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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04779216 | Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa | PHASE3 | COMPLETED | 30 | — | — | Sep 20, 2021 | Nov 17, 2025 | Dec 16, 2025 | 1 | United States |
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
| Arm | Type | Description |
|---|---|---|
| Active Romosozumab 210mg Injection | EXPERIMENTAL | Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab. |
| Placebo | PLACEBO_COMPARATOR | Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of placebo. |
| Name | Type | Description |
|---|---|---|
| Romosozumab Prefilled Syringe | DRUG | Romosozumab 210mg Injection monthly for 12 months |
| Placebo | DRUG | Placebo Injection monthly for 12 months |
| Zoledronic acid 5 mg | DRUG | A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab or placebo |
Inclusion Criteria: * Female * Age 20-60 years, skeletally mature with closed epiphyses * Body mass index (BMI) ≥ 16.5 kg/m2 * Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria * BMD Z-score \< -1.0 * Normal serum 25-OH vitamin D (\>30 ng/mL) and calcium levels * Fo...