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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00641771 | 4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230) | PHASE1 | COMPLETED | 56 | — | — | May 1, 2004 | Aug 1, 2005 | Feb 2, 2022 | - | — |
| NCT00806416 | A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D | PHASE1 | COMPLETED | 244 | — | — | May 1, 2003 | Jan 1, 2004 | Feb 8, 2022 | - | — |
Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.
Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MK0217A |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Sequence 1 | EXPERIMENTAL | alendronate/vitamin D combination then alendronate |
| Sequence 2 | EXPERIMENTAL | alendronate then alendronate/vitamin D combination |
| Sequence 3 | EXPERIMENTAL | alendronate/vitamin D combination then vitamin D |
| Sequence 4 | EXPERIMENTAL | vitamin D then alendronate/vitamin D combination |
| Name | Type | Description |
|---|---|---|
| alendronate sodium (+) cholecalciferol | DRUG | MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down. |
| Comparator: Placebo (unspecified) | DRUG | MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down. |
| Comparator: alendronate | DRUG | A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period. |
| Comparator: cholecalciferol (Vitamin D) | DIETARY_SUPPLEMENT | A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. |
Inclusion Criteria: * The patient is a postmenopausal osteoporotic female * The patient is willing to limit direct sunlight exposure during the course of the study * The patient must be ambulatory * The patient has serum 25-hydroxyvitamin D =25 ng/mL Exclusion Criteria: * The patient is contraind...
| 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 |