Clinical trials: Denosumab
Primary Hyperparathyroidism
Denosumab in Primary Hyperparathyroidism
Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen most often in postmenopausal women.
- Trial name
- NCT01558115
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
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
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
- Trial name
- FRAME (NCT01575834)
- Testing
- Romosozumab, Denosumab
- Where
- 218 sites in United States, Argentina and 22 more
- Volunteers
- 7,180 people
- Sponsor
- Amgen
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
Metastatic Osteosarcoma, Recurrent Osteosarcoma
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).
- Conditions
- Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7
- Trial name
- NCT02470091
- Testing
- Denosumab, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 141 sites in United States, Canada and 1 more
- Volunteers
- 56 people
- Sponsor
- Children's Oncology Group
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
- Trial name
- NCT00321620
- Testing
- zoledronic acid, denosumab
- Volunteers
- 1,904 people
- Sponsor
- Amgen
Osteoporosis, Bone Fracture
Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index
The purpose of this study is to validate the long-term benefit of denosumab for osteoporosis treatment in a real-world clinical practice setting.
- Trial name
- NCT02435147
- Testing
- denosumab
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- HealthEast Care System
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
Dense Breasts
RANKL Inhibition and Mammographic Breast Density
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in…
- Trial name
- TRIDENT (NCT04067726)
- Testing
- Denosumab, Calcium, Vitamin D3
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Washington University School of Medicine
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
Postmenopausal Osteoporosis
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Trial name
- NCT00293813
- Testing
- Alendronate, Denosumab
- Volunteers
- 247 people
- Sponsor
- Amgen
Breast Cancer, Metastases
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
- Conditions
- Breast Cancer, Metastases, Bone Metastases in Subjects With Advanced Breast Cancer
- Trial name
- NCT00091832
- Testing
- Denosumab, IV Bisphosphonates
- Volunteers
- 255 people
- Sponsor
- Amgen
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
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
Osteoporosis, Postmenopausal
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
- Trial name
- NCT01495000
- Testing
- denosumab
- Where
- 11 sites in India
- Volunteers
- 250 people
- Sponsor
- GlaxoSmithKline
Breast Cancer, Hypercalcemia of Malignancy
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering…
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer
- Trial name
- NCT00896454
- Testing
- denosumab
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 33 people
- Sponsor
- Amgen
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count
Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
The purpose of this study is to look at the amount of cancer cells in the blood of participants who are being treated with denosumab.
- Conditions
- Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT03070002
- Testing
- Denosumab, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
Cancer, Carcinoma
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity…
- Conditions
- Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer
- Trial name
- NCT00838201
- Testing
- Denosumab
- Where
- 74 sites in United States, Canada and 4 more
- Volunteers
- 384 people
- Sponsor
- Amgen