Osteoporosis
Conditions
Keywords
RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
Brief summary
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.
Interventions
DRUG100 mg AMG 162
100 mg AMG 162 (denosumab) SC every 6 months
DRUG60 mg AMG 162
60 mg AMG 162 (denosumab) SC every 6 months
DRUG14 mg AMG 162
14 mg AMG 162 (denosumab) SC every 6 months
DRUGPlacebo
Placebo SC every 6 months
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
- Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip.
Exclusion criteria
- Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | 12 months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Denosumab 14 mg Q6M | 53 |
| Denosumab 60 mg Q6M | 54 |
| Denosumab 100 mg Q6M | 50 |
| Placebo | 55 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 2 | 2 |
| Overall Study | Ineligibility determined | 1 | 1 | 1 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 8 | 1 |
Baseline characteristics
| Characteristic | Denosumab 14 mg Q6M | Denosumab 60 mg Q6M | Denosumab 100 mg Q6M | Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 65.9 Years STANDARD_DEVIATION 7.1 | 65.1 Years STANDARD_DEVIATION 6.3 | 64.6 Years STANDARD_DEVIATION 7.1 | 64.6 Years STANDARD_DEVIATION 7 | 65.1 Years STANDARD_DEVIATION 6.8 |
| Sex: Female, Male Female | 53 Participants | 54 Participants | 50 Participants | 55 Participants | 212 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 49 / 54 | 50 / 53 | 47 / 54 | 48 / 51 |
| serious Total, serious adverse events | 4 / 54 | 6 / 53 | 4 / 54 | 2 / 51 |
Outcome results
Primary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 12 months
Population: All subjects who received \>= 1 dose of investigational product and have a baseline and \>= 1 post baseline measurement at the lumbar spine.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | .46 Percent Change from Baseline |
| Denosumab 14 mg Q6M | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | 5.71 Percent Change from Baseline |
| Denosumab 60 mg Q6M | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | 6.73 Percent Change from Baseline |
| Denosumab 100 mg Q6M | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | 7.45 Percent Change from Baseline |
p-value: <0.000195% CI: [5.76, 8.24]t-test, 2 sided
p-value: <0.000195% CI: [4.1, 6.4]t-test, 2 sided
p-value: <0.000195% CI: [5.06, 7.49]t-test, 2 sided