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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00259857 | Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis | PHASE2 | COMPLETED | 22 | — | — | Oct 1, 2003 | Aug 1, 2009 | Jan 19, 2011 | 1 | United States |
Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
| Arm | Type | Description |
|---|---|---|
| 1 Alendronate, Calcium, Vitamin D | EXPERIMENTAL | Crossover study. Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements. Year-2, they will crossover to the second arm of the study. Those who took study medication and supplements in year-1, will take placebo and supplements in the year-2, and those 10 participants who took placebo and supplements in the year-1, will take study medications and supplements in the year-2. |
| 2 Placebo, Calcium and Vitamin D | PLACEBO_COMPARATOR | Year-1, 10 participants will take Alendronate (study medication)and calcium and vitamin D supplement). Another 10 participants will take placebo, calcium and vitamin D. In year-2 they will crossover. Those who took alendronate in the first year, will take Placebo, calcium and vitamin D for 12 months and those who took Placebo in the first year, will take Alendronate, calcium and vitamin D in the second year (12 months). |
| Name | Type | Description |
|---|---|---|
| Alendronate | DRUG | Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. |
Eligibility Criteria: * 5-15 yrs of age * Weighing 20 kg and more * History of multiple fractures * Tanner stage II or less * Osteoporosis by DXA. Inclusion Criteria: * Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | NA | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | — | Undisclosed |