Clinical trials: Denosumab, completed
Hypovitaminosis D, Osteoporosis, Postmenopausal
Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis
Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy.
- Conditions
- Hypovitaminosis D, Osteoporosis, Postmenopausal, Menopause
- Trial name
- NCT05372224
- Testing
- Cholecalciferol
- Where
- Mexico
- Volunteers
- 55 people
- Sponsor
- Hospital Regional 1o de Octubre
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
Cancer, Cataract
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation…
- Conditions
- Cancer, Cataract, Low Bone Mineral Density, Osteopenia
- Trial name
- NCT00925600
- Testing
- Denosumab
- Where
- 172 sites in United States, Australia and 16 more
- Volunteers
- 769 people
- Sponsor
- Amgen
Infertility, Male
NAPO - Novel Approach for Oligospermia
This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely…
- Trial name
- NAPO (NCT06300229)
- Testing
- Denosumab, sodium chloride
- Where
- Denmark
- Volunteers
- 42 people
- Sponsor
- Martin Blomberg Jensen
Infertility, Male
NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia
This clinical interventional study aims to assess whether treatment with denosumab in combination with letrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian…
- Trial name
- NT-NOA (NCT06706414)
- Testing
- Denosumab (Prolia), Letrozole (Aromatase Inhibitors)
- Where
- Denmark
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Martin Blomberg Jensen
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG
Postmenopausal Osteoporosis
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.
- Trial name
- NCT01221727
- Testing
- Denosumab, Midazolam
- Volunteers
- 30 people
- Sponsor
- Amgen
Langerhans Cell Histiocytosis
Denosumab for the Treatment of Adult LCH
This study is aiming to evaluate the efficacy of denosumab among adult patients suffering from Langerhans Cell Histiocytosis (LCH).
- Trial name
- NCT03270020
- Testing
- Denosumab 70 MG/ML [Xgeva]
- Where
- Greece
- Volunteers
- 10 people
- Sponsor
- Hellenic Society for the Study of Bone Metabolism
Osteoporosis
Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study
In the light of current literature data, it is not recommended to discontinue Denosumab therapy without initiating another antiresorptive therapy.
- Trial name
- NCT06414616
- Where
- Turkey (Türkiye)
- Volunteers
- 210 people
- Sponsor
- Trakya University
Multiple Myeloma
A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
- Trial name
- NCT02833610
- Testing
- Denosumab Q4W
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Massachusetts General Hospital
Osteoporosis, Postmenopausal
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
- Trial name
- MW031 (NCT04798313)
- Testing
- MW031, Prolia®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
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, 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
Adult Idiopathic Generalized Osteoporosis
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
- Trial name
- NCT02049866
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- Elizabeth Shane
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
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.
- Trial name
- NCT03651947
- Testing
- QL1206, Xgeva®
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Giant Cell Tumor of Bone
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment
The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.
- Trial name
- GCTLIMBS (NCT02996734)
- Testing
- curettage and resection
- Volunteers
- 412 people
- Sponsor
- Istituto Ortopedico Rizzoli
Post Menopausal Osteoporosis
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
- Trial name
- PILOTE (NCT02347865)
- Testing
- AMG 162 - Prolia
- Where
- France
- Volunteers
- 777 people
- Sponsor
- Amgen
IOP, Osteoporosis
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP)…
- Trial name
- NCT03396315
- Testing
- Alendronate, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Columbia University
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