Clinical trials: Denosumab, completed
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
Osteonecrosis Due to Drugs, Jaw
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction
The aim of this trial is to evaluate high-dose antiresorptive drug holiday related to tooth extraction with primary mucosal closure (surgical extraction) including how a drug holiday affects the health related quality of life.
- Trial name
- DrugHoliday (NCT04540601)
- Testing
- Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)
- Where
- 2 sites in Denmark
- Volunteers
- 30 people
- Sponsor
- University of Copenhagen
Postmenopausal Osteoporosis
Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass
The primary aim of the study is the comparative effect of zolendronic acid versus denosumab on serum sclerostin levels in postmenopausal women with low bone mass.
- Trial name
- DenoZol (NCT01572545)
- Testing
- Denosumab, Zoledronic acid
- Where
- 3 sites in Greece
- Volunteers
- 91 people
- Sponsor
- Aristotle University Of Thessaloniki
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
Breast Cancer
Presurgical Trial of Denosumab in Breast Cancer
The purpose of this study is to determine whether one dose of denosumab can lead to changes in the tumor, which may decrease the ability of tumor to spread.
- Trial name
- NCT02900469
- Testing
- denosumab, Surgery
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- NYU Langone Health