Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT01968850
Eligibility Criteria:
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-formulated as Stribild®)
* Low (\<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations
Exclusion Criteria:
* Presence of established osteoporosis at baseline as determined by BMD measurement
* Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.)
* Inability to communicate in English
* Creatinine clearance \<35 mL/min (using Cockcroft-Gault formula)
* Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation
* Hypocalcemia
* Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
* Inability to stand or sit upright for at least 30 minutes
* Pregnancy, active plans to become pregnant, or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01968850
Study Brief:
Protocol Section:
NCT01968850