Vitamin D insufficiency does not affect bone mineral density response to raloxifene

Diana M. Antoniucci, Eric Vittinghoff, Terri Blackwell, Dennis M. Black, Deborah E. Sellmeyer

Research output: Contribution to journalArticle

Abstract

Context: Vitamin D insufficiency and osteoporosis are common and often coexist in postmenopausal women. Objective: The objective of this study was to test whether the presence of vitamin D insufficiency at the initiation of raloxifene therapy affected the subsequent response of bone mineral density (BMD). Design, Setting, and Participants: We studied 7522 postmenopausal participants of the Multiple Outcomes of Raloxifene Evaluation, a placebo-controlled trial of the effects of raloxifene on BMD and fracture. Intervention: After enrollment, all participants began daily supplements of 500 mg calcium and 400-600 IU cholecalciferol; 1 month later, women were randomly assigned to placebo or raloxifene. Main Outcome Measure: Serum levels of vitamin D [25-hydroxy vitamin D (25OHD)] were measured at enrollment, randomization, and 6 months later. We categorized participants' vitamin D status (deficient, insufficient, or sufficient) based on their randomization 25OHD level. We estimated the effects of treatment on BMD within these subgroups using linear regression models. Results: At enrollment, 3.2% of participants were vitamin D deficient, and 51.8% were insufficient; after 7 months of cholecalciferol supplementation, 0.2% of all participants remained D deficient, and 23.6% remained insufficient. The effects of raloxifene on hip and spine BMD did not vary by vitamin D status at randomization (P = 0.08 and P = 0.7, respectively). Conclusion: We conclude that vitamin D status at initiation of raloxifene therapy does not affect the subsequent BMD response when coadministered with cholecalciferol and calcium. After 7 months of cholecalciferol therapy, very few women continued to have 25OHD levels in the deficient range; however, 25OHD levels remained sub-optimal in nearly one fourth of the cohort. Additional research is needed to determine whether these observations can be generalized to other antiresorptive agents.

Original languageEnglish (US)
Pages (from-to)4566-4572
Number of pages7
JournalJournal of Clinical Endocrinology and Metabolism
Volume90
Issue number8
DOIs
StatePublished - Aug 2005
Externally publishedYes

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Vitamin D
Bone Density
Minerals
Bone
Cholecalciferol
Random Allocation
Linear Models
Placebos
Pelvic Bones
Bone Density Conservation Agents
Calcium
Raloxifene Hydrochloride
Bone Fractures
Therapeutics
Linear regression
Osteoporosis
Spine
Outcome Assessment (Health Care)
Serum
Research

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Antoniucci, D. M., Vittinghoff, E., Blackwell, T., Black, D. M., & Sellmeyer, D. E. (2005). Vitamin D insufficiency does not affect bone mineral density response to raloxifene. Journal of Clinical Endocrinology and Metabolism, 90(8), 4566-4572. https://doi.org/10.1210/jc.2005-0290

Vitamin D insufficiency does not affect bone mineral density response to raloxifene. / Antoniucci, Diana M.; Vittinghoff, Eric; Blackwell, Terri; Black, Dennis M.; Sellmeyer, Deborah E.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 90, No. 8, 08.2005, p. 4566-4572.

Research output: Contribution to journalArticle

Antoniucci, DM, Vittinghoff, E, Blackwell, T, Black, DM & Sellmeyer, DE 2005, 'Vitamin D insufficiency does not affect bone mineral density response to raloxifene', Journal of Clinical Endocrinology and Metabolism, vol. 90, no. 8, pp. 4566-4572. https://doi.org/10.1210/jc.2005-0290
Antoniucci, Diana M. ; Vittinghoff, Eric ; Blackwell, Terri ; Black, Dennis M. ; Sellmeyer, Deborah E. / Vitamin D insufficiency does not affect bone mineral density response to raloxifene. In: Journal of Clinical Endocrinology and Metabolism. 2005 ; Vol. 90, No. 8. pp. 4566-4572.
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abstract = "Context: Vitamin D insufficiency and osteoporosis are common and often coexist in postmenopausal women. Objective: The objective of this study was to test whether the presence of vitamin D insufficiency at the initiation of raloxifene therapy affected the subsequent response of bone mineral density (BMD). Design, Setting, and Participants: We studied 7522 postmenopausal participants of the Multiple Outcomes of Raloxifene Evaluation, a placebo-controlled trial of the effects of raloxifene on BMD and fracture. Intervention: After enrollment, all participants began daily supplements of 500 mg calcium and 400-600 IU cholecalciferol; 1 month later, women were randomly assigned to placebo or raloxifene. Main Outcome Measure: Serum levels of vitamin D [25-hydroxy vitamin D (25OHD)] were measured at enrollment, randomization, and 6 months later. We categorized participants' vitamin D status (deficient, insufficient, or sufficient) based on their randomization 25OHD level. We estimated the effects of treatment on BMD within these subgroups using linear regression models. Results: At enrollment, 3.2{\%} of participants were vitamin D deficient, and 51.8{\%} were insufficient; after 7 months of cholecalciferol supplementation, 0.2{\%} of all participants remained D deficient, and 23.6{\%} remained insufficient. The effects of raloxifene on hip and spine BMD did not vary by vitamin D status at randomization (P = 0.08 and P = 0.7, respectively). Conclusion: We conclude that vitamin D status at initiation of raloxifene therapy does not affect the subsequent BMD response when coadministered with cholecalciferol and calcium. After 7 months of cholecalciferol therapy, very few women continued to have 25OHD levels in the deficient range; however, 25OHD levels remained sub-optimal in nearly one fourth of the cohort. Additional research is needed to determine whether these observations can be generalized to other antiresorptive agents.",
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