Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alendronate · 5 trials · 4 indications
A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Bone mineral density was measured using dual energy x-ray absorptiometry (DXA). Images were analyzed by a central imaging reader.
Cortical Thickness measured by XtremeCT.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence B | OTHER | When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2). |
| Treatment Sequence A | OTHER | When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2). |
| denosumab | EXPERIMENTAL | - |
| alendronate | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matching to romosozumab once a month (QM) or once every 3 months (Q3M) administered subcutaneously (SC) for up to 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| Teriparatide | ACTIVE_COMPARATOR | Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. At month 12 participants ended study participation. |
| Romosozumab 70 mg QM | EXPERIMENTAL | Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| Romosozumab 140 mg Q3M | EXPERIMENTAL | Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| Romosozumab 140 mg QM | EXPERIMENTAL | Participants received double-blind romosozumab 140 mg QM subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| Romosozumab 210 mg Q3M | EXPERIMENTAL | Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| Romosozumab 210 mg QM | EXPERIMENTAL | Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. Participants were then rerandomized to receive denosumab 60 mg or placebo to denosumab subcutaneously every 6 months from months 24 to 36. From months 36 to 48 participants received romosozumab 210 mg SC QM. At month 48 eligible participants received a single dose of open-label zoledronic acid 5 mg intravenously, or no intervention. |
| 3 | PLACEBO_COMPARATOR | Placebo for denosumab and placebo for alendronate |
| 1 | EXPERIMENTAL | denosumab and placebo for alendronate |
| 2 | ACTIVE_COMPARATOR | Placebo for denosumab and alendronate |
| Name | Type | Description |
|---|---|---|
| alendronate | DRUG | Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1. |
| denosumab | DRUG | Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1. |
| Denosumab (AMG 162) | DRUG | 60 mg SC q 6 mos |
| Placebo to Romosozumab | DRUG | Administered by subcutaneous injection QM or Q3M. |
| Teriparatide | DRUG | Teriparatide 20 μg administered by subcutaneous injection once a day |
| Romosozumab | DRUG | Administered by subcutaneous injection |
| Placebo to Denosumab | DRUG | Administered by subcutaneous injection Q6M |
| Zoledronic acid | DRUG | Zoledronic acid 5 mg administered intravenously |
| Placebo | DRUG | Placebo for alendronate and placebo for denosumab |
Inclusion Criteria: * Ambulatory postmenopausal women based on medical history * \> or = 55 years of age at the start of screening * Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular s...
| 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 low bone mineral density, osteoporosis, and postmenopausal osteoporosis. It is a small molecule being studied in postmenopausal women with these conditions. The drug is administered to female patients aged 18 years and older, depending on the specific trial.
Alendronate is being developed by Amgen Inc., which is listed on the stock exchange under the ticker AMGN. The company is conducting clinical trials to evaluate the drug's efficacy in treating bone-related conditions in postmenopausal women.
Alendronate is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in completed trials, with no active trials currently ongoing.
Alendronate has been studied in clinical trials including NCT00293813, a Phase 2 pilot study in postmenopausal women with low bone mineral density, and NCT00330460, a Phase 3 study comparing it to denosumab. These trials have been completed.
Alendronate is a small molecule that belongs to the bisphosphonate class of drugs. It works by inhibiting bone resorption, which helps to increase bone mineral density and reduce the risk of fractures in patients with osteoporosis.
No, Alendronate is not the same as Denosumab. They are different drugs that have been compared in clinical trials. Alendronate is a bisphosphonate, while Denosumab is a monoclonal antibody. Both are used to treat osteoporosis but work through different mechanisms.