A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Status: | Terminated |
---|---|
Conditions: | Osteoporosis, Osteoporosis, Postmenopausal Syndrome |
Therapuetic Areas: | Endocrinology, Rheumatology |
Healthy: | No |
Age Range: | 45 - Any |
Updated: | 1/23/2019 |
Start Date: | January 2015 |
End Date: | March 2015 |
A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
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.
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.
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
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