Clinical trials: Denosumab, completed
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
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
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
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
Healthy
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
- Trial name
- NCT04621318
- Testing
- Denosumab
- Where
- 2 sites in United States, France
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
Osteoporosis
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece
This is multiple center, prospective study aiming to investigate the tracking and outcome of patients attending Greek General hospitals with low-trauma fractures.
- Trial name
- NCT02637180
- Testing
- anti-osteoporotic medication
- Where
- 4 sites in Greece
- Volunteers
- 397 people
- Sponsor
- Hellenic Society for the Study of Bone Metabolism
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
Postmenopausal Osteoporosis
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
- Trial name
- NCT01750086
- Testing
- Teriparatide 40-mcg subcutaneous injection, Denosumab Injection, Alendronate Oral Tablet
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Breast Cancer, Prostate Cancer
4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases
The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System.
- Conditions
- Breast Cancer, Prostate Cancer, Metastasis
- Trial name
- REaCT-BTA (NCT02721433)
- Testing
- Pamidronate, Denosumab, Zoledronate
- Where
- Canada
- Volunteers
- 263 people
- Sponsor
- Ottawa Hospital Research Institute
Healthy Volunteers
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
- Trial name
- DENARIUS (NCT05323708)
- Testing
- Bmab 1000, Prolia®
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Healthy Subject
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects
- Trial name
- NCT06037395
- Testing
- CT-P41, US-licensed Prolia
- Where
- 2 sites in South Korea
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Celltrion
Breast Cancer, Metastases
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
- Conditions
- Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
- Trial name
- NCT00091832
- Testing
- Denosumab, IV Bisphosphonates
- Volunteers
- 255 people
- Sponsor
- Amgen