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alendronate/vitamin D · 1 trial · 1 indication
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
| Arm | Type | Description |
|---|---|---|
| no bone anti-resorptive therapy | NO_INTERVENTION | (standard of care) |
| 24-week tx of alendronate/vitamin D | EXPERIMENTAL | Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D |
| Delayed 24-week tx of alendronate/vitamin D | EXPERIMENTAL | a 24 week delay in initiation of a 24 week course of alendronate/vitamin D |
| Name | Type | Description |
|---|---|---|
| alendronate/vitamin D | DRUG | once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks. |
Inclusion Criteria: * Documented HIV-1 infection * Adult (aged \>18 years or as per local guidelines) * Premenopausal, if female * Antiretroviral-naïve * Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formu...
Alendronate/vitamin D is a small molecule being studied for use in HIV. It is being investigated as a bone antiresorptive therapy to be given alongside antiretroviral initiation in HIV patients. The drug is currently in Phase 2 clinical development by Unity Biotechnology, Inc. for this infectious disease indication.
Alendronate/vitamin D is a bisphosphonate and vitamin D combination. Alendronate works by inhibiting bone resorption, while vitamin D aids in calcium absorption and bone mineralization. In the context of HIV, it is being studied to address bone loss that can occur with antiretroviral therapy.
Alendronate/vitamin D is being developed by Unity Biotechnology, Inc., a company traded on the stock exchange under the ticker UBX. The company is conducting clinical research on this drug for the treatment of HIV-related bone conditions.
Alendronate/vitamin D is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial for this drug has been completed, with results expected to inform further development decisions.
Alendronate/vitamin D has one completed Phase 2 clinical trial, identified as NCT01968850, titled "Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial." This study enrolled 30 participants with HIV in Canada and was a randomized, no-treatment controlled trial.
Alendronate/vitamin D is a combination product that includes both alendronate and vitamin D. It is distinct from alendronate alone, as the addition of vitamin D is intended to support bone health. This combination is being studied specifically in the context of HIV treatment.