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Comparison of Two Doses of Zoledronic Acid for the Treatment of Osteoporosis in HIV Infected Patients.
Results of a Randomized Open Label Study (VIHZOL Study)
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Reported by Jules Levin
CROI 204 March 3-6 Boston, MA
Eugenia Negredo1, Anna Bonjoch1, Nuria Perez-ēlvarez1,2, Arelly Ornelas1,3, Jordi Puig1, Cristina Herrero 1 , Patricia Echeverra1, Bonaventura Clotet1,4.
1 Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain. Universitat Autonoma de Barcelona, Spain.2 Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain. 3 Department of Econometrics, University of Barcelona, Barcelona, Spain. 4 Irsicaixa Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain.
Trias i Pujol University Hospital, Badalona, Spain. Universitat Autonoma de Barcelona, Spain.2 Statistics and Operations Research Department, Universitat Politecnica de Catalunya, Barcelona, Spain. 3 Department of Econometrics, University of Barcelona, Barcelona, Spain. 4 Irsicaixa Foundation, Germans Trias i Pujol University Hospital, Badalona, Spain. Address for correspondence: Eugenia Negredo, MD, PhD enegredo@flsida.org
Program Abstract
Background: An increasing proportion of HIV-infected patients need treatment for osteoporosis. The best management of this problem is not well-known.
Methodology: This is a randomized, controlled, pilot study to compare the benefit of a biennial use of zoledronic acid with the standard dosage, the annual
use, in HIV-infected patients with osteoporosis. A total of 31 caucasian subjects were randomized (2:1), 10 at Control group and 21 to Zoledronic group;
at week 48, subjects from the Zoledronic group were reallocated to Annual group (n= 12, 5 mg per year, 2 doses in 2 years) or Biennial group (n=9, one
dose in 2 years). Changes from baseline to week 96 in bone mineral density (BMD) for the lumbar spine (L1-L4) and total femur, determined by dualenergy
x-ray absorptiometry, were compared between groups, as well as changes in serum alkaline phosphatase, serum procollagen type 1 amino-terminal
propeptide (P1NP) and urine N-telopeptide of type 1 collagen (NTx). Mann-Whitney test was used to compare the percentage of change in BMD between
groups; McNemar test when the variables are categorical, and by Wilcoxon test in case of non normal variables were used for intragroup comparisons.
Results: At week 96, the percentage of change in hip BMD was 2.12% (-0.12; 3.08) in Control group, 5.16% (3.06;6.74) in Annual group and 4.47%
(1;5.58) in Biennial group (p=0.042 between Control and Annual group). Lumbar spine BMD decreased -1.74% (-2.56;3.60) in Control group, increased
7.90% (4.20;16.57) in Annual group and 5.22% (2.02;7.28) in Biennial group (p=0.003 between Control and Annual group; p=0.017 between Control
and Biennial group). NTx (p=0.006) and P1NP (p=0.005), significantly decreased in Annual group. Biennial group showed a significant decrease from
baseline to 48 week in P1NP (p=0.036), and a trend to significance in NTx (p=0.05), but not between baseline to week 96. No differences between
Annual and Biennial groups were detected in any parameter at week 96. Two patients from Zoledronic group suffered grade 1 asthenia and two had fever
within 48 hours after the infusion administration, one of them with grade 1 and other grade 2 of intensity. All symptoms reverted with paracetamol or
ibuprofen administration. No discontinuations of the study were observed due to adverse events drug-related.
Conclusions: The use of biennial zoledronic acid presented similar bone benefit than the annual administration after 96 weeks of follow up in terms of BMD
and bone markers. The biennial administration of zoledronic acid may be an alternative in the treatment of osteoporosis in this population.
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