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Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial.
Ann Intern Med 2015; 162(12):815-24AIM

Abstract

BACKGROUND

Antiretroviral therapy initiation for HIV-1 infection is associated with 2% to 6% loss of bone mineral density (BMD).

OBJECTIVE

To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation.

DESIGN

48-week prospective, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT01403051).

SETTING

39 AIDS Clinical Trials Group units.

PATIENTS

Adults with antiretroviral therapy-naive HIV.

MEASUREMENTS

BMD by dual-energy x-ray absorptiometry, 25-hydroxyvitamin D levels, and other laboratory assessments.

RESULTS

165 eligible patients were randomly assigned (79 received vitamin D3 plus calcium and 86 received placebo). The study groups were well-balanced at baseline: 90% were men, 33% were non-Hispanic black, and the median CD4 count was 0.341 × 109 cells/L. At 48 weeks, the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group: Medians were -1.36% (interquartile range [IQR], -3.43% to 0.50%) and -3.22% (IQR, -5.56% to -0.88%), respectively (P = 0.004). Similar results were seen at the lumbar spine. At 48 weeks, 90% of patients achieved HIV-1 RNA levels less than 50 copies/mL. Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo: Median change was 61.2 nmol/L (IQR, 36.4 to 94.3) versus 1.7 nmol/L (IQR, -13.2 to 10.7) (P < 0.001). Overall, 103 patients (62%) reported 1 or more adverse event, with similar distribution between groups; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group.

LIMITATION

No international sites were included, and follow-up was only 48 weeks.

CONCLUSION

Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26075752

Citation

Overton, Edgar Turner, et al. "Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: a Randomized Trial." Annals of Internal Medicine, vol. 162, no. 12, 2015, pp. 815-24.
Overton ET, Chan ES, Brown TT, et al. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Ann Intern Med. 2015;162(12):815-24.
Overton, E. T., Chan, E. S., Brown, T. T., Tebas, P., McComsey, G. A., Melbourne, K. M., ... Yin, M. T. (2015). Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Annals of Internal Medicine, 162(12), pp. 815-24. doi:10.7326/M14-1409.
Overton ET, et al. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: a Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):815-24. PubMed PMID: 26075752.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. AU - Overton,Edgar Turner, AU - Chan,Ellen S, AU - Brown,Todd T, AU - Tebas,Pablo, AU - McComsey,Grace A, AU - Melbourne,Kathleen M, AU - Napoli,Andrew, AU - Hardin,William Royce, AU - Ribaudo,Heather J, AU - Yin,Michael T, PY - 2015/6/16/entrez PY - 2015/6/16/pubmed PY - 2015/8/26/medline SP - 815 EP - 24 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 162 IS - 12 N2 - BACKGROUND: Antiretroviral therapy initiation for HIV-1 infection is associated with 2% to 6% loss of bone mineral density (BMD). OBJECTIVE: To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation. DESIGN: 48-week prospective, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT01403051). SETTING: 39 AIDS Clinical Trials Group units. PATIENTS: Adults with antiretroviral therapy-naive HIV. MEASUREMENTS: BMD by dual-energy x-ray absorptiometry, 25-hydroxyvitamin D levels, and other laboratory assessments. RESULTS: 165 eligible patients were randomly assigned (79 received vitamin D3 plus calcium and 86 received placebo). The study groups were well-balanced at baseline: 90% were men, 33% were non-Hispanic black, and the median CD4 count was 0.341 × 109 cells/L. At 48 weeks, the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group: Medians were -1.36% (interquartile range [IQR], -3.43% to 0.50%) and -3.22% (IQR, -5.56% to -0.88%), respectively (P = 0.004). Similar results were seen at the lumbar spine. At 48 weeks, 90% of patients achieved HIV-1 RNA levels less than 50 copies/mL. Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo: Median change was 61.2 nmol/L (IQR, 36.4 to 94.3) versus 1.7 nmol/L (IQR, -13.2 to 10.7) (P < 0.001). Overall, 103 patients (62%) reported 1 or more adverse event, with similar distribution between groups; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group. LIMITATION: No international sites were included, and follow-up was only 48 weeks. CONCLUSION: Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/26075752/full_citation L2 - https://www.annals.org/article.aspx?doi=10.7326/M14-1409 DB - PRIME DP - Unbound Medicine ER -