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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000434-35 | EudraCT Number |
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The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:
After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.
For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Romosozumab 90 mg/mL | Experimental | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. |
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| Placebo 90 mg/mL | Experimental | Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. |
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| Romosozumab 70 mg/mL | Experimental | Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. |
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| Placebo 70 mg/mL | Placebo Comparator | Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab 90 mg/mL | Drug | Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Hip BMD | Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score. | Baseline and month 6 |
| Percent Change From Baseline in Femoral Neck BMD |
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Inclusion Criteria:
Postmenopausal women with osteoporosis at high risk for fracture defined as
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gainesville | Georgia | 30501 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Eligible participants were randomized in a 22:5:22:5 ratio to receive
For efficacy analyses the 2 placebo groups were combined, for safety analyses the data were reported separately.
This study was conducted at 11 centers: 7 in Poland, 2 in the Czech Republic, and 2 in the United States. The first participant enrolled on 03 December 2013 and the last participant enrolled on 07 March 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months. |
| FG001 | Romosozumab 70 mg/mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo 90 mg/mL | Drug | Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS. |
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| Romosozumab 70 mg/mL | Drug | Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS. |
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| Placebo 70 mg/mL | Drug | Placebo administered as 3 SC injections with the 1.0 mL glass PFS. |
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Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score. |
| Baseline and month 6 |
| Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) | Baseline, month 1, month 3, and month 6 |
| Percent Change From Baseline in Serum C-Telopeptide (CTX) | Baseline, month 1, month 3, and month 6 |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| Research Site | Brno | 602 00 | Czechia |
| Research Site | Klatovy | 339 01 | Czechia |
| Research Site | Uherské Hradiště | 686 01 | Czechia |
| Research Site | Gdynia | 81-384 | Poland |
| Research Site | Gliwice | 44-100 | Poland |
| Research Site | Katowice | 40-040 | Poland |
| Research Site | Krakow | 31-501 | Poland |
| Research Site | Åšwidnik | 21-040 | Poland |
| Research Site | Warsaw | 01-192 | Poland |
| Research Site | Wroclaw | 50-088 | Poland |
Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.
| FG002 | Romosozumab 90 mg/mL | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months. |
| Received Study Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants (full analysis set)
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months. |
| BG001 | Romosozumab 70 mg/mL | Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months. |
| BG002 | Romosozumab 90 mg/mL | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| Ethnicity (NIH/OMB) | 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 the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman. | Mean | Standard Deviation | T-score |
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| Total Hip BMD T-score | Mean | Standard Deviation | T-score |
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| Femoral Neck BMD T-score | Mean | Standard Deviation | T-score |
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| Serum Procollagen Type 1 N-telopeptide (P1NP) | Participants with available data | Median | Inter-Quartile Range | μg/L |
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| Serum Type 1 Collagen C-telopeptide (CTX) | Participants with available data | Median | Inter-Quartile Range | ng/L |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | All randomized participants who had a baseline and a month 6 lumbar spine DXA BMD measurement | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline in Total Hip BMD | Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score. | All randomized participants who had a baseline and month 6 hip DXA BMD measurement. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline in Femoral Neck BMD | Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score. | All randomized participants who had a baseline and month 6 femoral neck DXA BMD measurement. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline and month 6 |
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| Secondary | Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) | All randomized participants who had a baseline and at least one postbaseline measurement for P1NP, and with available data at each time point. | Posted | Median | Inter-Quartile Range | percent change | Baseline, month 1, month 3, and month 6 |
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| Secondary | Percent Change From Baseline in Serum C-Telopeptide (CTX) | All randomized participants who had a baseline and at least one postbaseline measurement for CTX and with available data at each time point. | Posted | Median | Inter-Quartile Range | percent change | Baseline, month 1, month 3, and month 6 |
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Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall).
One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events.
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 70 mg | Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months. | 4 | 26 | 9 | 26 | ||
| EG001 | Placebo 90 mg/mL | Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. | 2 | 26 | 5 | 26 | ||
| EG002 | Romosozumab 70 mg/mL | Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months. | 7 | 119 | 24 | 119 | ||
| EG003 | Romosozumab 90 mg/mL | Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months. | 3 | 123 | 38 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Appendicitis noninfective | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Mesenteric artery embolism | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Appendicitis perforated | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Spinal deformity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Vertebral lesion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Medullary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Retrograde amnesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Umbilical hernia repair | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
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| Arterial rupture | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | 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 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557282 | romosozumab |
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