Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand
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 ri...
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doaj-41c467b42f8442aa901df8f2073f0a052020-11-24T21:56:45ZengBMCBMC Musculoskeletal Disorders1471-24742018-11-011911910.1186/s12891-018-2309-yOpen-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in ThailandThawee Songpatanasilp0Sattaya Rojanasthien1Pansak Sugkraroek2Boonsong Ongphiphadhanakul3Lamar Robert4Chongchit Sripun Robert5Sirichai Luevitoonvechkij6Arthur C. Santora7Phramongkutklao HospitalDepartment of Orthopedics, Faculty of Medicine, Chiang Mai UniversityBumrungrad International HospitalRamathibodi HospitalEco-Health-One Health Resource Center, Chiang Mai UniversityEco-Health-One Health Resource Center, Chiang Mai UniversityDepartment of Orthopedics, Faculty of Medicine, Chiang Mai UniversityMerck & Co., Inc.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 < 30 ng/mL; this declined to 34.4% by week 26. The mean 25(OH)D level improved from 27.8 ng/mL at baseline to 33.6 ng/mL at week 26. Five patients (2.69% of the full analysis set) had 25(OH)D levels ≥ 50 ng/mL at 26 weeks. The highest 25(OH)D level, 64.3 ng/mL, was observed in a patient whose baseline level was 102.2 ng/mL. The majority (62.9%) of the patients had optimal 25(OH)D levels (30–50 ng/mL). β-CTx levels were reduced by 57.7% after 26 weeks’ treatment. No clinically significant cases of hypercalcemia which could be associated with hypervitaminosis D were identified during physical examination, in vital signs, or in laboratory results. Overall, 73 patients (36.9%) reported at least one adverse event (AE), with 13 (6.6%) reporting drug-related AEs. Four patients discontinued due to AEs, two of which were drug-related. Serious AEs were reported for four patients, of which one was considered drug-related. Conclusions Oral alendronate sodium 70 mg plus vitamin D3 5600 IU once weekly had an acceptable safety profile in this study, and increased serum 25(OH)D and reduced β-CTx levels in osteoporosis patients. This treatment improved 25(OH)D levels, without causing abnormally high levels, after 26 weeks’ treatment. Trial registration Clinical Trials.gov NCT01437111, Registered September 19, 2011.http://link.springer.com/article/10.1186/s12891-018-2309-yAlendronateOsteoporosisThailandVitamin DBeta-CrossLaps (β-CTx)Sunlight exposure |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Thawee Songpatanasilp Sattaya Rojanasthien Pansak Sugkraroek Boonsong Ongphiphadhanakul Lamar Robert Chongchit Sripun Robert Sirichai Luevitoonvechkij Arthur C. Santora |
spellingShingle |
Thawee Songpatanasilp Sattaya Rojanasthien Pansak Sugkraroek Boonsong Ongphiphadhanakul Lamar Robert Chongchit Sripun Robert Sirichai Luevitoonvechkij Arthur C. Santora Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand BMC Musculoskeletal Disorders Alendronate Osteoporosis Thailand Vitamin D Beta-CrossLaps (β-CTx) Sunlight exposure |
author_facet |
Thawee Songpatanasilp Sattaya Rojanasthien Pansak Sugkraroek Boonsong Ongphiphadhanakul Lamar Robert Chongchit Sripun Robert Sirichai Luevitoonvechkij Arthur C. Santora |
author_sort |
Thawee Songpatanasilp |
title |
Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand |
title_short |
Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand |
title_full |
Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand |
title_fullStr |
Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand |
title_full_unstemmed |
Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand |
title_sort |
open-label study of treatment with alendronate sodium plus vitamin d in men and women with osteoporosis in thailand |
publisher |
BMC |
series |
BMC Musculoskeletal Disorders |
issn |
1471-2474 |
publishDate |
2018-11-01 |
description |
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 < 30 ng/mL; this declined to 34.4% by week 26. The mean 25(OH)D level improved from 27.8 ng/mL at baseline to 33.6 ng/mL at week 26. Five patients (2.69% of the full analysis set) had 25(OH)D levels ≥ 50 ng/mL at 26 weeks. The highest 25(OH)D level, 64.3 ng/mL, was observed in a patient whose baseline level was 102.2 ng/mL. The majority (62.9%) of the patients had optimal 25(OH)D levels (30–50 ng/mL). β-CTx levels were reduced by 57.7% after 26 weeks’ treatment. No clinically significant cases of hypercalcemia which could be associated with hypervitaminosis D were identified during physical examination, in vital signs, or in laboratory results. Overall, 73 patients (36.9%) reported at least one adverse event (AE), with 13 (6.6%) reporting drug-related AEs. Four patients discontinued due to AEs, two of which were drug-related. Serious AEs were reported for four patients, of which one was considered drug-related. Conclusions Oral alendronate sodium 70 mg plus vitamin D3 5600 IU once weekly had an acceptable safety profile in this study, and increased serum 25(OH)D and reduced β-CTx levels in osteoporosis patients. This treatment improved 25(OH)D levels, without causing abnormally high levels, after 26 weeks’ treatment. Trial registration Clinical Trials.gov NCT01437111, Registered September 19, 2011. |
topic |
Alendronate Osteoporosis Thailand Vitamin D Beta-CrossLaps (β-CTx) Sunlight exposure |
url |
http://link.springer.com/article/10.1186/s12891-018-2309-y |
work_keys_str_mv |
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