Approval Probability
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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...
Alendronate cholecalciferol is a small molecule combination therapy being developed by Organon & Co. (ticker: OGN) for osteoporosis. It pairs alendronate, a bisphosphonate, with cholecalciferol, a form of vitamin D3. The combination is intended to support bone health in patients with osteoporosis.
Alendronate cholecalciferol targets farnesyl diphosphate synthase (FDPS). Alendronate acts as an inhibitor of FDPS, an enzyme in the mevalonate pathway, which affects osteoclast function and bone resorption. Cholecalciferol is a vitamin D3 form that supports calcium absorption and bone mineralization.
Alendronate cholecalciferol is being developed by Organon & Co., which trades under the ticker OGN. Organon is the company responsible for the development of this combination product.
Alendronate cholecalciferol is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes completed trials evaluating bioequivalence and effects on calcium absorption.
Alendronate cholecalciferol has been studied in two completed Phase 1 trials: NCT00806416, a bioequivalence study of 70 mg alendronate with 2800 IU vitamin D in 244 participants, and NCT00641771, a 4-week study of alendronate and vitamin D3 on fractional calcium absorption in 56 postmenopausal osteoporotic women.