Purpose: To evaluate the effects of alendronate, vitamin D, and calcium supplementation on bone metabolism and bone mineral density (BMD) in both HIV-infected men and women treated with highly active antiretroviral therapy (HAART). Method: We performed a 52-week prospective, multicenter, randomized, open-label clinical trial. Eligible participants were on stable HAART and had BMD values at the femoral neck or lumbar spine that corresponded to a t score less than -1. Patients were randomized to receive alendronate 70 mg weekly or no alendronate; calcium 1000 mg daily and vitamin D 500 IU daily were provided to all study recipients. Primary endpoint of the study was the change in bone metabolism evaluated by N-telopeptide of type 1 collagen and bone-specific alkaline phosphatase; the secondary endpoint was BMD variation. Results: 18 patients were randomized to the alendronate and 23 to the no-alendronate group (controls). The alendronate-treatment group compared to controls had a significant decrease in serum N-telopeptides, 1914 ± 1433.4 vs. 3967 ± 1650.5 pM/L (p = .005) after 1 year. Lumbar spine BMD increased by 4% in the alendronate group (p = .004) vs. 3.7% (p = .062) in controls, compared to baseline values. Femoral neck BMD decreased by 0.5% in the alendronate group (p = .05) and by 3.5% in the control group (p =.04). No between-groups differences for BMD were found (Δ lumbar-BMD 0.0351 ± 0.0406 in cases and 0.0356 ± 0.073 in controls [p = .977], Δ femoral-BMD -0.085 ± 0.160 in cases and -0.100 ± 0.165 in controls [p = .795]. Conclusion: Alendronate plus vitamin D and calcium was effective in reducing bone resorption. Alendronate improved lumbar BMD and minimized femoral BMD decrease after 52 weeks compared to treatment with vitamin D and calcium alone in patients on HAART with osteopenia/osteoporosis.
Given the few controversial data about the effect of highly active antiretroviral therapy (HAART) on bone mass in HIV patients, we investigated whether a relationship between osteopenia/osteoporosis risk and HAART exists. METHODS: In 172 HIV patients, 152 on HAART, 92 including and 60 not including protease inhibitors (PI), 20 naïve and 64 controls, we measured spine/femur bone mineral density (BMD) by DEXA, and assayed serum osteocalcin (O), bone alkaline phosphatase (BAP), 1,25(OH)2 D, parathormone (PTH), calcium (Ca) and urinary pyridinium cross-links (PYD & DPD). RESULTS: Following WHO BMD t-score criteria, osteopenia was ascertained in >35% of all HAART groups and in 30% of naive. Only HAART patients had osteoporosis, PI patients more frequently, significantly (p<0.03) in spine (21.7% vs 8.3%). Males, intravenous drug users and B-C stage patients have a higher risk for low bone mass. Mean t-score was significantly lower in both spine and femur and O and PYD & DPD higher in PI than non PI patients and controls; 1,25(OH)2 D was significantly lower in all HIV groups than controls, PI patients having the lowest values positively correlating with BMD and negatively with OC and PYD & DPD, and it decreased further in 27 non selected monitored patients continuing on HAART. PTH was higher and Ca lower in HAART patients than controls but not significantly, PTH negatively correlating with BMD. CONCLUSION: HAART could be associated with osteopenia, even osteoporosis, and it could aggravate the loss in bone mass due to HIV infection itself. We hypothesize that HAART may directly affect bone remodelling and/or may indirectly affect vitamin D metabolism.
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|Titolo:||Bone mass loss and vitamin D metabolism impairment in HIV patients receiving highly active antiretroviral therapy.|
|Autori interni:||MADEDDU, Giordano|
MURA, Maria Stella Anna
|Data di pubblicazione:||2004|
|Rivista:||THE QUARTERLY JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING|
|Appare nelle tipologie:||1.1 Articolo in rivista|