Clinical trials: Denosumab
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.
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
Giant Cell Tumor of Bone
Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone
The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).
- Trial name
- NCT04586660
- Testing
- XGEVA®
- Where
- 10 sites in China, Taiwan
- Volunteers
- 36 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
- Trial name
- NCT00321620
- Testing
- zoledronic acid, denosumab
- Volunteers
- 1,904 people
- Sponsor
- Amgen
Osteoporosis
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
- Trial name
- NCT02576652
- Testing
- Tetracycline, Demeclocycline, Total Hip Replacement
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Amgen
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
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
Osteoporosis, Postmenopausal
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
- Trial name
- NCT01495000
- Testing
- denosumab
- Where
- 11 sites in India
- Volunteers
- 250 people
- Sponsor
- GlaxoSmithKline