Clinical trials: Denosumab, completed
Colorectal Cancer
A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)
This is a Phase II, open label, multicentre, multi-arm, study to evaluate the preliminary efficacy and safety of RXC004 as monotherapy and in combination with nivolumab in patients with Ring finger protein 43 (RNF43) or R-spondin…
- Trial name
- NCT04907539
- Testing
- RXC004, Nivolumab, Denosumab
- Where
- 22 sites in United States, South Korea and 2 more
- Volunteers
- 25 people
- Sponsor
- Redx Pharma Ltd
Giant Cell Tumor of Bone
A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone
This is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of Chinese populations of surgically unsalvageable or severe post-surgery…
- Trial name
- NCT05402865
- Testing
- Denosumab
- Where
- 3 sites in China
- Volunteers
- 301 people
- Sponsor
- Shanghai JMT-Bio Inc.
Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
- Trial name
- NCT04934072
- Testing
- FKS518, US-licensed Prolia (Amgen)
- Where
- 76 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 553 people
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Giant Cell Tumor of Bone
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
- Trial name
- NCT03301857
- Testing
- Denosumab
- Where
- 14 sites in United States, Australia and 6 more
- Volunteers
- 85 people
- Sponsor
- Amgen
Low Bone Mass, Low Bone Mineral Density
A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
- Trial name
- NCT00887965
- Testing
- Previous denosumab
- Volunteers
- 15 people
- Sponsor
- Amgen
Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced…
- Trial name
- NCT03164928
- Testing
- Denosumab
- Where
- 38 sites in United States, Australia and 11 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Relapsed or Plateau-Phase Multiple Myeloma
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
- Trial name
- NCT00259740
- Testing
- DENOSUMAB
- Volunteers
- 96 people
- Sponsor
- Amgen
Solid Tumours, Bone Metastasis
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer.
- Trial name
- NCT01998607
- Testing
- Physician Survey
- Volunteers
- 420 people
- Sponsor
- Amgen
Low Bone Mass, Low Bone Mineral Density
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Males With Osteoporosis, Osteopenia
- Trial name
- NCT00980174
- Testing
- 60 mg denosumab
- Volunteers
- 242 people
- Sponsor
- Amgen
Cancer, Cataract
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation…
- Conditions
- Cancer, Cataract, Low Bone Mineral Density, Osteopenia
- Trial name
- NCT00925600
- Testing
- Denosumab
- Where
- 172 sites in United States, Australia and 16 more
- Volunteers
- 769 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG
Postmenopausal Osteoporosis
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.
- Trial name
- NCT01221727
- Testing
- Denosumab, Midazolam
- Volunteers
- 30 people
- Sponsor
- Amgen
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.
Breast Cancer
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.
- Trial name
- NCT00556374
- Testing
- Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid
- Where
- 46 sites in Austria, Sweden
- Volunteers
- 3,420 people
- Sponsor
- Amgen
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
Renal Impairment
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis
- Trial name
- NCT01464931
- Testing
- Denosumab
- Where
- 7 sites in United States
- Volunteers
- 32 people
- 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.
Post Menopausal Osteoporosis
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
- Trial name
- PILOTE (NCT02347865)
- Testing
- AMG 162 - Prolia
- Where
- France
- Volunteers
- 777 people
- Sponsor
- Amgen
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
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