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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00103740 | Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period | PHASE3 | COMPLETED | 185 | — | — | Apr 1, 2002 | Apr 1, 2011 | Jun 4, 2012 | 41 | United States, Australia +8 |
| NCT00051636 | Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period | PHASE3 | COMPLETED | 172 | — | — | Jan 1, 2001 | Apr 1, 2011 | May 15, 2012 | 34 | United States, Australia +4 |
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
| Arm | Type | Description |
|---|---|---|
| Zoledronic acid and placebo to risedronate | EXPERIMENTAL | Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. |
| Risedronate and placebo to zoledronic acid | ACTIVE_COMPARATOR | Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. |
| Name | Type | Description |
|---|---|---|
| zoledronic acid | DRUG | 5 mg zoledronic acid in 5 mL of sterile water for infusion |
| placebo to zoledronic acid | DRUG | 5 mL of sterile water for infusion |
| Risedronate | DRUG | 30mg oral tablets overencapsulated to match the placebo capsules |
| Placebo to risedronate | DRUG | oral capsules |
| Calcium and vitamin D supplements | DRUG | Calcium and vitamin D supplements were supplied |
| Calcium and Vitamin D | DIETARY_SUPPLEMENT | Calcium and vitamin D supplements were supplied. |
Inclusion Criteria: * 30 years or older * SAP 2 times ULN * Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.). * 90 days washout calcitonin * 180 day washout bisphosphonate Exclusion Criteria: * Allergic ...