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Also known as alendronate
Comparator: alendronate · 3 trials · 3 indications
Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. 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 on Days 1 and 2.
The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
| Arm | Type | Description |
|---|---|---|
| Alendronate 70 mg | EXPERIMENTAL | Alendronate sodium, 70 mg, orally once weekly for up to 24 months |
| Risendronate 35 mg | ACTIVE_COMPARATOR | Risendronate, 35 mg, orally once weekly for up to 24 months |
| Sequence 1- alendronate+vitamin D combination then alendronate | EXPERIMENTAL | Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 2 alendronate then alendronate+vitamin D combination | EXPERIMENTAL | Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 3 alendronate+vitamin D combination then vitamin D | EXPERIMENTAL | Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 4- vitamin D then alendronate+vitamin D combination | EXPERIMENTAL | Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Name | Type | Description |
|---|---|---|
| Alendronate | DRUG | Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
| Risedronate 35 mg | DRUG | Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
| Elemental Calcium | DIETARY_SUPPLEMENT | Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose. |
| Vitamin D | DIETARY_SUPPLEMENT | Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose. |
| Risendronate placebo | DRUG | Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
| Alendronate placebo | DRUG | Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose. |
| alendronate sodium+vitamin D combination | DRUG | A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. |
| Comparator: alendronate | DRUG | A single dose tablet of 70mg alendronate in one treatment period of each sequence. |
| Comparator: Vitamin D | DIETARY_SUPPLEMENT | Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence. |
Inclusion Criteria: * Women with postmenopausal osteoporosis Exclusion Criteria: * Bilateral hip replacements * Esophageal abnormalities * Metabolic bone disease (example - Vitamin D deficiency) * Medications that would affect the breakdown or build-up of bone turnover
Alendronate is used for osteoporosis, postmenopausal osteoporosis, and Paget's disease of bone. It is a small molecule being developed by Organon & Co. (NYSE: OGN) for these endocrine conditions. The drug is currently in Phase 3 clinical development for these indications.
Alendronate is a bisphosphonate that works by inhibiting bone resorption. It binds to hydroxyapatite in bone and is taken up by osteoclasts, leading to osteoclast apoptosis and reduced bone turnover. This mechanism helps increase bone mineral density and reduce fracture risk in osteoporosis and Paget's disease.
Alendronate is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for osteoporosis and Paget's disease of bone.
Alendronate is in Phase 3 clinical development for osteoporosis, postmenopausal osteoporosis, and Paget's disease of bone. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its effectiveness and safety in these patient populations.
Alendronate has been studied in several clinical trials. NCT00092014 is a Phase 3 study comparing alendronate and risedronate on bone mineral density in women with postmenopausal osteoporosis, with 1053 participants. NCT00480662 is a Phase 3 trial in patients with Paget's disease of bone, enrolling 60 participants. NCT00803790 is a Phase 1 bioequivalence study in osteoporosis.
Alendronate is the generic name for the drug also known as Fosamax. The trials listed use the brand name MK-0217, which is another identifier for alendronate. This medication is being studied for osteoporosis and Paget's disease, and it is important to recognize these alternative names when searching for clinical information.