Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
alendronate cholecalciferol · 2 trials · 1 indication
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 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Alendronate cholecalciferol is used for osteoporosis. It is a small molecule being developed by Organon & Co. (OGN) and is currently in Phase 1 clinical development. The drug combines alendronate with vitamin D3 and is being studied in postmenopausal osteoporotic women and healthy volunteers.
Alendronate cholecalciferol targets bone metabolism through its alendronate component, a bisphosphonate that inhibits bone resorption, combined with cholecalciferol (vitamin D3) to support calcium absorption. The drug is being studied for its effect on fractional calcium absorption in postmenopausal osteoporotic women.
Alendronate cholecalciferol is developed by Organon & Co., a pharmaceutical company traded under the ticker OGN. The drug is currently in Phase 1 clinical development for osteoporosis.
Alendronate cholecalciferol is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, with a total enrollment of 300 participants.
Alendronate cholecalciferol has two completed Phase 1 trials: NCT00641771, a 4-week study assessing the effect of alendronate and vitamin D3 once weekly on fractional calcium absorption in postmenopausal osteoporotic women (enrollment 56), and NCT00806416, a bioequivalence study of 70 mg alendronate alone versus in combination with 2800 IU vitamin D (enrollment 244).
Alendronate cholecalciferol is a combination of alendronate and cholecalciferol (vitamin D3). It is being studied as a once-weekly formulation for osteoporosis. The drug is distinct from alendronate alone, as it includes vitamin D3 to enhance calcium absorption.