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Changes in bone turnover markers after calcium-enriched milk supplementation in healthy postmenopausal women: a randomized, double-blind, prospective clinical trial

Palacios, Santiago MD, PhD1; Castelo-Branco, Camil MD, PhD2; Cifuentes, Isabel MD1; von Helde, Sueli MD1; Baró, Luis3; Tapia-Ruano, Concepción MD1; Menéndez, Carmen MD1; Rueda, Camilo MD1

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Objective: To assess the effect of calcium, phosphorus, lactose, and vitamin D fortified skimmed milk on biomarkers of bone turnover in healthy postmenopausal women.

Design: The design was of a prospective, double-blind, randomized, 6 months study. Eighty postmenopausal women (aged 49-71 y) were allocated in two groups receiving 750 mL/day of a fortified skimmed milk containing 1,200 mg of calcium and 5.7 μg of vitamin D (group A) or 900 mg of calcium and 5.7 μg of vitamin D (group B). Ultrasound bone mass measurements and biochemical markers of bone formation, serum bone-specific alkaline phosphatase (AP), and carboxi-terminal propeptide of type I procollagen (PICP) and of bone resorption, urinary excretion of pyridinoline (Pyr), deoxypyridinoline (D-Pyr), and urinary type I collagen cross-linked N-telopeptide (NTx) were performed at baseline and after 10 weeks and 6 months of follow-up.

Results: PICP levels showed a significant reduction during the study, but no differences were observed between groups (−18.47 ± 11.4 group A vs −14.42 ± 12.5 group B). Pyr levels decreased in group A (P<0.001), whereas no changes were detected in group B. At the end of the study, a significant difference (P<0.01) was detected between groups in Pyr (−23.66 ± 5.7 group Avs 3.465 ± 7.1 group B) and D-Pyr (−16.64 ± 1.6 group Avs 2.955 ± 2.1 group B). At the 6th month, serum 25OH vitamin D increased in group A and decreased in group B (P = 0.007). Additionally, no differences were observed between groups in bone mass and in the other bone markers. Body weight was unchanged for group A, whereas a significant increase was observed in group B.

Conclusions: The daily intake of 750 mL of enriched skimmed milk containing 1,200 mg of calcium appears to be a useful, safe, and acceptable measure to calcium supplementation in healthy elderly postmenopausal women.

The daily intake of 750 ml of enriched skim milk containing 1,200 mg of calcium appears to be a useful, safe, and acceptable measure to calcium supplementation in healthy, elderly postmenopausal women.

From 1Institute Palacios of Woman's Health, Madrid; 2Institut Clínic de Ginecologia, Obstetrícia I Neonatologia, Hospital Clínic, IDIBAPS, Faculty of Medicine, University of Barcelona; and 3Department of Research and Development, Puleva S.A., Granada, Spain.

Received January 5, 2003; revised and accepted March 31, 2004.

Address correspondence to: Dr Camil Castelo-Branco, Institut Clínic de Ginecologia, Obstetrícia I Neonatologia, Hospital Clinic, Villarroel 170, 08036-Barcelona, Spain. E-mail: castelo@medicina.ub.es.

©2005The North American Menopause Society