Clinical trials: Denosumab
Postmenopausal Osteoporosis
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Trial name
- NCT00293813
- Testing
- Alendronate, Denosumab
- Volunteers
- 247 people
- Sponsor
- Amgen
Castrate-resistant Prostate Cancer
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer.
- Trial name
- NCT01824342
- Testing
- Denosumab
- Where
- 9 sites in Czechia, United Kingdom
- Volunteers
- 18 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
Breast Cancer, Hypercalcemia of Malignancy
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering…
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer
- Trial name
- NCT00896454
- Testing
- denosumab
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 33 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
Low Bone Mineral Density, Postmenopausal Osteoporosis
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low…
- Trial name
- NCT00896532
- Testing
- Alendronate, Teriparatide, Romosozumab
- Volunteers
- 419 people
- Sponsor
- Amgen
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
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA
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.
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
- Trial name
- GIOP (NCT01575873)
- Testing
- Denosumab, Risendronate
- Where
- 99 sites in United States, Argentina and 14 more
- Volunteers
- 795 people
- Sponsor
- Amgen
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
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
Cancer, Carcinoma
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity…
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer
- Trial name
- NCT00838201
- Testing
- Denosumab
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 384 people
- Sponsor
- Amgen
Calcium, Osteoporosis
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Using the FREEDOM substudy as a benchmark, evaluate the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, both with and without the combination of Denosumab treatment.
- Conditions
- Calcium, Osteoporosis, Bone Mineral Density, Bone Turnover Marker
- Trial name
- NCT06728462
- Testing
- Amorphous calcium carbonate
- Where
- Taiwan
- Volunteers
- 205 people
- Sponsor
- Universal Integrated Corp.
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
Postmenopausal Osteoporosis, Low Bone Mass
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone…
- Trial name
- NCT07806331
- Testing
- Denosumab
- Volunteers
- 110 people
- Sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
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, Giant Cell Tumors
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)
- Conditions
- Cancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors
- Trial name
- NCT00680992
- Testing
- Denosumab
- Where
- 33 sites in United States, Australia and 10 more
- Volunteers
- 535 people
- Sponsor
- Amgen
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
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