Clinical trials: Denosumab, completed
Healthy Volunteers
Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers
This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807…
- Trial name
- NCT06361355
- Testing
- Post-change CMAB807, Prolia
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Testis, Infertility
TNFSF11 Inhibition and Fertility: a Prospective Study
The receptor activator of NF-kB ligand (RANKL) system is considered important for bone homeostasis and comprises three important factors.
- Conditions
- Testis, Infertility, Sperm
- Trial name
- NCT02422108
- Testing
- Denosumab
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Martin Blomberg Jensen
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
Breast Cancer Prevention, Mammographic Density
RANKL Inhibition and Breast Tissue Biomarkers
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be…
- Trial name
- NCT03629717
- Testing
- Ultrasound-guided core needle biopsy, Denosumab, Blood draw
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Prostate Cancer
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
This study will evaluate AMG 162 in the treatment of bone loss in subjects undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer.
- Trial name
- NCT00089674
- Testing
- AMG 162
- Volunteers
- 1,468 people
- Sponsor
- Amgen
Breast Cancer
Denosumab and MRI Breast Imaging
This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently not receiving anticancer treatment with…
- Trial name
- Dmab (NCT02613416)
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Alison Stopeck
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
Phosphorus and Calcium Disorders
Reliability of Serum Calcium to Phosphorus (Ca/P) Ratio as an Accurate and Inexpensive Tool to Define Disorders of Ca-P Metabolism
BACKGROUND: Primary hyperparathyroidism (PHPT) is the third most common endocrine disorder. The Ca/P ratio is an accurate tool to differentiate patients with PHPT (>3.5 if Ca and P are expressed in mg/dl) from healthy subjects.
- Trial name
- NCT03603444
- Testing
- No intervention are provided
- Where
- Italy
- Volunteers
- 606 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
Osteoporosis, Postmenopausal
Denosumab China Phase III Study
This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.
- Trial name
- NCT02014467
- Testing
- Denosumab, Elemental Calcium, Vitamin D
- Where
- 8 sites in China
- Volunteers
- 486 people
- Sponsor
- GlaxoSmithKline
Postmenopausal Osteoporosis
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of…
- Trial name
- NCT03925051
- Testing
- Prolia®, CMAB807
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Osteoporosis, Age-Related
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
- Trial name
- NCT02732210
- Where
- 89 sites in United States, Canada
- Volunteers
- 935 people
- Sponsor
- Amgen
Osteonecrosis of the Jaw, Infection Leading to Hospitalization
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.
- Trial name
- NCT01967160
- Volunteers
- 2,560 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this…
- Trial name
- NCT00091793
- Testing
- AMG 162
- Volunteers
- 332 people
- Sponsor
- Amgen
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
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
Fractures, Bone
A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors
This is a randomized, double-blind, double-dummy study designed to provide bridging data in an Asian population to Amgen's studies of denosumab in subjects with bone metastases from solid tumors.
- Trial name
- NCT01920568
- Testing
- Denosumab 70 mg/mL, Zoledronic acid 4 mg, Calcium supplement
- Where
- 25 sites in China, Singapore and 1 more
- Volunteers
- 487 people
- Sponsor
- GlaxoSmithKline
Healthy Male Subjects
AVT03 With Prolia in Healthy Male Subjects
This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old.
- Trial name
- NCT05126784
- Testing
- AVT03, Prolia
- Where
- 4 sites in Australia, New Zealand and 1 more
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
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
Healthy Male Subjects
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
- Trial name
- NCT04512872
- Testing
- CT-P41, EU-approved Prolia
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Celltrion
Osteoporosis, Postmenopausal
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
- Trial name
- NCT04729621
- Testing
- TVB-009, Prolia®
- Where
- 78 sites in United States, Bulgaria and 8 more
- Volunteers
- 332 people
- Sponsor
- Teva Pharmaceuticals USA