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The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romosozumab 140 mg | Experimental | Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. |
|
| Romosozumab 210 mg | Experimental | Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine | Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab. | Baseline and day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck | Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab. | Baseline and day 85 |
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85711 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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This study was conducted at 8 centers in the United States. The first participant enrolled on 30 March 2012 and the last participant enrolled on 21 August 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Romosozumab 140 mg | Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. |
| FG001 | Romosozumab 210 mg | Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Romosozumab 140 mg | Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. |
| BG001 | Romosozumab 210 mg | Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months. |
| 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 | Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine | Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab. | All participants who received study drug and with non-missing baseline and day 85 measurements. | Posted | Mean | Standard Error | percent change | Baseline and day 85 |
|
From first dose of study drug up to day 85
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Romosozumab 140 mg | Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C557282 | romosozumab |
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Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab. |
| Baseline and day 85 |
| Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP) | Baseline and days 4, 15, 29, 43, 57, 71, and 85 |
| Percent Change From Baseline in Serum C-telopeptide (sCTX) | Baseline and days 4, 15, 29, 43, 57, 71, and 85 |
| Number of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product? A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:
| From first dose of study drug up to day 85 |
| Number of Participants Who Developed Anti-romosozumab Antibodies | Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline. | Baseline and days 29, 57, and 85 |
| Mean Serum Concentration of Romosozumab | Days 4, 15, 29, 43, 57, 71 and 85 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Research Site | Gainesville | Georgia | 30501 | United States |
| Research Site | Honolulu | Hawaii | 96813 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | West Haverstraw | New York | 10993 | United States |
| Research Site | Wyomissing | Pennsylvania | 19610 | United States |
| Research Site | Seattle | Washington | 98144 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck | Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab. | All participants who received study drug and with non-missing baseline and day 85 measurements. | Posted | Mean | Standard Error | percent change | Baseline and day 85 |
|
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip | Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab. | All participants who received study drug and with non-missing baseline and day 85 measurements. | Posted | Mean | Standard Error | percent change | Baseline and day 85 |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP) | All participants who received study drug and with available data at each time point | Posted | Mean | Standard Error | percent change | Baseline and days 4, 15, 29, 43, 57, 71, and 85 |
|
|
|
| Secondary | Percent Change From Baseline in Serum C-telopeptide (sCTX) | All participants who received study drug and with available data at each time point | Posted | Mean | Standard Error | percent change | Baseline and days 4, 15, 29, 43, 57, 71, and 85 |
|
|
|
| Secondary | Number of Participants With Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product? A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:
| All participants who received study drug | Posted | Count of Participants | Participants | From first dose of study drug up to day 85 |
|
|
|
| Secondary | Number of Participants Who Developed Anti-romosozumab Antibodies | Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline. | All participants who received study drug | Posted | Count of Participants | Participants | Baseline and days 29, 57, and 85 |
|
|
|
| Secondary | Mean Serum Concentration of Romosozumab | All participants who received study drug with available data at each time point. | Posted | Mean | Standard Deviation | ng/mL | Days 4, 15, 29, 43, 57, 71 and 85 |
|
|
|
| 0 |
| 30 |
| 11 |
| 30 |
| EG001 | Romosozumab 210 mg | Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months. | 0 | 30 | 6 | 30 |
| Injection site reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D009750 |
| Nutritional and Metabolic Diseases |
| 1.92 |
| 2-Sided |
| 90 |
| 0.95 |
| 2.89 |
| Superiority |
| Percent Change from Baseline |
| 1.40 |
| 2-Sided |
| 90 |
| 0.84 |
| 1.96 |
| Superiority |
| Day 15 |
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| Day 29 |
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| Day 43 |
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| Day 57 |
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| Day 71 |
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| Day 85 |
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| Day 15 |
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| Day 29 |
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| Day 43 |
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| Day 57 |
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| Day 71 |
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| Day 85 |
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| AE leading to discontinuation of study drug |
|
| AE leading to discontinuation from study |
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| Fatal adverse events |
|
| Treatment-related adverse events |
|
| Treatment-related serious adverse events |
|
| TRAE leading to discontinuation of study drug |
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| TRAE leading to discontinuation from study |
|
| Treatment-related fatal adverse events |
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| Day 15 |
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| Day 29 |
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| Day 43 |
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| Day 57 |
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| Day 71 |
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| Day 85 |
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