Original article Effects on bone mineral density of calcium and vitamin D supplementation in elderly women with vitamin D deficiency Franck Grados a , Michel Brazier b , Saïd Kamel b , Sigolène Duver c , Nathalie Heurtebize c , Mohamed Maamer c , Marc Mathieu c , Michèle Garabédian d , Jean-Luc Sebert a , Patrice Fardellone a, * a Rheumatology Department, North Hospital Group, 80054 Amiens cedex 1, France b Endocrine and Bone Biology Laboratory, South Hospital Group, 80054 Amiens cedex 1, France c Laboratoires Innothéra, 94110 Arcueil, France d CNRS UPR 1524, Saint Vincent de Paul Teaching Hospital, 75000 Paris, France Received 10 May 2002; accepted 7 October 2002 Abstract Objectives. – Calcium and vitamin D deficiency is common in older individuals, particularly those who live in nursing homes, and increases the risk of osteoporosis and fractures. Methods. – We conducted a randomized double-blind placebo-controlled study of combined supplementation with 500 mg of elemental calcium, as carbonate, and 400 IU of vitamin D bid for 12 months in women older than 65 years of age with vitamin D deficiency, defined as serum 25(OH)D concentrations ≤12 ng/ml. Results. – Mean patient age was 75 ± 7 years, and median daily dietary intakes of calcium and vitamin D were 697 mg and 66.8 IU in the supplemented group (n = 95) and 671 mg and 61.8 IU in the placebo group (n = 97). The median serum 25(OH)D level was 7.0 ng/ml in both groups, and the medial intact parathyroid hormone (PTHi) levels were 49 and 48 pg/ml in the supplemented and placebo groups, respectively. The median increase in serum 25(OH)D was 22.0 ng/ml in the supplemented group and 4 ng/ml in the placebo group (P < 0.0001), and the median PTHi decrease was 17 and 5 pg/ml, respectively (P < 0.0001). The median bone mineral density increase was significantly greater in the supplemented group than in the placebo group: +2.98% vs. –0.21% at L2-L4 (P = 0.0009), +1.19% and –0.83% at the femoral neck (P = 0.015), +0.86% and –0.56% at the trochanter (P = 0.015), and +0.99% and +0.11% for the whole body (P = 0.01). Similarly, the median decrease in the main bone markers was significantly greater in the treated group than in the placebo group: –1.35 μg/l vs. +0.50 μg/l for bone alkaline phosphatase (P = 0.008), –16.6 nmol/mmol creatinine vs. –2.3 nmol/mmol creatinine for urinary type I amino-terminal telopeptide (P = 0.001), and –896 pmol/l vs. –201 pmol/l for serum type I carboxy-terminal telopeptide (P = 0.003). We found no significant differences between the two groups for serum calcium, although urinary calcium excretion changed more in the supplemented group than in the placebo group. In conclusion, bone mass in older women with vitamin D deficiency increases significantly at the lumbar spine, femur, trochanter, and whole body after calcium and vitamin D supplementation for 1 year, and concomitantly bone markers improved as vitamin D levels returned to normal. © 2003 Published by E ´ ditions scientifiques et médicales Elsevier SAS. Keywords: Vitamin D deficiency; Calcium-vitamin D supplementation; Bone mineral density; Bone turnover 1. Introduction Age-related bone loss contributes to the fracture risk in both men and women. Nutritional factors make a large con- tribution to age-related bone loss [1]. Vitamin D deficiency is common in older individuals as a result of limited exposure to sunlight and a low dietary intake in vitamin D [2,3]. With advancing age, conversion of 25(OH)D 3 to 1,25(OH) 2 D 3 decreases, resulting in a reduction in intestinal calcium ab- sorption [4,5], which adds to the effects of the often low dietary calcium intake [6]. The calcium and vitamin D defi- ciency stimulates the production of parathyroid hormone, which accelerates bone turnover [7], thereby causing bone loss. The result is an increased risk of fractures of the proxi- mal femur, which are a major source of morbidity and mor- * Corresponding author. E-mail address: fardellone.patrice@chu-amiens.fr (P. Fardellone). Joint Bone Spine 70 (2003) 203–208 www.elsevier.com/locate/bonsoi © 2003 Published by E ´ ditions scientifiques et médicales Elsevier SAS. DOI: 10.1016/S1297-319X(03)00046-0