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Most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of protease inhibitors (PIs) have been published. The more evident finding with respect to this issue is the more pronounced decrease of bone mineral density (BMD) in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.
The prevalence of osteoporosis in HIV-infected patients could be more than three times greater compared with HIV-uninfected subjects, according to the results of a meta-analytical review of cross-sectional published studies. The analysis includes data from 884 HIV-infected patients and 654 HIV-uninfected controls. Sixty-seven percent of HIV population had reduced bone mineral density (BMD), of whom 15% had osteoporosis (OR of 6.4 and 3.7, respectively, compared with HIV-uninfected controls).
In the same meta-analysis, when authors evaluated the role of antiretroviral therapy (ART) on BMD, comparing 202 antiretroviral-naive with 824 ART-treated patients, patients on treatment had a 2.5-fold increased odds of prevalent reduced BMD and osteoporosis. And finally, when 410 non-protease inhibitor (PI)-treated HIV patients were compared with 791 patients receiving a PI-containing regimen, those on PIs had increased odds of reduced BMD and osteoporosis.
As well, other studies support data of an impaired BMD in HIV-infected patients after starting antiretroviral therapy. These results let us confirm that HIV itself and antiretroviral therapy contribute to decrease the BMD.
However, most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of PIs have been published. The more evident finding with respect to this issue is the more pronounced decrease of BMD in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abacavir | Experimental | Switch from tenofovir to abacavir |
|
| tenofovir | No Intervention | Follow same ART regimen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch from tenofovir to abacavir | Drug | Switch from tenofovir to abacavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | From baseline to week 48 | |
| t-score change | From baseline to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| viral load | Evolution from baseline to week 48 | |
| CD4 T lymphocytes count | Evolution from baseline to week 48 | |
| Resistance test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lluita contra la SIDA Foundation | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25125679 | Derived | Negredo E, Domingo P, Perez-Alvarez N, Gutierrez M, Mateo G, Puig J, Escrig R, Echeverria P, Bonjoch A, Clotet B. Improvement in bone mineral density after switching from tenofovir to abacavir in HIV-1-infected patients with low bone mineral density: two-centre randomized pilot study (OsteoTDF study). J Antimicrob Chemother. 2014 Dec;69(12):3368-71. doi: 10.1093/jac/dku300. Epub 2014 Aug 13. |
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| If virological failure occurs |
| Lipid parameters (total, HDL-, LDL-cholesterol and triglyceride levels) | Evolution from baseline to week 48 |
| Adverse Events | From baseline to week 48 |
| Barcelona |
| Barcelona |
| 08041 |
| Spain |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106538 | abacavir |
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