CTNPT 021: The (BATARI) Pilot Trial

Study Approach

This study involves either taking a bone-building medication (called alendronate with vitamin D, or Fosavance) once a week for 6 months starting immediately, or starting six months into the study, or taking no bone-building medication. The purpose of the study is to collect information about the health effects, acceptability and feasibility of this strategy in people starting HIV treatment. The drug and dosage being used in this study has been licensed for medical use by Health Canada for those with osteoporosis and for those at risk of getting osteoporosis. However, the use of the medication in this study is considered investigational because it has not been approved in people starting HIV treatment.

Participants will be followed a total of 48 weeks (just under one year). In addition to the first (baseline) visit, which will last between 60-90 minutes, there will also be a study visit halfway through the study (at 24 weeks) and at the end of the study (at 48 weeks), each lasting about 30-60 minutes. Participants assigned to receive the study medication will also have a short study visit (no more than 30 minutes) four weeks after starting the study medication.

During the study visits, research staff will gather medical history, measure height, weight, and hand strength, and provide several questionnaires about physical activity and response to the medication. Blood samples will also be taken to check and monitor CD4 cell count, calcium and phosphate levels, kidney function, hormone levels, inflammatory markers, and a blood count. A bone density scan will also be done at the Toronto General Hospital at the beginning (baseline), middle (24 weeks) and end of the study (48 weeks).

Results

Twenty-nine participants were included in this study. Researchers measured the bone density of participants’ spin and femur (thigh bone) after 48 weeks. They then compared the bone density of three groups: Patients who started taking the bone-building medication immediately when starting HIV treatment, patients who took the bone-building medication 6 months after beginning HIV treatment, and patients who did not take the bone-building medication at all. Those patients in the two groups who received the medication reported low levels of side-effects from the treatment, and were generally satisfied with how often they had to take the drugs. Overall, the results of the study suggested that the treatment did improve bone density in participants. The timing of the therapy was less important than whether or not the medication was taken at all, and there was no effect related to the type of antiretroviral therapy that participants were taking.

Conclusion

This pilot study suggests that taking the bone building medication alendronate with vitamin D could reduce bone weakening during HIV treatment. In particular, the medication might be even more effective if started six months after beginning HIV treatment. The data from this study helps researchers understand the variability in bone mineral density between participants and over time, helping them plan a larger clinical trial to test this intervention in more participants.