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| ID | Type | Description | Link |
|---|---|---|---|
| I2M-MC-GSDM | Other Identifier | Eli Lilly and Company |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blosozumab | Experimental | Weekly SC injections of blosozumab for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blosozumab | Drug | Administered subcutaneously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab | The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported. | Predose and daily up through 7 days postdose |
| 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. | Predose and daily up through 7 days postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daytona Beach | Florida | 32117 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Weekly Subcutaneous Blosozumab Injections | Blosozumab was to be administered as a subcutaneous (SC) injection (90 milligrams per milliliter (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 SC Blosozumab injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab | The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported. | Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles per milliliter | Predose and daily up through 7 days postdose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 180 mg SC Blosozumab Injection | Blosozumab was planned 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
Before Part B of the study, Eli Lilly and Company decided to stop any further dose administration; no participants entered Part B of the study. The decision was not based on safety concerns, but rather tolerability issues (injection site reactions).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000593189 | blosozumab |
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| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dallas | Texas | 75247 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles times hours per milliliter | Predose and daily up through 7 days postdose |
|
|
|
| 0 |
| 15 |
| 14 |
| 15 |
| EG001 | 90 mg SC Blosozumab Injections | Blosozumab was planned to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks. Once weekly 90 mg dose (single 1 mL injection) were administered beginning on Day 1 of Week 2. Data from all participants who received at least 1 90 mg/mL SC Blozozumab injection are included. | 0 | 15 | 15 | 15 |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site dermatitis | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site hypersensitivity | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |