Trial Outcomes & Findings for A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis (NCT NCT02791516)
NCT ID: NCT02791516
Last Updated: 2019-10-07
Results Overview
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Baseline and month 6
Results posted on
2019-10-07
Participant Flow
This study was conducted at 10 centers in South Korea. Participants were enrolled from 16 January 2017 to 17 August 2017.
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.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
Completed 6-month Treatment Period
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=34 Participants
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Age, Customized
< 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Lumbar Spine Bone Mineral Density (BMD) T-score
|
-2.6483 T-score
STANDARD_DEVIATION 0.6450 • n=5 Participants
|
-2.6622 T-score
STANDARD_DEVIATION 0.8155 • n=7 Participants
|
-2.6554 T-score
STANDARD_DEVIATION 0.7310 • n=5 Participants
|
|
Total Hip BMD T-score
|
-2.1797 T-score
STANDARD_DEVIATION 0.6243 • n=5 Participants
|
-2.1515 T-score
STANDARD_DEVIATION 0.7114 • n=7 Participants
|
-2.1654 T-score
STANDARD_DEVIATION 0.6650 • n=5 Participants
|
|
Femoral Neck BMD T-score
|
-2.5309 T-score
STANDARD_DEVIATION 0.5395 • n=5 Participants
|
-2.4494 T-score
STANDARD_DEVIATION 0.6069 • n=7 Participants
|
-2.4896 T-score
STANDARD_DEVIATION 0.5718 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and month 6Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement 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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=33 Participants
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
|
-0.1 percent change
Standard Error 0.8
|
9.5 percent change
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement 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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=33 Participants
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
|
0.3 percent change
Standard Error 0.4
|
2.9 percent change
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and month 6Population: Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement 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.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=33 Participants
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
|
0.8 percent change
Standard Error 0.7
|
3.0 percent change
Standard Error 0.6
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Romosozumab 210 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=34 participants at risk
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Infections and infestations
Pulmonary tuberculosis
|
3.0%
1/33 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/34 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
3.0%
1/33 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/34 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
3.0%
1/33 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/34 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
Participants received placebo subcutaneous injection once a month for 6 months.
|
Romosozumab 210 mg
n=34 participants at risk
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
1/34 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
2/33 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
1/34 • 9 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER