Clinical trials: Denosumab
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Osteoporosis
Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement
The primary objective of this study is to determine the incidence of modeling-based bone formation in the femoral neck in participants who have received denosumab and are undergoing total hip replacement (THR).
- Trial name
- NCT02576652
- Testing
- Tetracycline, Demeclocycline, Total Hip Replacement
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Amgen
Prostate Cancer
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases
This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.
- Trial name
- NCT02758132
- Testing
- Denosumab, Enzalutamide, Abiraterone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Hawaii
Osteoporosis
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
- Trial name
- NCT03822078
- Testing
- Denosumab
- Volunteers
- 45 people
- Sponsor
- Amgen
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
GCT, Giant Cell Tumor of Bone
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
- Trial name
- NCT00396279
- Testing
- Denosumab, Calcium/Vitamin D
- Volunteers
- 37 people
- Sponsor
- Amgen
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
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
Low Bone Mineral Density, Osteopenia
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).
- Conditions
- Low Bone Mineral Density, Osteopenia, Osteoporosis
- Trial name
- NCT00515463
- Testing
- denosumab
- Volunteers
- 311 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
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
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
Osteopenia, Osteoporosis
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
The primary objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who…
- Trial name
- NCT00523341
- Testing
- Denosumab
- Volunteers
- 4,550 people
- Sponsor
- Amgen
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
Healthy Volunteer, Female, Breast
Effect of Denosumab on Cellular Biomarkers in the Human Breast
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
- Trial name
- NCT02099461
- Testing
- Denosumab, Percutaneous core needle breast biopsy
- Where
- 3 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Amgen
Breast Cancer, Low Bone Mineral Density
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer
The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
- Conditions
- Breast Cancer, Low Bone Mineral Density, Osteopenia
- Trial name
- NCT00089661
- Testing
- AMG 162 / Denosumab
- Volunteers
- 252 people
- Sponsor
- Amgen
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
Breast Cancer
Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast…
- Trial name
- NCT01077154
- Testing
- Denosumab
- Where
- 459 sites in United States, Argentina and 37 more
- Volunteers
- 4,509 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
- Trial name
- NCT04757376
- Testing
- CT-P41, US-licensed Prolia
- Where
- 20 sites in Estonia, Latvia and 2 more
- Volunteers
- 479 people
- Sponsor
- Celltrion
Postmenopausal Osteoporosis
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
- Trial name
- NCT05405725
- Testing
- ENZ215, Prolia
- Where
- 48 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 504 people
- Sponsor
- Enzene Biosciences Ltd.