Clinical trials: Denosumab
Osteoporosis
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest…
- Trial name
- NCT01753856
- Testing
- Teriparatide, Denosumab, Demeclocycline
- Where
- 6 sites in United States, Canada
- Volunteers
- 69 people
- Sponsor
- Eli Lilly and Company
Postmenopausal Osteoporosis
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
- Trial name
- NCT04664959
- Testing
- SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab)
- Where
- 5 sites in Poland
- Volunteers
- 457 people
- Sponsor
- Samsung Bioepis Co., 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
Osteoporosis
Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one…
- Trial name
- DATA (NCT00926380)
- Testing
- denosumab, teriparatide
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Massachusetts General Hospital
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
Lung Cancer Non-small Cell Stage IV
Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung…
- Trial name
- SPLENDOUR (NCT02129699)
- Testing
- Denosumab, None, standard chemotherapy only
- Where
- 66 sites in Austria, Belgium and 9 more
- Volunteers
- 595 people
- Sponsor
- ETOP IBCSG Partners Foundation
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
Post Menopausal Osteoporosis
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
- Trial name
- NCT01732770
- Testing
- Denosumab, Zoledronic Acid
- Where
- 45 sites in United States, Australia and 5 more
- Volunteers
- 643 people
- Sponsor
- Amgen
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
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
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
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
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.
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
Osteoporosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
- Trial name
- NCT00089791
- Testing
- Denosumab
- Volunteers
- 7,808 people
- Sponsor
- Amgen