Clinical trials: Denosumab
Nonalcoholic Fatty Liver, Osteoporosis, Postmenopausal
Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode.
- Trial name
- OsteoNAFLD (NCT05493761)
- Testing
- Denosumab, Alendronate Sodium
- Where
- 3 sites in Greece
- Volunteers
- 72 people
- Sponsor
- Aristotle University Of Thessaloniki
Osteoporosis, Postmenopausal, Osteoporosis
Preventing Osteoporosis Using Denosumab
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and…
- Conditions
- Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
- Trial name
- PROUD (NCT02753283)
- Testing
- denosumab, Calcium and Vitamin D
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Susan L. Greenspan
Osteoporosis, Postmenopausal
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General…
- Trial name
- NCT05419427
- Testing
- Denosumab, Denosumab-Ref
- Where
- India
- Volunteers
- 552 people
- Sponsor
- Lambda Therapeutic Research Ltd.
Osteoporotic Fracture
Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis
Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures.
- Trial name
- NCT02239523
- Testing
- Letter Group, Intervention Group
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Shaare Zedek Medical Center
Osteoporosis
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts.
- Trial name
- ZOLARMAB (NCT03087851)
- Testing
- Zoledronic Acid
- Where
- Denmark
- Volunteers
- 61 people
- Sponsor
- Aarhus University Hospital
Female With Osteoporosis and Chronic Kidney Disease
Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: on bone mineral density (femoral T-score) at 24 months on bone mineral density evolution (femoral…
- Trial name
- HDENO (NCT02792413)
- Testing
- Denosumab
- Where
- 9 sites in France
- Volunteers
- 4 people
- Sponsor
- University Hospital, Montpellier
Osteoporosis
Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who…
- Trial name
- NCT04177940
- Testing
- DMAB Discontinuation and Switching
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of Alabama at Birmingham
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
- 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
- NCT00104650
- Testing
- AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
- Volunteers
- 111 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.
Erosive Osteoarthritis
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect)…
- Trial name
- NCT04403698
- Testing
- Alendronate Effervescent Oral Tablet
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University Hospital, Ghent
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
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
Healthy Adults
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
- Trial name
- NCT04198636
- Testing
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Osteoporosis in Post-menopausal Women
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis is associated with a high risk of fractures, disability, loss of independence, and excess mortality. Zoledronic acid is an established first-line treatment in Sweden, but many patients at high fracture risk remain at…
- Trial name
- STRONG-HIP (NCT07772609)
- Testing
- Romosozumab, Zoledronic Acid 5 MG in 5 ML Injection, Calcium 500 mg and Vitamin D3 800 IU
- Where
- 9 sites in Sweden
- Volunteers
- 216 people
- Sponsor
- Sahlgrenska University Hospital
Primary Hyperparathyroidism, Parathyroid Adenoma
Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.
The only known cure for primary hyperparathyroidism is surgical removal of one or more parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want to undergo a procedure due to fear of the…
- Conditions
- Primary Hyperparathyroidism, Parathyroid Adenoma, Parathyroid Hyperplasia
- Trial name
- DENOCINA (NCT03027557)
- Testing
- Cinacalcet 30 mg Tablet, Denosumab Inj 60 mg/ml
- Where
- Denmark
- Volunteers
- 46 people
- Sponsor
- Peter Vestergaard
Osseointegrated Implants, Bone Mineral Density
Osseointegrated Transdermal Femoral Amputation Prostheses
Femur amputated patients often suffer from several problems with conventional socket prosthesis. Some experience changes in gait, discomfort when sitting, altered skin conditions (infection, irritation, rashes, sweat), phantom…
- Trial name
- NCT05736640
- Testing
- Denosumab
- Volunteers
- 6 people
- Sponsor
- University of Aarhus
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
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
Metastatic Breast Cancer, Metastatic Prostate Cancer
Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks
The aim of the trial is to test the hypothesis that the benefit of denosumab is maintained if administered only every 12 weeks as compared to every 4 weeks.
- Conditions
- Metastatic Breast Cancer, Metastatic Prostate Cancer, Bone Metastases
- Trial name
- NCT02051218
- Testing
- Denosumab (reduced dosing), Denosumab (standard dosing)
- Where
- 50 sites in Austria, Germany and 1 more
- Volunteers
- 1,380 people
- Sponsor
- Swiss Cancer Institute
Infertility, Male
FITMI - First In Treating Male Infertility
This RCT aims to assess whether treatment with Denosumab can improve semen quality in infertile men selected by serum AMH as a positive predictive biomarker.
- Trial name
- NCT05212337
- Testing
- Denosumab, Sodium chloride
- Where
- Denmark
- Volunteers
- 180 people
- Sponsor
- Martin Blomberg Jensen