospices Civils de Lyon
Post Menopausal Osteoporosis
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
- Trial name
- NCT01732770
- Testing
- Denosumab, Zoledronic Acid
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 643 people
- Sponsor
- Amgen
Osteoporosis
China HVT Safety, PK, PD
This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China.
- Trial name
- NCT02135640
- Testing
- denosumab 60mg, denosumab 120 mg
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hormone Refractory Prostate Cancer
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis…
- Trial name
- NCT00286091
- Testing
- Denosumab
- Volunteers
- 1,435 people
- Sponsor
- Amgen
Osteoporosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
- Trial name
- NCT00089791
- Testing
- Denosumab
- Volunteers
- 7,808 people
- Sponsor
- Amgen
Low Bone Mass, Low Bone Mineral Density
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT).
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
- Trial name
- NCT00890981
- Testing
- high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA), Denosumab
- Volunteers
- 79 people
- Sponsor
- Amgen
Rheumatoid Arthritis
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.
- Trial name
- DESIRABLE (NCT01973569)
- Testing
- denosumab
- Where
- Japan
- Volunteers
- 679 people
- Sponsor
- Daiichi Sankyo
Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI
Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date.
- Trial name
- Chronic Romo (NCT04232657)
- Testing
- Romosozumab, Denosumab
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- VA Office of Research and Development
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
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
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 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.
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
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
- Trial name
- NCT04591275
- Testing
- CMAB807 Injection, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Postmenopausal Osteoporosis
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year
- Trial name
- NCT05630768
- Testing
- Risedronate Sodium 35 MG [Actonel], Calcium Vitamin D combination
- Where
- South Korea
- Volunteers
- 149 people
- Sponsor
- Dong-A ST Co., Ltd.
Postmenopausal Osteoporosis
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
- Trial name
- NCT04664959
- Testing
- SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab)
- Where
- 5 sites in Poland
- Volunteers
- 457 people
- Sponsor
- Samsung Bioepis Co., Ltd.
XGEVA Off-label Use
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen.
- Trial name
- NCT02066805
- Testing
- Database assessment of off-label XGEVA use
- Volunteers
- 142 people
- Sponsor
- Amgen
Osteoporosis
Denosumab Adherence Preference Satisfaction Study
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12…
- Trial name
- NCT00518531
- Testing
- alendronate, denosumab
- Volunteers
- 250 people
- Sponsor
- Amgen
Hand Osteoarthritis
RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints
This is a randomized, double blind placebo controlled one-site proof-of-concept study in subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.
- Trial name
- NCT02771860
- Testing
- denosumab, Calcium/Vit D supplementation
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University Hospital, Ghent