Clinical trials: Denosumab
Osteoporosis in Postmenopausal Women
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
Primary objective: To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.
- Trial name
- ESCORT (NCT05884372)
- Testing
- Eldecalcitol, Native Vitamin D, Denosumab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xi'an Honghui Hospital
Giant Cell Tumor of Bone
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment
The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.
- Trial name
- GCTLIMBS (NCT02996734)
- Testing
- curettage and resection
- Volunteers
- 412 people
- Sponsor
- Istituto Ortopedico Rizzoli
Osteogenesis Imperfecta
Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis imperfecta.
- Trial name
- OI-AK (NCT01799798)
- Testing
- Denosumab
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- University of Cologne
Primary Hyperparathyroidism, Osteoporosis
Osteoporosis in Primary Hyperparathyroidism
Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery.
- Trial name
- NCT04085419
- Testing
- Denosumab 60 MG/ML Prefilled Syringe [Prolia], Zoledronic Acid
- Where
- Slovenia
- Volunteers
- 40 people
- Sponsor
- University Medical Centre Ljubljana
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
Osteogenesis Imperfecta (OI)
Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).
- Trial name
- NCT03638128
- Testing
- Denosumab, Alternative osteoporosis medications
- Where
- 22 sites in United States, Australia and 10 more
- Volunteers
- 75 people
- Sponsor
- Amgen
Disorder Related to Bone Marrow Transplantation
Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children
Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone damages are caused by both a decrease of bone formation and an increase of bone destruction after BMT.For long term survivors, bone…
- Trial name
- NCT02677246
- Testing
- Denosumab
- Where
- Canada
- Sponsor
- St. Justine's Hospital
Solid Tumours, Bone Metastasis
Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer.
- Trial name
- NCT01998607
- Testing
- Physician Survey
- Volunteers
- 420 people
- Sponsor
- Amgen
Osteoporosis, Juvenile Rheumatoid Arthritis
Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in children treated with glucocorticoids for rheumatic disorders.
- Conditions
- Osteoporosis, Juvenile Rheumatoid Arthritis, Dermatomyositis, Polyarthritis
- Trial name
- NCT02418273
- Testing
- denosumab
- Where
- United States
- Sponsor
- Indiana University
Osteoporosis, Osteoporosis, Postmenopausal
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
This two-year observational, open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using…
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal, Osteopenia, Bone Loss
- Trial name
- NCT05405894
- Testing
- Zoledronic acid
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of Calgary
Low Bone Mineral Density
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD.
- Trial name
- NCT00043186
- Testing
- Denosumab, Alendronate
- Volunteers
- 412 people
- Sponsor
- Amgen
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen
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
Osteonecrosis Due to Drugs, Jaw
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction
The aim of this trial is to evaluate high-dose antiresorptive drug holiday related to tooth extraction with primary mucosal closure (surgical extraction) including how a drug holiday affects the health related quality of life.
- Trial name
- DrugHoliday (NCT04540601)
- Testing
- Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)
- Where
- 2 sites in Denmark
- Volunteers
- 30 people
- Sponsor
- University of Copenhagen
Osteoporosis
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.
- Trial name
- NCT02156960
- Testing
- Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients, Denosumab and teriparatide treatment in osteoporotic patients
- Where
- Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Shinshu University
Osteoporosis, Age-Related
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
- Trial name
- NCT02732210
- Where
- 89 sites in United States, Canada
- Volunteers
- 935 people
- Sponsor
- Amgen
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
Postmenopausal Osteoporosis
Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
The main objective of this observational study was to describe medication-taking behavior of patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
- Trial name
- NCT01668589
- Where
- 144 sites in Austria, Belgium and 2 more
- Volunteers
- 1,501 people
- Sponsor
- Amgen
Osteoporosis
Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study
In the light of current literature data, it is not recommended to discontinue Denosumab therapy without initiating another antiresorptive therapy.
- Trial name
- NCT06414616
- Where
- Turkey (Türkiye)
- Volunteers
- 210 people
- Sponsor
- Trakya University
Giant Cell Tumor of Bone
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
- Trial name
- NCT03301857
- Testing
- Denosumab
- Where
- 14 sites in United States, Australia and 6 more
- Volunteers
- 85 people
- Sponsor
- Amgen