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| ID | Type | Description | Link |
|---|---|---|---|
| I2M-MC-GSDT | Other Identifier | Eli Lilly and Company |
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Protocol stopping criteria (safety) were met.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blosozumab Formulation A | Experimental | Part A. Blosozumab administered as 2 subcutaneous (SC) injections in week 1 followed by once weekly (QW) injections SC in weeks 2 to 6, followed by six week follow-up period. |
|
| Blosozumab Formulation B | Experimental | Part A. Blosozumab administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period. |
|
| Placebo | Placebo Comparator | Part A. Placebo administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period. |
|
| Blosozumab (Part B) | Experimental | Part B. Blosozumab formulation determined by Part A administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blosozumab | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Day 85 |
| Measure | Description | 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 |
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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 |
|---|---|---|---|---|---|---|
| Covance | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Inc |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blosozumab Formulation A | Part A - Blosozumab Formulation A administered as a 180 milligram (mg) loading dose subcutaneously (SC) in Week 1 followed by 90 mg SC once weekly (QW) for 5 weeks. Participants were followed for 7 weeks after the last dose. |
| FG001 | Blosozumab Formulation B | Part A - 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. |
| FG002 | Placebo Formulation A | Part 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. |
| FG003 | Placebo Formulation B | Part A - 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Blosozumab Formulation B |
| 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 | 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. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 85 |
|
Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
Protocol stopping criteria (safety) were met. Non-serious AEs met criteria for stopping the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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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| Placebo | Other | Administered SC |
|
| 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 |
| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance | Dallas | Texas | 75247-4989 | United States |
| Sponsor Decision to Terminate Study |
|
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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
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.
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B | All participants who received the loading dose of blosozumab and had evaluable Cmax values. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles per milliliter (pmol/mL) | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
|
|
|
| Secondary | Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B | All participants who received the loading dose of blosozumab and had evaluable Tmax values. | Posted | Median | Full Range | hours | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B | All participants who received the loading dose of blosozumab and had evaluable AUC(0-tau) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*hours per mL | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |
|
|
|
| 0 |
| 14 |
| 11 |
| 14 |
| EG001 | 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. | 0 | 8 | 5 | 8 |
| EG002 | 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. | 0 | 3 | 2 | 3 |
| EG003 | 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. | 0 | 3 | 0 | 3 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |