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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04403698 | The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover | PHASE2 | COMPLETED | 30 | — | — | Nov 13, 2019 | Mar 9, 2022 | Dec 13, 2024 | 1 | Belgium |
Difference in bone turnover marker C-terminal telopeptide of type I collagen (CTX-I) after 48 weeks. Comparisons made within and between both treatment arms
Difference in Bone Turnover Marker N-terminal propeptide of type I procollagen (PINP) After 48 Weeks. Comparisons are made both within and between both treatment arms.
| Arm | Type | Description |
|---|---|---|
| 24 weeks | EXPERIMENTAL | Subject receiving alendronate treatment for 24 weeks (n = 20) |
| 48 weeks | EXPERIMENTAL | Subject receiving alendronate treatment for 48 weeks (n = 20) |
| Name | Type | Description |
|---|---|---|
| Alendronate Effervescent Oral Tablet | DRUG | At the earliest three months but no later than four months after the last denosumab injection, subjects will be randomized to effervescent alendronate administered for either 24 or 48 weeks |
Inclusion Criteria: * Subjects must have completed the 48 weeks of the randomised placebo-controlled study phase followed by the 96 weeks open label denosumab 60 mg SC every 3 months phase. (EudraCT number: 2015-003223-53) * Last denosumab injection minimal 3 months or maximum 4 months before basel...