Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70%25 of cases this was combined with vitamin D supplements. However, only 24%25 took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6%25 in the ALN/D5600 group compared with 31.0%25 in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57%25 vs. -46%25, P < 0.001) and bone-specific alkaline phosphatase (-47%25 vs. -40%25, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9%25 vs. 3.9%25, P = 0.047) and the total hip (2.2%25 vs. 1.4%25, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3%25 vs. 36.9%25, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. © 2011 Springer Science%2bBusiness Media, LLC.
Alendronate; Bone mineral density; Bone turnover marker; Osteoporosis; Vitamin D alendronic acid; alendronic acid plus colecalciferol; alfacalcidol; alkaline phosphatase; amino terminal telopeptide; calcitriol; calcium; creatinine; ibandronic acid; raloxifene; risedronic acid; strontium ranelate; vitamin D; zoledronic acid; aged; article; bone density; bone turnover; controlled study; diarrhea; drug efficacy; drug fatality; drug safety; drug tolerability; drug withdrawal; falling; female; health care quality; heart atrium fibrillation; human; major clinical study; multicenter study; postmenopause osteoporosis; priority journal; protein urine level; randomized controlled trial; risk assessment; stomach ulcer; vitamin blood level; vitamin D deficiency; Accidental Falls; Aged; Aged, 80 and over; Alendronate; Algorithms; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diphosphonates; Drug Combinations; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Standard of Care; Vitamin D Deficiency
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients%27 personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70%25 of cases this was combined with vitamin D supplements. However, only 24%25 took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6%25 in the ALN/D5600 group compared with 31.0%25 in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57%25 vs. -46%25, P < 0.001) and bone-specific alkaline phosphatase (-47%25 vs. -40%25, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9%25 vs. 3.9%25, P = 0.047) and the total hip (2.2%25 vs. 1.4%25, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3%25 vs. 36.9%25, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. © 2011 Springer Science Business Media, LLC.
Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients%27 personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70%25 of cases this was combined with vitamin D supplements. However, only 24%25 took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6%25 in the ALN/D5600 group compared with 31.0%25 in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57%25 vs. -46%25, P < 0.001) and bone-specific alkaline phosphatase (-47%25 vs. -40%25, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9%25 vs. 3.9%25, P = 0.047) and the total hip (2.2%25 vs. 1.4%25, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3%25 vs. 36.9%25, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. © 2011 Springer Science%2bBusiness Media, LLC.
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