Comparison of the Effects of Ossein-Hydroxyapatite Complex and Calcium Carbonate on Bone Metabolism in Women with Senile
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Clin Drug Investig 2011; 31 (12): 817-824 1173-2563/11/0012-0817/$49.95/0
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Comparison of the Effects of Ossein-Hydroxyapatite Complex and Calcium Carbonate on Bone Metabolism in Women with Senile Osteoporosis A Randomized, Open-Label, Parallel-Group, Controlled, Prospective Study Manel Ciria-Recasens,1 Josep Blanch-Rubio´,1 Mo´nica Coll-Batet,2 Marı´a del Pilar Lisbona-Pe´rez,1 Adolfo Dı´ez-Perez,3 Jordi Carbonell-Abello´,1 Jose´ Manasanch4 and Lluı´s Pe´rez-Edo1 1 Rheumatology Unit, Hospitales Universitarios del Mar y de la Esperanc¸a, Barcelona, Spain 2 Rheumatology Unit, Hospital de Mataro´, Mataro´, Barcelona, Spain 3 Internal Medicine, Hospital del Mar-IMIM-UAB, Barcelona, and RETICEF, Instituto Carlos III, Madrid, Spain 4 Pierre Fabre Ibe´rica S.A., Barcelona, Spain
Abstract
Background and Objective: Calcium and vitamin D supplementation is recommended in patients with osteopenia and osteoporosis. One group that could benefit from this treatment is women with senile osteoporosis. Two sources of supplementary calcium are ossein-hydroxyapatite complex (OHC) and calcium carbonate, but, to date, their comparative effects on bone metabolism have not been studied in women with senile osteoporosis. The objective of this study was to compare the effects of OHC and calcium carbonate on bone metabolism in women with senile osteoporosis. Methods: This was a randomized, open-label, parallel-group, controlled, prospective study to compare the effects of OHC (treatment group) and calcium carbonate (control group) on bone metabolism. Patients were included between 2000 and 2004 and followed up for a maximum of 3 years. The study was carried out at the bone metabolism unit of two university hospitals in Barcelona, Spain. Subjects were women aged >65 years with densitometric osteoporosis of the lumbar spine or femoral neck. The treatment group received open-label OHC (Osteopor) at a dose of two 830 mg tablets every 12 hours (712 mg elemental calcium per day). The control group received open-label calcium carbonate at a dose of 500 mg of elemental calcium every 12 hours (1000 mg elemental calcium per day). Both groups also received a vitamin D supplement (calcifediol 266 mg) at a dose of one vial orally every 15 days. Biochemical markers of bone remodelling (osteocalcin by electrochemiluminescence, tartrateresistant acid phosphatase using colorimetry) were measured at baseline and
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annually for 3 years. Bone mineral density (BMD) at the lumbar spine and femoral neck was also measured. Results: One hundred and twenty women were included (55 in the OHC group and 65 in the calcium carbonate group), of whom 54 completed 3 years of follow-up. Levels of serum osteocalcin increased to a greater extent in the OHC group compared with the calcium carbonate group (by a mean – SD of 0.84 – 3.13 ng/mL at year 2 and 1.86 – 2.22 ng/mL at year 3 in the OHC group compared with a mean – SD decrease of 0.39 – 1.39 ng/mL at year 2 and an increase of 0.31 – 2.51
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