Clinical trials: Denosumab
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, 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 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.
Rheumatoid Arthritis
Effect of Denosumab in Erosion Healing in RA
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
- Trial name
- NCT03239080
- Testing
- Denosumab
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Chinese University of Hong Kong
Postmenopausal Osteoporosis
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women.
- Trial name
- NCT00936897
- Testing
- Ibandronate, Denosumab
- Volunteers
- 833 people
- Sponsor
- Amgen
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, Juvenile Rheumatoid Arthritis
Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in children treated with glucocorticoids for rheumatic disorders.
- Conditions
- Osteoporosis, Juvenile Rheumatoid Arthritis, Dermatomyositis, Polyarthritis
- Trial name
- NCT02418273
- Testing
- denosumab
- Where
- United States
- Sponsor
- Indiana University
Osteoporosis, Osteoporosis, Postmenopausal
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
This two-year observational, open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using…
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal, Osteopenia, Bone Loss
- Trial name
- NCT05405894
- Testing
- Zoledronic acid
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of Calgary
Postmenopausal Osteoporosis
Romosozumab and Denosumab Combination Therapy for Osteoporosis
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Trial name
- NCT07909304
- Testing
- Romosozumab, Romosozumab and Denosumab
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Postmenopausal Osteoporosis
Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis
This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.
- Trial name
- NCT05278338
- Testing
- JMT103, Denosumab
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai JMT-Bio Inc.
Osteoporosis
Contribution of Bone to Urine Citrate
Identification of the mechanisms by which bone contributes to urine citrate could lead to alternative explanations for and approaches to hypocitraturia.
- Trial name
- NCT06811363
- Testing
- Metabolic / prescribed diet, KCit Load (40 meq), Anti-resorptive agents
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Texas Southwestern Medical Center
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
Aneurysmal Bone Cysts, Giant Cell Granuloma
Denosumab in Subjects With Giant Cell Rich Tumors of Bone
An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant…
- Conditions
- Aneurysmal Bone Cysts, Giant Cell Granuloma, Osteoblastoma, Chondroblastoma
- Trial name
- NCT03605199
- Testing
- Denosumab
- Where
- 3 sites in France, Italy and 1 more
- Volunteers
- 60 people
- Sponsor
- Leiden University Medical Center
Dense Breasts
RANKL Inhibition and Mammographic Breast Density
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in…
- Trial name
- TRIDENT (NCT04067726)
- Testing
- Denosumab, Calcium, Vitamin D3
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Washington University School of Medicine
Low Bone Mineral Density
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD.
- Trial name
- NCT00043186
- Testing
- Denosumab, Alendronate
- Volunteers
- 412 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)
The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated…
- Trial name
- NCT05655013
- Testing
- Zoledronate
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Aarhus University Hospital
Smoldering Multiple Myeloma
Denosumab for Smoldering Multiple Myeloma
This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.
- Trial name
- NCT03839459
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Rochester
Osteoporosis
Step-down Therapy After Long-term Osteoporosis Treatment
Maintaining bone mineral density (BMD) after discontinuing denosumab (Prolia) is a major clinical challenge, as rapid bone loss commonly occurs when treatment is stopped, especially after more than three years of use.
- Trial name
- NCT07281586
- Testing
- zoledronate, Denosumab De-escalation
- Where
- Taiwan
- Volunteers
- 44 people
- Sponsor
- National Taiwan University Hospital
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
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.