Clinical trials: Denosumab
Osteoporosis, Osteoporosis Fracture
Breast Cancer Women on Aromatase Inhibitors Treatment
The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women.
- Conditions
- Osteoporosis, Osteoporosis Fracture, Arthralgia Generalized
- Trial name
- B-ABLE (NCT03811509)
- Testing
- bisphosphonate
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Parc de Salut Mar
Postmenopausal Women With Osteoporosis at High Risk of Fracture
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
- Trial name
- NCT07062978
- Testing
- QL1206, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Osteoporosis
China HVT Safety, PK, PD
This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China.
- Trial name
- NCT02135640
- Testing
- denosumab 60mg, denosumab 120 mg
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hormone Refractory Prostate Cancer
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis…
- Trial name
- NCT00286091
- Testing
- Denosumab
- Volunteers
- 1,435 people
- Sponsor
- Amgen
Osteoporosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
- Trial name
- NCT00089791
- Testing
- Denosumab
- Volunteers
- 7,808 people
- Sponsor
- Amgen
Giant Cell Tumor of Bone
Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China
This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.All the patients enrolled will take denosumab according to the protocols.We focus on the recurrence…
- Trial name
- NCT03358212
- Testing
- Denosumab
- Volunteers
- 100 people
- Sponsor
- Peking University People's Hospital
Low Bone Mass, Low Bone Mineral Density
A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT).
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
- Trial name
- NCT00890981
- Testing
- high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA), Denosumab
- Volunteers
- 79 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Romosozumab and Denosumab Combination Therapy for Osteoporosis
In this research study, the investigators want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
- Trial name
- NCT07909304
- Testing
- Romosozumab, Romosozumab and Denosumab
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Rheumatoid Arthritis
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.
- Trial name
- DESIRABLE (NCT01973569)
- Testing
- denosumab
- Where
- Japan
- Volunteers
- 679 people
- Sponsor
- Daiichi Sankyo
Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI
Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date.
- Trial name
- Chronic Romo (NCT04232657)
- Testing
- Romosozumab, Denosumab
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- VA Office of Research and Development
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
Osteoporosis, Spinal Cord Injury
Denosumab Administration After Spinal Cord Injury
Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal…
- Trial name
- NCT01983475
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- James J. Peters Veterans Affairs Medical Center
Healthy Volunteer
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1.
- Trial name
- NCT01869686
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amgen
Sarcopenia, Osteoporosis
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group.
- Conditions
- Sarcopenia, Osteoporosis, Denosumab
- Trial name
- NCT06154707
- Testing
- Denosumab Injection, Normal saline injection (1.0ml/ branch)
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Bone Diseases, Pain
Denosumab Treatment for Fibrous Dysplasia
Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD).
- Trial name
- NCT03571191
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
This is a Phase I Study Conducted in Healthy Volunteers
AVT03 With Xgeva in Healthy Male Subjects
This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old.
- Trial name
- NCT05876949
- Testing
- AVT03, Denosumab
- Where
- 3 sites in Poland, South Africa and 1 more
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Osteoporosis
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women
The purpose of this study is to compare the efficacy and safety of Denosumab 60 mg produced by AryoGen Pharmed and Amgen Denosumab 60 mg among osteoporotic postmenopausal women.
- Trial name
- NCT03293108
- Testing
- Denosumab, calcium, vitamin D
- Where
- Iran
- Volunteers
- 190 people
- Sponsor
- AryoGen Pharmed Co.
Bone Tumor
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
- Trial name
- MW032 (NCT04798326)
- Testing
- MW032, Xgeva®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Ultraviolet Rays, Immunosuppression
Effect of RANKL Inhibition on UV-induced Immunosuppression
Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and health. One of the harmful effects of long-term UV light exposure is that it can cause skin cancer.
- Conditions
- Ultraviolet Rays, Immunosuppression, Hypersensitivity, Delayed, Immune Tolerance/Drug Effects
- Trial name
- NCT01978483
- Testing
- Denosumab, UVB exposure, Diphenylcyclopropenone
- Where
- Canada
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Innovaderm Research Inc.