Clinical trials: Denosumab, completed
Renal Impairment
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis
- Trial name
- NCT01464931
- Testing
- Denosumab
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Amgen
Breast Cancer
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.
- Trial name
- NCT00556374
- Testing
- Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid
- Where
- 46 sites in Austria, Sweden
- Volunteers
- 3,420 people
- Sponsor
- Amgen
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
- Trial name
- GIOP (NCT01575873)
- Testing
- Denosumab, Risendronate
- Where
- 99 sites in United States, Argentina and 14 more
- Volunteers
- 795 people
- Sponsor
- Amgen
Erosive Osteoarthritis
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect)…
- Trial name
- NCT04403698
- Testing
- Alendronate Effervescent Oral Tablet
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University Hospital, Ghent
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
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
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
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.
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
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
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
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
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
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
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
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.
- Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
- Trial name
- NCT00104650
- Testing
- AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
- Volunteers
- 111 people
- Sponsor
- Amgen
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
- Trial name
- NCT01419717
- Testing
- Denosumab
- Where
- 64 sites in Argentina, Austria and 17 more
- Volunteers
- 129 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
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