Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| 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 is used for osteoporosis and is being studied in healthy adults. It is a small molecule developed by Merck & Company, Inc. (MRK). In clinical trials, it has been evaluated in children with osteoporosis and in healthy adult participants for drug-drug interaction studies.
Alendronate is developed by Merck & Company, Inc., which trades under the ticker MRK. The company has conducted clinical trials evaluating the drug in osteoporosis and healthy populations.
Alendronate is in Phase 1 clinical development. It has completed trials, including a Phase 2 study in children with osteoporosis and a Phase 1 study in healthy adults. It remains investigational and is not approved for the studied indications.
Alendronate has been studied in two completed trials: NCT00259857, a Phase 2 safety and efficacy study in children with osteoporosis, and NCT06772792, a Phase 1 drug-drug interaction study with enlicitide decanoate in healthy adults. Both trials were conducted in the United States.
Yes, Alendronate is the same as Fosamax. The clinical trial NCT00259857 is titled 'Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis,' confirming that Fosamax is an alternative name for Alendronate.