Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss (NCT02322099) | Clinical Trial Compass
TerminatedPhase 4
Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss
Stopped: Due to the COVID-19 pandemic the study was terminated prematurely
Ireland53 participantsStarted 2016-05
Plain-language summary
Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy. Bisphosphonates, such as alendronate, decrease bone turnover and can limit loss of bone mineral density.
This study aims to determine if a short course of treatment with the oral bisphosphonate alendronate can limit loss of bone mineral density associated with initiation of ART in HIV-1 infected, antiretroviral naive, adult subjects.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* male\>30 years old or female\>35 years old
* HIV-1 antibody positive
* antiretroviral therapy naïve
* be presumed to have achieved peak bone mass
* be eligible for initiation of antiretroviral therapy in the opinion of the investigator
* be able to provide written, informed consent
Exclusion Criteria:
* subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes
* history of osteoporosis
* history of fragility fracture or previous femoral fracture
* chronic renal failure
* hypocalcemia or hypercalcemia at screening
* history of Paget's disease or known primary hyperparathyroidism
* previous treatment with or allergy (including hypersensitivity) to bisphosphonates
* recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other abnormality of the oesophagus
* current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations)
* current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs
* recent dental work (within the past 3 months) or poor oral hygiene (as judged in the opinion of the investigator)
* recent (within the past three months) significant steroid exposure
* for female subjects: pregnancy at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
* where in the investigator's opinion, there is a necessity to…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.