Postmenopausal Women With Low Bone Mass
Postmenopausal Women With Low Bone Mass
Objective: To investigate the biological effects of supplementation with vitamin D and calcium versus supplementation with calcium alone during the first 3 months of treatment with alendronate in postmenopausal women with a risk of fracture and with vitamin D and calcium insufficiency.
Design: Randomised, double-blind trial.
Subjects: The study randomised 48 osteopenic and osteoporotic women, mean age 70 ± 6 years and at least 5 years after menopause, who were living at home. Inclusion criteria were low bone mineral density (more than 1 SD below reference value), serum 25-hydroxy-vitamin D3 (25-OHD, calcifediol) <12 µg/L and dietary calcium intake <1 g/day.
Methods: The women were divided into two groups. The first group (n = 23) received alendronate 10mg once daily supplemented with calcium and vitamin D (elemental calcium 500mg, colecalciferol [vitamin D3] 400IU) twice daily for 3 months. The second group (n = 25) received the same dosage of alendronate and a placebo with calcium alone (500 mg/day). Blood, serum and urine samples were obtained for measurement of calcaemia, intact parathyroid hormone (i-PTH) and markers of bone remodelling such as the N-and C-terminal telopeptides of type I collagen (NTX and CTX).
Results: Supplementation with calcium and vitamin D caused a rapid increase of 25-OHD levels without changes in calcaemia or i-PTH levels. In the two groups, serum and urinary CTX and urinary NTX were dramatically and significantly decreased after as little as 15 days of treatment and remained decreased throughout the course of treatment. No significant difference between the two treatments was observed, but the combined treatment resulted in a more pronounced effect as assessed by the Hodge-Lehman test, particularly after 1 month for the bone resorption markers serum CTX (p = 0.064) and urinary NTX (p = 0.076).
Conclusion: Supplementation with calcium and vitamin D could be appropriate in elderly women with calcium and vitamin D insufficiencies being treated with alendronate in order to achieve rapid reduction of bone remodelling.
Bone loss begins to occur more rapidly in women at the menopause. This change in bone density persists with aging, thereby contributing to osteoporosis and increased fracture risk in older women. Among the main factors identified as inducing osteoporosis, estrogen deficiency in women at the menopause and vitamin D plus calcium insufficiencies in the elderly are the most widely studied. The consequence of bone degradation is an increased risk of fracture at vertebral or wrist sites in postmenopausal women and at vertebral or femoral sites in the elderly. It has been shown that the prevalence of vitamin D and calcium insufficiencies increases in the aging population. Moreover, in elderly people living at home or in an institution, supplementation with vitamin D and calcium is effective in reducing loss of bone mass and bone remodelling, and consequently in decreasing the incidence of fracture.
Among the bisphosphonates, alendronate is one of the most powerful inhibitors of osteoclastic activity. It reduces bone mineral loss and does not produce qualitative alterations in mineralisation. Moreover, several studies have shown that alendronate 10 mg/day increases bone mass at all sites. Recently, the Fracture Intervention Trial (FIT) Research Group demonstrated a 50% reduction in the incidence of new vertebral and femoral fractures in subjects with pre-existing fractures. Currently, daily calcium supplementation providing 500mg of elemental calcium is recommended during the course of treatment with alendronate.
The main objective of the present study was to investigate the biological effects of supplementation with vitamin D and calcium (colecalciferol [vitamin D3] 400IU + calcium 500mg twice daily) versus supplementation with calcium alone (500 mg/day) in postmenopausal women with a risk of fracture and with vitamin D and calcium insufficiency during the first 3 months of treatment with alendronate.
Objective: To investigate the biological effects of supplementation with vitamin D and calcium versus supplementation with calcium alone during the first 3 months of treatment with alendronate in postmenopausal women with a risk of fracture and with vitamin D and calcium insufficiency.
Design: Randomised, double-blind trial.
Subjects: The study randomised 48 osteopenic and osteoporotic women, mean age 70 ± 6 years and at least 5 years after menopause, who were living at home. Inclusion criteria were low bone mineral density (more than 1 SD below reference value), serum 25-hydroxy-vitamin D3 (25-OHD, calcifediol) <12 µg/L and dietary calcium intake <1 g/day.
Methods: The women were divided into two groups. The first group (n = 23) received alendronate 10mg once daily supplemented with calcium and vitamin D (elemental calcium 500mg, colecalciferol [vitamin D3] 400IU) twice daily for 3 months. The second group (n = 25) received the same dosage of alendronate and a placebo with calcium alone (500 mg/day). Blood, serum and urine samples were obtained for measurement of calcaemia, intact parathyroid hormone (i-PTH) and markers of bone remodelling such as the N-and C-terminal telopeptides of type I collagen (NTX and CTX).
Results: Supplementation with calcium and vitamin D caused a rapid increase of 25-OHD levels without changes in calcaemia or i-PTH levels. In the two groups, serum and urinary CTX and urinary NTX were dramatically and significantly decreased after as little as 15 days of treatment and remained decreased throughout the course of treatment. No significant difference between the two treatments was observed, but the combined treatment resulted in a more pronounced effect as assessed by the Hodge-Lehman test, particularly after 1 month for the bone resorption markers serum CTX (p = 0.064) and urinary NTX (p = 0.076).
Conclusion: Supplementation with calcium and vitamin D could be appropriate in elderly women with calcium and vitamin D insufficiencies being treated with alendronate in order to achieve rapid reduction of bone remodelling.
Bone loss begins to occur more rapidly in women at the menopause. This change in bone density persists with aging, thereby contributing to osteoporosis and increased fracture risk in older women. Among the main factors identified as inducing osteoporosis, estrogen deficiency in women at the menopause and vitamin D plus calcium insufficiencies in the elderly are the most widely studied. The consequence of bone degradation is an increased risk of fracture at vertebral or wrist sites in postmenopausal women and at vertebral or femoral sites in the elderly. It has been shown that the prevalence of vitamin D and calcium insufficiencies increases in the aging population. Moreover, in elderly people living at home or in an institution, supplementation with vitamin D and calcium is effective in reducing loss of bone mass and bone remodelling, and consequently in decreasing the incidence of fracture.
Among the bisphosphonates, alendronate is one of the most powerful inhibitors of osteoclastic activity. It reduces bone mineral loss and does not produce qualitative alterations in mineralisation. Moreover, several studies have shown that alendronate 10 mg/day increases bone mass at all sites. Recently, the Fracture Intervention Trial (FIT) Research Group demonstrated a 50% reduction in the incidence of new vertebral and femoral fractures in subjects with pre-existing fractures. Currently, daily calcium supplementation providing 500mg of elemental calcium is recommended during the course of treatment with alendronate.
The main objective of the present study was to investigate the biological effects of supplementation with vitamin D and calcium (colecalciferol [vitamin D3] 400IU + calcium 500mg twice daily) versus supplementation with calcium alone (500 mg/day) in postmenopausal women with a risk of fracture and with vitamin D and calcium insufficiency during the first 3 months of treatment with alendronate.
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