Clinical trials: Denosumab
Healthy Volunteers
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of…
- Trial name
- NCT05808673
- Testing
- Post-change CMAB807X, Pre-change CMAB807X, Xgeva®
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Osteoporosis
Osteoporosis Treatment Protocol in Patients With Fragility Fractures: Application and Efficacy
Osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. Despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of…
- Trial name
- NCT04861142
- Testing
- Anti-osteoporotic medication( alendronate or denosumab)
- Where
- Greece
- Volunteers
- 350 people
- Sponsor
- University General Hospital of Heraklion
Sarcopenia, Osteoporosis
Muscle Impact of Treating Osteoporosis
Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity).
- Trial name
- MITO (NCT05666310)
- Testing
- Denosumab, Zoledronic Acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nami Safai Haeri
Healthy Male Subjects
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
- Trial name
- NCT04512872
- Testing
- CT-P41, EU-approved Prolia
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Celltrion
Osteoporosis
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.
- Trial name
- NCT02130973
- Testing
- Standard Clinical Practice Regimen, Experimental Cyclic Regimen
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Health Research, Inc.
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
Osteoporosis, Postmenopausal
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab
- Trial name
- EURODEC (NCT05575167)
- Testing
- Zoledronate or Alendronate
- Where
- 9 sites in France, Greece and 1 more
- Volunteers
- 122 people
- Sponsor
- 424 General Military Hospital
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA
Osteoporosis, Osteopenia, Renal Transplant Recipient
Alendronate Versus Denosumab in Kidney Transplant Patients
The management of bone disease has often been neglected post-transplantation, when the clinical focus is on allograft function and immunological sequelae.
- Trial name
- NCT04169698
- Testing
- Denosumab 60 mg/ml [Prolia], Alendronate 70Mg Tab
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Ain Shams University
Bone Loss, Aging
Osteoclast Inhibition and Bone Formation
This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab…
- Trial name
- NCT02554695
- Testing
- denosumab
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Osteoporosis
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
- Trial name
- NCT06504966
- Testing
- MAB-22, Prolia®
- Sponsor
- Xentria, Inc.
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
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, Chronic Kidney Disease 5D
Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (HDENOBS)
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: on coronary artery calcification scores evolution after 24 months of followup on abdominal aorta…
- Trial name
- HDENOBS (NCT05234047)
- Testing
- MDCT (multidetector computed tomography), Dual-energy X-ray absorptiometry
- Volunteers
- 21 people
- Sponsor
- University Hospital, Montpellier
Charcot Foot, Diabetes Mellitus
The DENOCHARCOT Trial
The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.
- Trial name
- NCT04547348
- Testing
- Denosumab Injection
- Where
- 8 sites in Denmark
- Volunteers
- 38 people
- Sponsor
- Ole Lander Svendsen
Breast Cancer, Stage IV Breast Cancer
Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases
This is a national multicenter, prospective, randomized controlled trial. The study aims to compare the 5-year overall survival (OS) between patients receiving primary tumor surgery followed by systemic therapy (surgery group)…
- Conditions
- Breast Cancer, Stage IV Breast Cancer, Bone Metastases
- Trial name
- POSITIVE-Bone (NCT07687225)
- Testing
- Primary Tumor Resection, Standard systemic therapy
- Volunteers
- 216 people
- Sponsor
- West China Hospital
Osteoporosis
The Optimal Sequential Therapy After Long Term Denosumab Treatment
This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.
- Trial name
- NCT05091099
- Testing
- zoledronate, Alendronate and Zoledronate
- Where
- Taiwan
- Volunteers
- 44 people
- Sponsor
- National Taiwan University Hospital
Missing Teeth, Implants
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication
Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose > 4 years.
- Conditions
- Missing Teeth, Implants, Cancer, Osteoporosis
- Trial name
- NCT04741906
- Testing
- Dental implant surgery, Prosthetic treatment
- Where
- Denmark
- Volunteers
- 225 people
- Sponsor
- Copenhagen University Hospital at Herlev
Chronic Kidney Diseases, Fracture
Denosumab Treatment in CKD Patients at High Risk of Fracture
Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture.
- Conditions
- Chronic Kidney Diseases, Fracture, Bone Density, Low, End Stage Renal Disease
- Trial name
- NCT05692297
- Testing
- Denosumab, Non-denosumab
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Capital Medical University