Clinical trials: Denosumab, completed
Breast Cancer
Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer
The goal of this clinical research study is to learn if Xofigo® (also called Ra-223 dichloride) combined with hormone therapy and denosumab can help to control breast cancer that has spread to the bones and/or bone marrow.
- Trial name
- NCT02366130
- Testing
- Ra-223 dichloride, Denosumab, Hormone Therapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer Female NOS, Tubular Breast Cancer Stage II
Denosumab as an add-on Neoadjuvant Treatment (GeparX)
Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models.
- Conditions
- Breast Cancer Female NOS, Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Invasive Ductal Breast Cancer
- Trial name
- GeparX (NCT02682693)
- Testing
- Denosumab, nab-Paclitaxel, Epirubicin
- Where
- Germany
- Volunteers
- 780 people
- Sponsor
- GBG Forschungs GmbH
Osteoporosis
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in Greece
This is multiple center, prospective study aiming to investigate the tracking and outcome of patients attending Greek General hospitals with low-trauma fractures.
- Trial name
- NCT02637180
- Testing
- anti-osteoporotic medication
- Where
- 4 sites in Greece
- Volunteers
- 397 people
- Sponsor
- Hellenic Society for the Study of Bone Metabolism
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
Osteoporosis
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
- Trial name
- NCT03005678
- Testing
- Denosumab, Alendronate
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Tuen Mun Hospital
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
Low Bone Mineral Density, Postmenopausal Osteoporosis
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
The primary objective was to determine the effect of treatment with romosozumab versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low…
- Trial name
- NCT00896532
- Testing
- Alendronate, Teriparatide, Romosozumab
- Volunteers
- 419 people
- Sponsor
- Amgen
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
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
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, Chronic Kidney Disease
Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients.
- Trial name
- POSTOP (NCT01377467)
- Testing
- Denosumab (Prolia)
- Where
- Switzerland
- Volunteers
- 90 people
- Sponsor
- Rudolf Wuethrich
Bone and Joint Infection, Osteomyelitis
Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.
- Conditions
- Bone and Joint Infection, Osteomyelitis, Adverse Drug Event
- Trial name
- NCT03808285
- Testing
- mandibular osteomylitis
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Hospices Civils de Lyon
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
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
Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either…
- 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
- NCT00950911
- Testing
- amg 162
- Where
- 17 sites in Czechia, United Kingdom
- Volunteers
- 35 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate equivalent efficacy of the proposed biosimilar denosumab FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO).
- Trial name
- NCT04934072
- Testing
- FKS518, US-licensed Prolia (Amgen)
- Where
- 76 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 553 people
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
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
Denosumab Allergy, Zoledronic Acid Allergy
Denosumab vs Zoledronate After Vertebroplasty
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP).
- Trial name
- NCT05598606
- Testing
- Denosumab Injection, Zoledronate
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Shenzhen People's Hospital
Bariatric Surgery Candidate, Bone Loss
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery
Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG)…
- Trial name
- NCT04087096
- Testing
- Denosumab, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Massachusetts General Hospital
Low Bone Mass, Low Bone Mineral Density
A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
- Trial name
- NCT00887965
- Testing
- Previous denosumab
- Volunteers
- 15 people
- Sponsor
- Amgen