Postmenopausal Osteoporosis
Conditions
Keywords
Osteoporosis, Postmenopausal
Brief summary
This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.
Interventions
DRUGAMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
DRUGPlacebo
Placebo given at day 1, month 6, month 12 and month 18
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria \- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | 24 Months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | 24 Months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
| Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
| Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | 24 Months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
| Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). |
| Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). |
| Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). |
| Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 | 24 months | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Denosumab 60 mg Q6M | 166 |
| Placebo | 166 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Ineligibility determined | 2 | 0 |
| Overall Study | Lost to Follow-up | 7 | 5 |
| Overall Study | Noncompliance | 2 | 0 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 15 |
Baseline characteristics
| Characteristic | Denosumab 60 mg Q6M | Placebo | Total |
|---|---|---|---|
| Age Continuous | 59.8 Years STANDARD_DEVIATION 7.4 | 58.9 Years STANDARD_DEVIATION 7.5 | 59.4 Years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 166 Participants | 166 Participants | 332 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 157 / 165 | 156 / 164 |
| serious Total, serious adverse events | 9 / 165 | 18 / 164 |
Outcome results
Primary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 Months
Population: Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | 6.5 Percent Change from Baseline |
| Placebo | Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | -.6 Percent Change from Baseline |
p-value: <0.000195% CI: [6.2, 7.8]ANCOVA
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 | 1.4 Percent Change from Baseline |
| Placebo | Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 | -2.1 Percent Change from Baseline |
Secondary
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | .3 Percent Change from Baseline |
| Placebo | Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | -1.4 Percent Change from Baseline |
Secondary
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | .8 Percent Change from Baseline |
| Placebo | Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | -1.9 Percent Change from Baseline |
Secondary
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | 8.7 Percent Change from Baseline |
| Placebo | Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | -.7 Percent Change from Baseline |
Secondary
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 Months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | 2.8 Percent Change from Baseline |
| Placebo | Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | -.9 Percent Change from Baseline |
Secondary
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 | 2.4 Percent Change from Baseline |
| Placebo | Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 | -1.4 Percent Change from Baseline |
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 Months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | 3.4 Percent Change from Baseline |
| Placebo | Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | -1.1 Percent Change from Baseline |
Secondary
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Denosumab 60 mg Q6M | Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 | 5.2 Percent Change from Baseline |
| Placebo | Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 | -.8 Percent Change from Baseline |