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Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial.

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.

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    Source

    Annals of internal medicine 162:12 2015 Jun 16 pg 815-24

    MeSH

    Absorptiometry, Photon
    Adult
    Anti-Retroviral Agents
    Biomarkers
    Bone Density
    Bone Density Conservation Agents
    Bone Resorption
    Calcifediol
    Calcium Carbonate
    Dietary Supplements
    Double-Blind Method
    Female
    HIV Infections
    HIV-1
    Humans
    Male
    Middle Aged
    Osteoporosis
    Parathyroid Hormone
    Prospective Studies

    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 -