Clinical trials: Denosumab
Charcot Joint of Foot
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy.
- Trial name
- NCT03174366
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Western University of Health Sciences
Non-Small Cell Lung Cancer
Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.
- Trial name
- NCT01951586
- Testing
- Denosumab, Zoledronic acid, Standard Chemotherapy
- Where
- 74 sites in United States, Australia and 8 more
- Volunteers
- 226 people
- Sponsor
- Amgen
Low Bone Mineral Density
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
- Trial name
- NCT00325468
- Testing
- AMG 162
- Volunteers
- 200 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
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
IOP, Osteoporosis
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP)…
- Trial name
- NCT03396315
- Testing
- Alendronate, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Columbia University
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
- Trial name
- NCT01419717
- Testing
- Denosumab
- Where
- 64 sites in Argentina, Austria and 17 more
- Volunteers
- 129 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
Bone Density, Bone Loss
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa.
- Conditions
- Bone Density, Bone Loss, Anorexia Nervosa, Eating Disorder
- Trial name
- NCT03292146
- Testing
- Denosumab 60 MG [Prolia], Alendronate 70Mg Tab
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Massachusetts General Hospital
Postmenopausal Osteoporosis
Study of Transitioning From Alendronate to Denosumab
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab.
- Trial name
- NCT00377819
- Testing
- alendronate, Denosumab (AMG 162)
- Volunteers
- 504 people
- Sponsor
- Amgen
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
Postmenopausal, Osteopenia
Effects of Denosumab on the Pharmacokinetics of Etanercept
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis…
- Conditions
- Postmenopausal, Osteopenia, Rheumatoid Arthritis, Osteoporosis
- Trial name
- NCT01294397
- Testing
- Etanercept, Denosumab
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
- Trial name
- NCT02157948
- Testing
- Denosumab (CP2), Denosumab (CP4)
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 394 people
- Sponsor
- Amgen
Adult Idiopathic Generalized Osteoporosis
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
- Trial name
- NCT02049866
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- Elizabeth Shane
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
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
Advanced Solid Tumours
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.
- Trial name
- KEYNOTE-E86 (NCT04907851)
- Testing
- RXC004, Denosumab, pembrolizumab
- Where
- 13 sites in Australia, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Redx Pharma Ltd
Breast Cancer
Denosumab for Breast Cancer With Bone Mets
The goal of this clinical research study is to learn if denosumab in combination with a hormonal drug can help lower the number of circulating tumor cells (CTCs) in patients with breast cancer that has spread to the bone.
- Trial name
- NCT01952054
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- M.D. Anderson Cancer Center
Melanoma Stage Iii, Melanoma Stage Iv
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
This is a multicenter open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with an anti-Programmed death-1 or Programmed death ligand 1…
- Conditions
- Melanoma Stage Iii, Melanoma Stage Iv, Melanoma, Melanoma (Skin)
- Trial name
- NCT03620019
- Testing
- Denosumab, Pembrolizumab, Nivolumab
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Bariatric Surgery Candidate, Bone Loss
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG)…
- Trial name
- NCT04087096
- Testing
- Denosumab, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Massachusetts General Hospital