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Also known as Alendronate Sodium, Fosamax®, TUMS or Viactive, Drisdol or Calciferol
Alendronate · 2 trials · 2 indications
Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
Blood samples will be collected to determine the AUC0-Last of alendronate.
Blood samples will be collected to determine the AUC0-Inf of alendronate.
Blood samples will be collected to determine the Cmax of alendronate.
Blood samples will be collected to determine the Tmax of alendronate.
Blood samples will be collected to determine the t1/2 of alendronate.
Blood samples will be collected to determine the CL/F of alendronate.
Blood samples will be collected to determine Vz/F of alendronate.
| 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). |
| Alendronate | EXPERIMENTAL | Participants receive a single oral dose of alendronate on Day 1 OR participants receive a single oral dose of alendronate on Day 15 depending on randomization. |
| Alendronate + Enlicitide Decanoate | EXPERIMENTAL | Participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization. |
| 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. |
| Enlicitide Decanoate | DRUG | Oral administration |
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...
Alendronate is used for the treatment of osteoporosis, a condition that weakens bones. It has been studied in both adults and children with osteoporosis. Alendronate is a small molecule drug developed by Merck & Company, Inc. (ticker: MRK).
Alendronate targets FDPS, which stands for farnesyl diphosphate synthase. It acts as an inhibitor of this enzyme. By inhibiting FDPS, Alendronate affects bone resorption, which is relevant to its use in osteoporosis.
Alendronate is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is a pharmaceutical company based in the United States.
Alendronate is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the studied indications. The Phase 1 trial evaluated a drug-drug interaction, while a separate Phase 2 trial studied its safety and efficacy in children with osteoporosis.
Alendronate has been studied in two completed clinical trials. NCT06772792 was a Phase 1 drug-drug interaction study in healthy adults. NCT00259857 was a Phase 2 study of safety and efficacy in children with osteoporosis. Both trials were completed and enrolled a total of 58 participants.
Yes, Alendronate is also known as Alendronate Sodium. They refer to the same active ingredient. Alendronate Sodium is the salt form commonly used in formulations.