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Bone mass preservation with high-dose cholecalciferol and dietary calcium in HIV patients following antiretroviral therapy. Is it possible?
HIV Clin Trials 2018; 19(5):188-196HC

Abstract

OBJECTIVE

To evaluate whether treatment with 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation in HIV patients following different cART regimens yields normal levels of vitamin D3 and PTH as well as whether changes in bone mineral density are clinically significant.

METHODS

Consecutive HIV patients following different cART regimens received 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation. The participants underwent BMD assessment via dual energy X-ray absorptiometry of the spine and hip at baseline (T0) and after 24 months (T1). Levels of 25(OH) vitamin D3 and parathyroid hormone (PTH) were assessed at T0 and T1. Quantitative variables were assessed with a paired t-test, independent t-test or analysis of variance, as appropriate. A chi-squared analysis was used to assess the association between qualitative variables. A p-value <0.05 was considered significant. Patients were divided into three groups depending on the cART regimen.

RESULTS

A total of 79 patients were included (40 males, 51% and 39 females, 49%), with a mean age of 46.6 (SD ±11.2) years, a baseline CD4 count of 649 cells/µl and a mean 25 hydroxycholecalciferol (25(OH) D3) value of 25 + 10 ng/ml. After 24 months, the 25(OH) D3 increased to 40 + 11 ng/ml. The initial BMDs at T0 were estimated as 0.919 (±0.27) and 0.867 (±0.14) g/cm2 at the spine and hip, respectively. After 24 months, the BMD was 0.933 (±0.15) g/cm2 at the spine and 0.857 (±0.14) g/cm2 at the hip. Based on a BMD change exceeding 3%, a worsening was observed in 23% of patients at the spine and 27% at the hip, whereas stability or improvement was demonstrated in 77% of patients at the spine and 73% at the hip. Subgrouping patients based on antiretroviral therapy indicated that, at T1, there was a statistically significant increase in vitamin D3 concentration in all patients, while PTH concentration was not significantly reduced in patients taking tenofovir or efavirenz. BMD stability or improvement was demonstrated in 77% of patients at the spine and 73% at the hip after 24 months. The multivariate analysis confirms a decrease in vitamin D3 and an increase in PTH levels in smokers, as well higher vitamin D3 concentrations in males and lower spine BMDs in menopausal females.

CONCLUSION

The proposed protocol of cholecalciferol and dietary calcium supplementation is safe and valid for correcting vitamin D abnormalities in almost all patients as well as reducing PTH levels in a high percentage of patients; however, it is not sufficient for normalization, particularly in patients exposed to tenofovir or efavirenz. At the spine, no significant BMD change was found in any of the therapy groups. At the hip, our data confirm a modest negative effect on bone mass caused by tenofovir and efavirenz.

Authors+Show Affiliations

a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.b University Hospital , Cagliari , Italy.c Clinical and Interventional Radiology Department , Western General Hospital Royal Victoria , Edinburgh , UK.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.b University Hospital , Cagliari , Italy.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.b University Hospital , Cagliari , Italy.a Department of Medical Sciences and Internal Medicine , University Hospital, University of Cagliari , Cagliari , Italy.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

