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The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months. |
|
| Romosozumab | Experimental | Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romosozumab | Drug | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?' | 169 days |
| Number of Participants Who Developed Antibodies to Romosozumab | All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline. | Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Concentration (Tmax) of Romosozumab | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL. | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled into 1 of 6 cohorts. In each of cohorts 1 to 4, healthy postmenopausal women were randomized in a 3:1 ratio to receive romosozumab or placebo; In each of cohorts 5 and 6, healthy men were randomized in a 3:1 ratio to receive romosozumab or placebo.
This study was conducted at 4 centers in the United States (US) from 14 November 2007 to 2 December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). |
| FG001 | Romosozumab 1 mg/kg Q2W in Women | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| FG002 | Romosozumab 2 mg/kg Q4W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| FG003 | Romosozumab 2 mg/kg Q2W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| FG004 | Romosozumab 3 mg/kg Q4W in Women | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| FG005 | Romosozumab 1 mg/kg Q2W in Men | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| FG006 | Romosozumab 3 mg/kg Q4W in Men | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). |
| BG001 | Romosozumab 1 mg/kg Q2W in Women |
| 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 Adverse Events | Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards. Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?' | All treated participants | Posted | Count of Participants | Participants | 169 days |
|
169 days
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 were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | 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 |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| 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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| Placebo | Drug | Administered by subcutaneous injection |
|
| Maximum Observed Concentration (Cmax) of Romosozumab | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
| Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts) | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
| Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169. |
| Accumulation Ratio (AR) for Romosozumab | The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose. | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
| Percent Change From Baseline in Bone Mineral Density of the Total Spine | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Bone Mineral Density at the Total Hip | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Bone Mineral Density of the Whole Body | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Baseline and days 29, 85, 127, and 169 |
| Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
| Percent Change From Baseline in Osteocalcin | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
| Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
| Percent Change From Baseline in Serum C-telopeptide (sCTX) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
| Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
| Percent Change From Baseline in Sclerostin | Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169 |
| Change From Baseline in Ionized Calcium | Baseline and day 169 (or earlier for participants who discontinued before day 169) |
| Withdrawal by Subject |
|
Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months.
| BG002 | Romosozumab 2 mg/kg Q4W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| BG003 | Romosozumab 2 mg/kg Q2W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| BG004 | Romosozumab 3 mg/kg Q4W in Women | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| BG005 | Romosozumab 1 mg/kg Q2W in Men | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| BG006 | Romosozumab 3 mg/kg Q4W in Men | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Romosozumab 1 mg/kg Q2W in Women | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| OG002 | Romosozumab 2 mg/kg Q4W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| OG003 | Romosozumab 2 mg/kg Q2W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| OG004 | Romosozumab 3 mg/kg Q4W in Women | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
| OG005 | Romosozumab 1 mg/kg Q2W in Men | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. |
| OG006 | Romosozumab 3 mg/kg Q4W in Men | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. |
|
|
| Primary | Number of Participants Who Developed Antibodies to Romosozumab | All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing. Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline. | All treated participants | Posted | Count of Participants | Participants | Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169. |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of Romosozumab | Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL. | All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated. | Posted | Median | Full Range | days | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) of Romosozumab | All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated. | Posted | Mean | Standard Deviation | μg/mL | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
|
|
|
| Secondary | Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab | Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts) | All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated. | Posted | Mean | Standard Deviation | μg*day/mL | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
|
|
|
| Secondary | Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab | All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated. | Posted | Mean | Standard Deviation | days | Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169. |
|
|
|
| Secondary | Accumulation Ratio (AR) for Romosozumab | The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose. | All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated. | Posted | Mean | Standard Deviation | ratio | Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density of the Total Spine | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density at the Total Hip | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density at the Femoral Hip | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density at the Total Wrist | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone Mineral Density of the Whole Body | Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab. | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 29, 85, 127, and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) | Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts. | Posted | Mean | Standard Error | percent change | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Osteocalcin | Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts. | Posted | Mean | Standard Error | percent change | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) | Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts. | Posted | Mean | Standard Error | percent change | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Serum C-telopeptide (sCTX) | Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts. | Posted | Mean | Standard Error | percent change | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) | Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts. | Posted | Mean | Standard Error | percent change | Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Percent Change From Baseline in Sclerostin | Treated participants with available data at baseline and each time point | Posted | Mean | Standard Error | percent change | Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169 |
|
|
|
| Secondary | Change From Baseline in Ionized Calcium | Treated participants | Posted | Mean | Standard Deviation | mg/dL | Baseline and day 169 (or earlier for participants who discontinued before day 169) |
|
|
|
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | Romosozumab 1 mg/kg Q2W in Women | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 0 | 6 | 6 | 6 |
| EG002 | Romosozumab 2 mg/kg Q4W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 0 | 6 | 6 | 6 |
| EG003 | Romosozumab 2 mg/kg Q2W in Women | Participants were randomized to receive 2 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 0 | 6 | 6 | 6 |
| EG004 | Romosozumab 3 mg/kg Q4W in Women | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 1 | 6 | 5 | 6 |
| EG005 | Romosozumab 1 mg/kg Q2W in Men | Participants were randomized to receive 1 mg/kg romosozumab by subcutaneous injection once every 2 weeks for 3 months. | 0 | 6 | 5 | 6 |
| EG006 | Romosozumab 3 mg/kg Q4W in Men | Participants were randomized to receive 3 mg/kg romosozumab by subcutaneous injection once every 4 weeks for 3 months. | 1 | 6 | 5 | 6 |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| OCULAR HYPERAEMIA | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| COLONIC POLYP | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| DIVERTICULUM INTESTINAL | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| GINGIVAL ULCERATION | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| LIP ULCERATION | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| SWOLLEN TONGUE | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| AXILLARY PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| FEELING COLD | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE BRUISING | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE DISCOMFORT | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE INDURATION | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE IRRITATION | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| SENSATION OF FOREIGN BODY | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| VENIPUNCTURE SITE SWELLING | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| INFECTED INSECT BITE | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| VULVITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| BACK INJURY | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| LIGAMENT INJURY | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| BLOOD PRESSURE INCREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| CARDIAC MURMUR | Investigations | MedDRA 17.0 | Systematic Assessment |
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| HEART RATE INCREASED | Investigations | MedDRA 17.0 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| SENSATION OF HEAVINESS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| TRIGGER FINGER | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| LETHARGY | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| DYSURIA | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| VULVOVAGINAL BURNING SENSATION | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| VULVOVAGINAL PRURITUS | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| DRY THROAT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| HAEMATOMA | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.0 | 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.
| Neutralizing antibodies |
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| Last dose |
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