Clinical Benefit

» This 6-month, open study examined the biochemical effects of chewable tablets (Calcia) containing 500 mg elemental calcium and 400 IU vitamin D₃ (2 tablets/day) in 45 institutionalised, elderly, vitamin D-deficient patients¹

» The study showed that the mean serum concentrations of vitamin D significantly increased from baseline (5.6 ng/ml) to normal values of 33.2 ng/ml and 40.9 ng/ml after 3 months and 6 months, respectively (p<0.001 for both comparisons)¹

» Corrected (according to albumin) serum calcium concentrations significantly increased by 8.9% (p<0.001) during the trial although no patient developed hypercalcaemia¹

» In conclusion, calcium and vitamin D supplementation was effective in correcting vitamin D deficiency and the resultant increase in bone turnover¹

Adapted from Chapuy et al, with permission
¹ Chapuy MC et al. Biochemical effects of calcium and vitamin D supplementation in elderly, institutionalized, vitamin D-deficient patients. Rev Rhum (English Ed) 1996; 63: 135-140.

» In this study, the effects of three oral calcium/vitamin D₃ formulations and placebo on calcium metabolism were compared in 18 healthy male volunteers (aged 18-35 years)¹

» Subjects were randomised for 8 days to receive: two Calcia tablets(2x 500 mg elemental calcium and 400 IU vitamin D₃); two Ostram R tablets (2x 500 mg elemental calcium and 400 IU vitamin D₃); one Cacit vitamin D₃ sachet (1000 mg elemental calcium and 880 IU vitamin D₃); or placebo. Treatments were taken once daily at 8 am after an overnight fast, and PTH concentrations were determined from venous blood sampled before and at regular intervals up to 3 hours after ingestion¹

» All three calcium/vitamin D₃ formulations significantly decreased serum PTH concentrations compared with baseline on day 1 (p≤0.05), and on day 8 (p≤0.001). Although there was no significant difference between treatments, PTH concentrations were lowest with Calcia CalciumD₃¹

» Although this study involved healthy young men, the efficacy of Calcia in suppressing PTH has also been demonstrated by Chapuy et al.2 Good results were seen as early as 3 months after initiation of treatment in an elderly, institutionalised, vitamin D-deficient population²

Reproduced from Deroisy et al, with permission
¹ Deroisy R et al. Comparison of the short-term effects of three oral calcium-vitamin D formulations and placebo on calcium metabolism. Curr Ther Res Clin Exp 1998; 59: 370-378.

² Chapuy MC et al. Biochemical effects of calcium and vitamin D supplementation in elderly institutionalized, vitamin D-deficient patients. Rev Rhum (English Ed) 1996; 63: 135-140.

» This randomised, double-blind study examined the efficacy and safety of a once-daily tablet containing 500 mg elemental calcium, with or without 200 IU vitamin D₃ (Calcia), in 41 postmenopausal women for the treatment of low bone mineral density (BMD) and/or complaints of back or lumbar pain

» Twenty-one patients received one chewable calcium/vitamin D₃ tablet per day, and 20 patients received one chewable calcium tablet per day for 6 months

» BMD increased after 3 months by 1.35% and 1.67% for the calcium/vitamin D₃ group and the calcium alone group respectively, although the difference was statistically significant only for the group receiving calcium alone (p<0.05 compared with baseline)

» After 6 months BMD in both groups was still higher than it was at baseline, although it was lower than that observed at 3 months and no longer statistically significantly different to that before treatment. A further eight patients who did not receive any treatment had a decrease in BMD of 2.34% after 6 months

» In conclusion, both the calcium/vitamin D₃ tablets and the calcium alone tablets were safe and had similar efficacy in the treatment of osteoporosis

Reproduced with permission from Japanese Pharmacology & Therapeutics
¹ Urabe M, Kashiwagi T, Iwasa K, et al. The effect of calcium chewable tablets on the level of bone-salt on postmenopausal females. Jap Pharmacol Ther 1995; 23: 3126-3134.

» The effect of vitamin D and calcium supplementation on callus formation during healing of osteoporotic shoulder fractures was studied in a double- blind, placebo-controlled study in 30 osteoporotic women (aged 58-88 years)¹

» Patients received either 2 x 500 mg calcium/400 IU vitamin D₃ (Calcia) daily (n=16) or placebo (n=14) and were monitored for 12 weeks after fracture occurrence¹

» Both groups experienced statistically significant increases in BMD levels from baseline, with peak levels in week 6 (treatment group: p=0.00001; control: p=0.015). During week 0 to week 6, those in the treatment group experienced a significantly higher increase in BMD than those in the placebo group (16.8% vs 10.0%; p=0.028)¹

» It was concluded that Calcia increased callus formation and BMD during the healing process of the osteoporotic fracture¹

Reprinted from Bone 2001. ©2001 with permission from Elsevier
¹ Doetsch AM et al. The influence of vitamin D₃ and calcium on osteoporotic fracture healing in humans. Bone 2001; 28: S244.

» Calcia products are also indicated as adjunctive treatments to other osteoporosis treatments, such as bisphosphonates, HRT and SERMs

» There is evidence that the combined use of calcium with HRT has a beneficial effect on bone mass and the risk of fracture, compared with HRT alone

» A review of published clinical trials suggested that a high calcium intake potentiates the positive effect of oestrogen on bone mass at all skeletal sites¹

» A randomised, placebo-controlled study examined the effect of combined calcium 1500 mg/vitamin D₃ 800 IU and 17b-estradiol (0.5 mg) on bone turnover in women aged >70 years. An additive effect of low-dose oestrogen and calcium/vitamin D₃ on bone resorption was observed, but no effects were seen on bone formation²

» A prospective population-based cohort study showed that HRT, dairy calcium and being overweight protected against distal forearm fracture³

» Other studies have reported beneficial effects on bone density and/or risk of fracture with calcium/vitamin D in combination with either a bisphosphonate, SERM, or PTH^4-6

¹ Nieves JW et al. Calcium potentiates the effect of estrogen and calcitonin on bone mass: review and analysis. Am J Clin Nutr 1998; 67: 18-24.

² Prestwood KM et al. Low dose estrogen and calcium have an additive effect on bone resorption in older women. J Clin Endocrinol Metab 1999; 84: 179-183.

³ Honkanen et al. Risk factors for perimenopausal distal forearm fracture. Osteoporos Int 2000; 11: 265-270.

⁴ Bell NH et al. Alendronate increases bone mass and reduces bone markers in postmenopausal African-American women. J Clin Endocrinol Metab 2002; 87: 2792-2797.

⁵ Ettinger B et al. Reduction of vertebral risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999; 282: 637-645.