A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Blosozumab

Weekly SC injections of blosozumab for 6 weeks.

Group Type EXPERIMENTAL

Blosozumab

Intervention Type DRUG

Administered subcutaneously

Interventions

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Blosozumab

Administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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LY2541546

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes