Alendronate, vitamin D and calcium are safe and effective treatment for HIV-associated bone loss

Researchers who conducted a study of 31 HIV-positive subjects on ART suffering from osteopenia or osteoporosis conclude that treatment with alendronate, vitamin D and calcium is safe and effective.

These bone conditions are frequent complications of HIV infection and/or its treatment and alendronate is the only bisphosphonate approved to treat them in men and women. Dr P Tebas and colleagues at Washington University, St Louis, conducted a 48 week prospective, randomised, open label study to evaluate the treatment on bone mineral density in HIV-positive patients.

Thirty-one subjects who had been on ART for at least six months and who had lumbar spine BMD t scores less than –0.1 were randomised to receive 70mg of alendronate (n=15) or not (n=16) weekly for 48 weeks. All subjects also received 1,000mg of calcium carbonate daily and 400IU vitamin D daily. The study was powered to detect 3% changes in bone mineral density (BMD) in the lumbar spine within arms. The researchers report that the increase in lumbar spine BMD was 5.2% at 48 weeks in the alendronate arm, compared with 1.3% in the non-alendronate arm.

These results were reflected in other sites in the body with the BMD in the neck being increased 2.4% on baseline in the alendronate arm, compared to 1.6% in the non-alendronate arm; and in the hip BMD being increased 2.3% in the alendronate arm compared with 1.7%. They report that there were no serious side effects.

Dr Tebas and colleagues conclude: “Alendronate, vitamin D and calcium are safe and effective in the treatment of osteopenia/osteoporosis associated with HIV infection… These results are consistent with the results observed in HIV individuals. These data provide the basis for sample size calculations and support the evaluation of alendronate in larger randomised trials.”

Comment

This is a short term study with low numbers, and although the results are very interesting this limits the conclusions on safety. When to treat is an important question. Routine monitoring of bone density in patients without fractures is currently limited by healthcare and insurance providers in many countries, but with prevalence of low BMD shown at 40-60% HIV-positive studies this will need timely reviewing.

Mondy K, Powderly W. Tebas P et al. Alendrolate, vitamin D and calcium for the treatment of osteopenia/osteoporosis associated with HIV infection. 10th CROI, 10–14 February 2003, Boston. Abstract 134.