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The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injection once a month for 6 months. |
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| Romosozumab | Experimental | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | Administered by subcutaneous injection once a month (QM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine | Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 |
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | 602-739 | South Korea | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33677928 | Derived | Baek KH, Chung YS, Koh JM, Kim IJ, Kim KM, Min YK, Park KD, Dinavahi R, Maddox J, Yang W, Kim S, Lee SJ, Cho H, Lim SK. Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were randomized in a 1:1 ratio to receive either romosozumab 210 mg subcutaneously (SC) QM or matched placebo SC QM. Upon completion of the 6-month treatment period, participants were followed for an additional 3 months.
This study was conducted at 10 centers in South Korea. Participants were enrolled from 16 January 2017 to 17 August 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneous injection once a month for 6 months. |
| FG001 | Romosozumab 210 mg | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2017 | Apr 10, 2019 |
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| Placebo | Drug | Administered by subcutaneous injections once a month |
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Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. |
| Baseline and month 6 |
| Gwangju |
| 501-757 |
| South Korea |
| Research Site | Namdong-gu, Incheon | 21565 | South Korea |
| Research Site | Seongnam Si Gyeonggi Do | 463-707 | South Korea |
| Research Site | Seoul | 120-752 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 136-705 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
| Research Site | Seoul | 150-713 | South Korea |
| Research Site | Suwon-si, Gyeonggi-do | 443-380 | South Korea |
| Completed 6-month Treatment Period |
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| COMPLETED | Completed 9-month study period |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneous injection once a month for 6 months. |
| BG001 | Romosozumab 210 mg | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Lumbar Spine Bone Mineral Density (BMD) T-score | The T-score is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex. Lower scores (more negative) mean lower bone density: A T-score of -2.5 or lower qualifies as osteoporosis and a T-score of -1.0 to - 2.5 signifies osteopenia, meaning below-normal bone density without full osteoporosis. | Mean | Standard Deviation | T-score |
| ||||||||||||||
| Total Hip BMD T-score | The T-score is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex. Lower scores (more negative) mean lower bone density: A T-score of -2.5 or lower qualifies as osteoporosis and a T-score of -1.0 to - 2.5 signifies osteopenia, meaning below-normal bone density without full osteoporosis. | Mean | Standard Deviation | T-score |
| ||||||||||||||
| Femoral Neck BMD T-score | The T-score is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex. Lower scores (more negative) mean lower bone density: A T-score of -2.5 or lower qualifies as osteoporosis and a T-score of -1.0 to - 2.5 signifies osteopenia, meaning below-normal bone density without full osteoporosis | Mean | Standard Deviation | T-score |
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| 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 to Month 6 in Bone Mineral Density at the Lumbar Spine | Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the lumbar spine. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the total hip. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the femoral neck. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and month 6 |
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9 months
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 | Placebo | Participants received placebo subcutaneous injection once a month for 6 months. | 0 | 33 | 2 | 33 | 4 | 33 |
| EG001 | Romosozumab 210 mg | Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. | 0 | 34 | 0 | 34 | 2 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2018 | Apr 10, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557282 | romosozumab |
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| ≥ 65 to < 75 years |
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| ≥ 75 years |
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| Male |
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