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
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Breast Cancer, Castration-resistant Prostate Cancer
Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer
The investigators propose to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA…
- Trial name
- NCT04549207
- Testing
- Bone modifying agent
- Where
- 5 sites in Canada
- Volunteers
- 240 people
- Sponsor
- Ottawa Hospital Research Institute
Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Osteopenia
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Osteopenia, Osteoporosis
- Trial name
- NCT03925532
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Roswell Park Cancer Institute
Bone Metastases
To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04550949
- Testing
- QL1206, Xgeva
- Where
- 2 sites in China
- Volunteers
- 700 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Postmenopausal, Osteopenia
Effects of Denosumab on the Pharmacokinetics of Etanercept
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis…
- Conditions
- Postmenopausal, Osteopenia, Rheumatoid Arthritis, Osteoporosis
- Trial name
- NCT01294397
- Testing
- Etanercept, Denosumab
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Amgen
Secondary Osteoporosis, Spinal Cord Injury
The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury
The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI.
- Trial name
- NCT03029442
- Testing
- Denosumab (Prolia)
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- James J. Peters Veterans Affairs Medical Center
Breast Cancer
Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer
This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD.
- Trial name
- NCT03324932
- Testing
- Denosumab Injection
- Where
- Japan
- Volunteers
- 160 people
- Sponsor
- Kyoto Prefectural University of Medicine
Osteoporosis in Post-menopausal Women
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis is associated with a high risk of fractures, disability, loss of independence, and excess mortality. Zoledronic acid is an established first-line treatment in Sweden, but many patients at high fracture risk remain at…
- Trial name
- STRONG-HIP (NCT07772609)
- Testing
- Romosozumab, Zoledronic Acid 5 MG in 5 ML Injection, Calcium 500 mg and Vitamin D3 800 IU
- Where
- 9 sites in Sweden
- Volunteers
- 216 people
- Sponsor
- Sahlgrenska University Hospital
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.
Atypical Femur Fracture
Quebec Registry for Atypical Femur Fractures
Bisphosphonates are recommended as first-line agents to reduce fracture risk in patients with osteoporosis and have in general an excellent safety profile.
- Trial name
- NCT02150850
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- McGill University
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
Arthroplasty, Replacement, Hip
Longjohn Amgen Study - Effect of Denosumab...
The overall objective of the proposed study is to quantify bone loss around non-cemented total hip replacement femoral and acetabular components using DEXA analysis in patients receiving Prolia (denosumab) in the first year of…
- Trial name
- EDRPBLFHR (NCT02444585)
- Testing
- Denosumab
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Southern California
Osteoporosis
Denosumab Adherence Preference Satisfaction Study
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12…
- Trial name
- NCT00518531
- Testing
- alendronate, denosumab
- Volunteers
- 250 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
- Trial name
- NCT04591275
- Testing
- CMAB807 Injection, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Denosumab vs Zoledronate
Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture
Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial
- Trial name
- NCT05106517
- Testing
- Denosumab, Zoledronic acid
- Where
- China
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Low Bone Mass, Low Bone Mineral Density
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Males With Osteoporosis, Osteopenia
- Trial name
- NCT00980174
- Testing
- 60 mg denosumab
- Volunteers
- 242 people
- Sponsor
- Amgen
Osteoporosis in Post-menopausal Women
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is…
- Trial name
- MORD (NCT06720350)
- Testing
- Romosozumab and Denosumab Combination Therapy, Romosozumab Prefilled Syringe [Evenity], Denosumab (Prolia)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Marmara University
Relapsed or Plateau-Phase Multiple Myeloma
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
- Trial name
- NCT00259740
- Testing
- DENOSUMAB
- Volunteers
- 96 people
- Sponsor
- Amgen
Multiple Myeloma
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
This is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and decrease in myeloma growth promotion, reduce the…
- Trial name
- DEFENCE (NCT03792763)
- Testing
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Where
- 10 sites in Austria, Germany and 1 more
- Volunteers
- 8 people
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie