Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00377819 | Study of Transitioning From Alendronate to Denosumab | PHASE3 | COMPLETED | 504 | — | — | Sep 1, 2006 | Jul 1, 2008 | Jul 11, 2011 | - | — |
| NCT00293813 | A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density | PHASE2 | COMPLETED | 247 | — | — | May 1, 2006 | Aug 1, 2008 | Jul 25, 2014 | - | — |
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.
Cortical Thickness measured by XtremeCT.
| Arm | Type | Description |
|---|---|---|
| denosumab | EXPERIMENTAL | - |
| alendronate | ACTIVE_COMPARATOR | - |
| 3 | PLACEBO_COMPARATOR | Placebo for denosumab and placebo for alendronate |
| 1 | EXPERIMENTAL | denosumab and placebo for alendronate |
| 2 | ACTIVE_COMPARATOR | Placebo for denosumab and alendronate |
| Name | Type | Description |
|---|---|---|
| alendronate | DRUG | 70 mg oral QW |
| Denosumab (AMG 162) | DRUG | 60 mg SC q 6 mos |
| Denosumab | DRUG | denosumab 60 mg SC q 6 mos |
| Placebo | DRUG | Placebo for alendronate and placebo for denosumab |
Inclusion Criteria: * Postmenopausal females 55 yrs or older * Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study * Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4 Exclusion Criteria: * Vitamin D deficiency * A...