Clinical trials: Denosumab
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
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Postmenopausal Osteoporosis
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.
- Trial name
- NCT04026256
- Testing
- Teriparatide, Denosumab
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Postmenopausal Osteoporosis
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide.
- Trial name
- DATA-HD (NCT02176382)
- Testing
- denosumab, teriparatide, Zoledronic acid
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
- Trial name
- NCT01750086
- Testing
- Teriparatide 40-mcg subcutaneous injection, Denosumab Injection, Alendronate Oral Tablet
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Healthy Volunteer
Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12 healthy male subjects will receive a subcutaneous injection of denosumab on Day 1.
- Trial name
- NCT01869686
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amgen