1. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand
- Author
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Thawee Songpatanasilp, Sattaya Rojanasthien, Pansak Sugkraroek, Boonsong Ongphiphadhanakul, Lamar Robert, Chongchit Sripun Robert, Sirichai Luevitoonvechkij, and Arthur C. Santora
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Alendronate ,Osteoporosis ,Thailand ,Vitamin D ,Beta-CrossLaps (β-CTx) ,Sunlight exposure ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background It is generally believed that Thai people do not suffer from hypovitaminosis D because there is abundant sunlight throughout the year, and that taking vitamin D supplements could result in abnormally high levels of vitamin D. This is a Thai FDA-driven study to investigate this risk over a period of 26 weeks of taking alendronate sodium/vitamin D3 combination tablets. Methods Osteoporosis patients in Thailand were recruited to a multicenter, open-label, 6-month trial of oral alendronate sodium 70 mg/vitamin D3 5600 IU. Patients received study medication once a week for 26 weeks. Serum 25-hydroxyvitamin D (25(OH)D) and Beta-CrossLaps (β-CTx) levels were measured at baseline and 26 weeks. The primary endpoint was the proportion of patients with 25(OH)D ≥ 50 ng/mL at week 26; it was hypothesized that 26 weeks’ treatment would not result in 25(OH)D serum levels ≥ 50 ng/mL in > 7% of osteoporosis patients. Results One hundred ninety-eight patients were recruited. At baseline, 67.2% of the patients had 25(OH)D
- Published
- 2018
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