Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand
Autor: | Chongchit Sripun Robert, Boonsong Ongphiphadhanakul, Pansak Sugkraroek, Sattaya Rojanasthien, Sirichai Luevitoonvechkij, Lamar Robert, Arthur C. Santora, Thawee Songpatanasilp |
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Rok vydání: | 2018 |
Předmět: |
Male
Vitamin medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Osteoporosis Administration Oral 030209 endocrinology & metabolism Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Rheumatology Internal medicine medicine Vitamin D and neurology Clinical endpoint Humans Orthopedics and Sports Medicine 030212 general & internal medicine Vitamin D Adverse effect Aged Cholecalciferol Alendronate Bone Density Conservation Agents business.industry Beta-CrossLaps (β-CTx) Middle Aged Thailand medicine.disease Hypervitaminosis D Alendronate Sodium Treatment Outcome chemistry Drug Therapy Combination Female Sunlight exposure lcsh:RC925-935 business Research Article |
Zdroj: | BMC Musculoskeletal Disorders BMC Musculoskeletal Disorders, Vol 19, Iss 1, Pp 1-9 (2018) |
ISSN: | 1471-2474 |
DOI: | 10.1186/s12891-018-2309-y |
Popis: | 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 |
Databáze: | OpenAIRE |
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