Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criterias

Part B: PMP women who are currently taking oral bisphosphonates
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Part A: Overtly healthy PMP females
Part B: PMP women who are currently taking oral bisphosphonates
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Part A: Overtly healthy PMP females

Exclusion Criterias

Have known allergies to blosozumab, its constituents, or related compounds
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have an abnormality in the 12-lead electrocardiogram (ECG)
...
Have known allergies to blosozumab, its constituents, or related compounds
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have an abnormality in the 12-lead electrocardiogram (ECG)
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody

Summary

Conditions
Osteoporosis, Postmenopausal
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 60 years and 125 years
Gender
Only females

Inclusion Criterias

Part B: PMP women who are currently taking oral bisphosphonates
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Part A: Overtly healthy PMP females
Part B: PMP women who are currently taking oral bisphosphonates
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Part A: Overtly healthy PMP females

Exclusion Criterias

Have known allergies to blosozumab, its constituents, or related compounds
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have an abnormality in the 12-lead electrocardiogram (ECG)
...
Have known allergies to blosozumab, its constituents, or related compounds
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have an abnormality in the 12-lead electrocardiogram (ECG)
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody

Locations

Dallas, Texas, 75247
Daytona Beach, Florida, 32117
Dallas, Texas, 75247
Daytona Beach, Florida, 32117

Tracking Information

NCT #
NCT02109042
Collaborators
Not Provided
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company