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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01406548 | Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density | PHASE2 | COMPLETED | 44 | — | — | Jul 1, 2011 | Oct 1, 2013 | Sep 15, 2022 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| BPS804 dosing frequency 1 | EXPERIMENTAL | Subjects dosed 20mg/Kg BPS804 monthly |
| placebo dosing frequency 1 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly |
| BPS804 dosing frequency 2 | EXPERIMENTAL | Subjects dosed with 20mg/Kg BPS804 quarterly |
| placebo dosing frequency 2 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months |
| BPS804 dosing frequency 3 | EXPERIMENTAL | Subjects dosed with 20mg/Kg BPS804 weekly |
| Placebo dosing frequency 3 | PLACEBO_COMPARATOR | Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly |
| Name | Type | Description |
|---|---|---|
| BPS804 20mg/Kg | DRUG | - |
| Placebo to 20mg/Kg BPS804 | DRUG | - |
Inclusion Criteria: * Postmenopausal women (natural or surgically induced menopause) * Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive * Body mass index (BMI) must be within the range of 18 to 35kg...