Postmenopausal Osteoporosis
Conditions
Keywords
Post Menopausal, Osteoporosis, MicroCT, Amgen, denosumab, Extreme CT, XCT, Fosamax, Alendronate
Brief summary
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
Interventions
DRUGAlendronate
Alendronate 70 mg PO QW
DRUGDenosumab
denosumab 60 mg SC q 6 mos
DRUGPlacebo
Placebo for alendronate and placebo for denosumab
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health. * Must have low bone mineral density and meet specific eligibility criteria. Key
Exclusion criteria
-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | 12 months | Cortical Thickness measured by XtremeCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | 12 months | Cortical Thickness measured by XtremeCT. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alendronate 70 mg QW Alendronate 70 mg QW | 82 |
| Denosumab 60 mg Q6M Denosumab 60 mg Q6M | 83 |
| Placebo Placebo | 82 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 | 3 |
| Overall Study | Noncompliance | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 4 | 4 |
Baseline characteristics
| Characteristic | Alendronate 70 mg QW | Denosumab 60 mg Q6M | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 60.7 Years STANDARD_DEVIATION 5.2 | 60.3 Years STANDARD_DEVIATION 5.9 | 60.8 Years STANDARD_DEVIATION 5.2 | 60.6 Years STANDARD_DEVIATION 5.4 |
| Sex: Female, Male Female | 82 Participants | 83 Participants | 82 Participants | 247 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 78 / 83 | 77 / 81 | 76 / 83 |
| serious Total, serious adverse events | 5 / 83 | 5 / 81 | 2 / 83 |
Outcome results
Primary
Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
Cortical Thickness measured by XtremeCT.
Time frame: 12 months
Population: Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Alendronate 70 mg QW | Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | 2.4 Percent Change from Baseline |
| Denosumab 60 mg Q6M | Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | 3.4 Percent Change from Baseline |
| Placebo | Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | -.8 Percent Change from Baseline |
95% CI: [2.6, 5.7]ANCOVA
95% CI: [-0.6, 2.6]ANCOVA
Secondary
Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
Cortical Thickness measured by XtremeCT.
Time frame: 12 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Alendronate 70 mg QW | Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | 4.9 Percent Change from Baseline |
| Denosumab 60 mg Q6M | Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | 5.8 Percent Change from Baseline |
| Placebo | Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | 1.4 Percent Change from Baseline |