Osteoporosis, Postmenopausal
Conditions
Brief summary
The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause. This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.
Interventions
BIOLOGICALBlosozumab
Administered SC
OTHERPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Part A: Overtly healthy postmenopausal (PMP) females * Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis * Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2)
Exclusion criteria
* Have known allergies to blosozumab, its constituents, or related compounds * Have an abnormality in the 12-lead electrocardiogram (ECG) * History of breast carcinoma * Fracture of a long bone within 1 year of screening * Have used teriparatide within 3 years prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 85 | A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
Countries
United States
Participant flow
Recruitment details
This study was designed to have two parts. During Part A, one participant in each blosozumab treatment arm developed non-serious AEs, which met criteria for stopping the study. One participant was discontinued from the trial due to this AE. All other participants were discontinued due to trial termination. Part B was not conducted.
Participants by arm
| Arm | Count |
|---|---|
| Blosozumab Formulation A Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose. | 14 |
| Blosozumab Formulation B Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose. | 8 |
| Placebo Formulation A Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose. | 3 |
| Placebo Formulation B Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose. | 3 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Sponsor Decision to Terminate Study | 14 | 7 | 3 | 3 |
Baseline characteristics
| Characteristic | Total | Blosozumab Formulation A | Blosozumab Formulation B | Placebo Formulation A | Placebo Formulation B |
|---|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 5.1 | 59.3 years STANDARD_DEVIATION 4.3 | 58.1 years STANDARD_DEVIATION 5 | 56.3 years STANDARD_DEVIATION 4.6 | 56.0 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 8 Participants | 6 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 12 Participants | 7 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 28 Participants | 14 Participants | 8 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 28 Participants | 14 Participants | 8 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 14 | 5 / 8 | 2 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 14 | 0 / 8 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through Day 85
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blosozumab Formulation A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Blosozumab Formulation B | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo Formulation A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo Formulation B | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Population: All participants who received the loading dose of blosozumab and had evaluable AUC(0-tau) values.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Blosozumab Formulation A | Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B | 7880 pmol*hours per mL | Geometric Coefficient of Variation 83 |
| Blosozumab Formulation B | Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B | 6400 pmol*hours per mL | Geometric Coefficient of Variation 110 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Population: All participants who received the loading dose of blosozumab and had evaluable Cmax values.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Blosozumab Formulation A | Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B | 63.4 picomoles per milliliter (pmol/mL) | Geometric Coefficient of Variation 82 |
| Blosozumab Formulation B | Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B | 51.0 picomoles per milliliter (pmol/mL) | Geometric Coefficient of Variation 108 |
Secondary
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
Time frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Population: All participants who received the loading dose of blosozumab and had evaluable Tmax values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blosozumab Formulation A | Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B | 120 hours |
| Blosozumab Formulation B | Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B | 120 hours |