New study data reported today at the 14th Conference on Retroviruses and Opportunistic Infections suggests that Fosamax® (alendronate) is a safe and effective treatment option for HIV-positive people with advanced osteopenia and osteoporosis. The data also indicates that improvement in the lumbar spine and hip bone mineral density (BMD) was significantly better for people who took Fosamax along with vitamin D and calcium when compared with the results for people who took vitamin D and calcium alone.
Bonus Coverage: AIDSmeds founder Peter Staley recently interviewed Dr. Donald Kotler, chief of gastroenterology at St. Luke's-Roosevelt Hospital in New York, and a longtime researcher of wasting, lipodystrophy, and metabolic problems in people with HIV. Double click below to hear more about Fosamax helping with bone loss in HIVers.
Osteoporosis and osteopenia are familiar terms to many older adults. A diagnosis of osteoporosis, a serious loss of bone mass, can bring on a lot of anxiety, as it generally means that a person's bones have become weaker and are more likely to break. And while a diagnosis of osteopenia, a less serious loss of bone, does not mean the same thing as an osteoporosis diagnosis, it can be of concern just the same. Unfortunately, many HIV-positive people – many of whom are younger than those who typically experience weakening bones – are learning that they, too, have osteopenia or osteoporosis.
Calcium and vitamin D have long been used as supplements to help prevent and treatment BMD loss. While calcium alone cannot prevent or cure osteoporosis, it plays an important role in maintaining bone health. Vitamin D is also vital, as it helps the small intestine to absorb calcium. It also slows the removal of calcium from the body by the kidneys. In other words, calcium and vitamin D work together to help maintain bone health.
Fosamax, a “bisphosphonate” that slows the process by which bone is broken down by the body, is approved by the U.S. Food and Drug Administration (FDA) for both the prevention and treatment of osteoporosis – but only in postmenopausal women (it is approved for treatment [but not prevention] of osteoporosis in men and premonopausal women). What hasn’t been established is its safety and effectiveness for the prevention and treatment of osteoporosis in HIV-positive patients.
ACTG 5163, conducted by the AIDS Clinical Trials Group, was designed to study the safety and effectiveness of taking calcium and vitamin D supplements twice daily with or without once-weekly Fosamax (70 mg) for the treatment of reduced BMD in people infected with HIV. Everyone who entered the study had evidence of reduced BMD, based on a dual-energy x-ray absorptiometry (DEXA) of the lower spine (t-score, for short). Upon entering the study, patients were assigned to take calcium and vitamin D plus Fosamax or to take calcium and vitamin D plus a placebo.
The study enrolled 82 people and followed the patients for 48 weeks. Seventy-eight patients completed the entire study.
Upon entering the study, 96% of subjects had CD4 cell counts above 200, and 91% had viral loads below 400. The mean screening lumbar spine t-score was -2.1 (advanced osteopenia): -1.95 in the placebo arm and -2.15 in the Fosamax arm.
Lumbar spine BMD increased by an average of 3.38% by week 48 in the Fosamax/calcium/vitamin D group. In the placebo/calcium/vitamin D group, lumbar spine BMD increased by an average of 1.10%. The difference in the average percent change in lumbar spine BMD between treatment groups was 2.29%. All of these reported differences were statistically significant, meaning that they weren’t due to chance.
Improvements in the BMDs of the hip and trochanter (tip of the thigh bone) were also greater in the Fosamax group compared to the placebo group.
No significant side effects were reported.
In conclusion, Fosamax combined with calcium and vitamin D supplementation is safe and efficacious for HIV-positive men and women with advanced osteopenia and osteoporosis. Even among the patients who didn’t use Fosamax, the use of calcium and vitamin D alone was associated with modest improvements in BMD.
Source:
McComsey G, Kendall M, Tebas P, et al. Alendronate with calcium and vitamin D supplementation is superior to calcium and vitamin D alone in the management of decreased bone mineral density in HIV-infected patients: Results of ACTG 5163 [Abstract 42]. 14th Conference on Retroviruses and Opportunistic Infections, Los Angeles, 2006.
