Osteoporosis, Postmenopausal
Conditions
Brief summary
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected. This study will also be looking for special markers called biomarkers that can be used to study osteoporosis and/or the effects of the study drug. There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.
Interventions
DRUGBlosozumab
Administered subcutaneously
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Show evidence of hepatitis B and/or positive hepatitis B surface antigen * Have known allergies to blosozumab, its constituents, or related compounds * Have an abnormality in the 12-lead electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab | Predose and daily up through 7 days postdose | The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported. |
| PK: Area Under the Concentration Curve of Blosozumab | Predose and daily up through 7 days postdose | The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weekly SC Blosozumab Injections Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sponsor Decision | 15 |
Baseline characteristics
| Characteristic | Weekly SC Blosozumab Injections |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
Time frame: Predose and daily up through 7 days postdose
Population: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Weekly SC Blosozumab Injections | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab | 59.8 picomoles per milliliter | Geometric Coefficient of Variation 54 |
Primary
PK: Area Under the Concentration Curve of Blosozumab
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
Time frame: Predose and daily up through 7 days postdose
Population: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Weekly SC Blosozumab Injections | PK: Area Under the Concentration Curve of Blosozumab | 7160 picomoles times hours per milliliter | Geometric Coefficient of Variation 58 |