30445888

Citation

Mela, Quirico, et al. "Bone Mass Preservation With High-dose Cholecalciferol and Dietary Calcium in HIV Patients Following Antiretroviral Therapy. Is It Possible?" HIV Clinical Trials, vol. 19, no. 5, 2018, pp. 188-196.
Mela Q, Ruggiero V, Montaldo L, et al. Bone mass preservation with high-dose cholecalciferol and dietary calcium in HIV patients following antiretroviral therapy. Is it possible? HIV Clin Trials. 2018;19(5):188-196.
Mela, Q., Ruggiero, V., Montaldo, L., Pisano, U., Matta, L., Maria Pasetto, C., ... Chessa, L. (2018). Bone mass preservation with high-dose cholecalciferol and dietary calcium in HIV patients following antiretroviral therapy. Is it possible? HIV Clinical Trials, 19(5), pp. 188-196. doi:10.1080/15284336.2018.1525841.
Mela Q, et al. Bone Mass Preservation With High-dose Cholecalciferol and Dietary Calcium in HIV Patients Following Antiretroviral Therapy. Is It Possible. HIV Clin Trials. 2018;19(5):188-196. PubMed PMID: 30445888.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bone mass preservation with high-dose cholecalciferol and dietary calcium in HIV patients following antiretroviral therapy. Is it possible? AU - Mela,Quirico, AU - Ruggiero,Valeria, AU - Montaldo,Lorenza, AU - Pisano,Umberto, AU - Matta,Laura, AU - Maria Pasetto,Cristina, AU - Onali,Simona, AU - Cacace,Enrico, AU - Carta,Mauro Giovanni, AU - Barca,Lucia, AU - Chessa,Luchino, Y1 - 2018/11/16/ PY - 2018/11/18/pubmed PY - 2019/5/1/medline PY - 2018/11/18/entrez KW - HIV KW - antiretroviral therapy KW - bone mass KW - cholecalcipherol KW - dietary calcium SP - 188 EP - 196 JF - HIV clinical trials JO - HIV Clin Trials VL - 19 IS - 5 N2 - OBJECTIVE: To evaluate whether treatment with 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation in HIV patients following different cART regimens yields normal levels of vitamin D3 and PTH as well as whether changes in bone mineral density are clinically significant. METHODS: Consecutive HIV patients following different cART regimens received 100,000 IU/month (equivalent to 3200 IU/day) of cholecalciferol and 1 g/day of dietary calcium supplementation. The participants underwent BMD assessment via dual energy X-ray absorptiometry of the spine and hip at baseline (T0) and after 24 months (T1). Levels of 25(OH) vitamin D3 and parathyroid hormone (PTH) were assessed at T0 and T1. Quantitative variables were assessed with a paired t-test, independent t-test or analysis of variance, as appropriate. A chi-squared analysis was used to assess the association between qualitative variables. A p-value <0.05 was considered significant. Patients were divided into three groups depending on the cART regimen. RESULTS: A total of 79 patients were included (40 males, 51% and 39 females, 49%), with a mean age of 46.6 (SD ±11.2) years, a baseline CD4 count of 649 cells/µl and a mean 25 hydroxycholecalciferol (25(OH) D3) value of 25 + 10 ng/ml. After 24 months, the 25(OH) D3 increased to 40 + 11 ng/ml. The initial BMDs at T0 were estimated as 0.919 (±0.27) and 0.867 (±0.14) g/cm2 at the spine and hip, respectively. After 24 months, the BMD was 0.933 (±0.15) g/cm2 at the spine and 0.857 (±0.14) g/cm2 at the hip. Based on a BMD change exceeding 3%, a worsening was observed in 23% of patients at the spine and 27% at the hip, whereas stability or improvement was demonstrated in 77% of patients at the spine and 73% at the hip. Subgrouping patients based on antiretroviral therapy indicated that, at T1, there was a statistically significant increase in vitamin D3 concentration in all patients, while PTH concentration was not significantly reduced in patients taking tenofovir or efavirenz. BMD stability or improvement was demonstrated in 77% of patients at the spine and 73% at the hip after 24 months. The multivariate analysis confirms a decrease in vitamin D3 and an increase in PTH levels in smokers, as well higher vitamin D3 concentrations in males and lower spine BMDs in menopausal females. CONCLUSION: The proposed protocol of cholecalciferol and dietary calcium supplementation is safe and valid for correcting vitamin D abnormalities in almost all patients as well as reducing PTH levels in a high percentage of patients; however, it is not sufficient for normalization, particularly in patients exposed to tenofovir or efavirenz. At the spine, no significant BMD change was found in any of the therapy groups. At the hip, our data confirm a modest negative effect on bone mass caused by tenofovir and efavirenz. SN - 1945-5771 UR - https://www.unboundmedicine.com/medline/citation/30445888/Bone_mass_preservation_with_high_dose_cholecalciferol_and_dietary_calcium_in_HIV_patients_following_antiretroviral_therapy__Is_it_possible L2 - http://www.tandfonline.com/doi/full/10.1080/15284336.2018.1525841 DB - PRIME DP - Unbound Medicine ER -