The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil): A postmarketing surveillance study in korean postmenopausal women with osteoporosis

Hee Won Suh, Hyun Ok Kim, Young Sik Kim, Sung Sunwoo, Jung Ah Lee, Hye Ree Lee, Byungsung Kim, Dae Hyun Kim, Youn Seon Choi, Yoo Seock Cheong, Keunsang Yum, Yun Jun Yang, Byung Yeon Yu, Chung Hwan Cho, Sat Byul Park, Dong Hyeok Shin

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 μg), and to identify factors associated with efficacy. Methods: A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement. Results: A total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ± 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia. Conclusion: Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.

Original languageEnglish
Pages (from-to)346-355
Number of pages10
JournalKorean Journal of Family Medicine
Volume33
Issue number6
DOIs
Publication statusPublished - 2012 Dec 1

Fingerprint

Alendronate
Calcitriol
Bone Density
Osteoporosis
Safety
Odds Ratio
Confidence Intervals
Therapeutics
Dyspepsia
Photon Absorptiometry
Family Physicians
Social Class
Abdominal Pain
Observational Studies
Maxmarvil
Spine
Calcium

Keywords

  • Alendronate
  • Calcitriol
  • Maxmarvil
  • Postmenopausal osteoporosis

ASJC Scopus subject areas

  • Family Practice

Cite this

The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil) : A postmarketing surveillance study in korean postmenopausal women with osteoporosis. / Suh, Hee Won; Kim, Hyun Ok; Kim, Young Sik; Sunwoo, Sung; Lee, Jung Ah; Lee, Hye Ree; Kim, Byungsung; Kim, Dae Hyun; Choi, Youn Seon; Cheong, Yoo Seock; Yum, Keunsang; Yang, Yun Jun; Yu, Byung Yeon; Cho, Chung Hwan; Park, Sat Byul; Shin, Dong Hyeok.

In: Korean Journal of Family Medicine, Vol. 33, No. 6, 01.12.2012, p. 346-355.

Research output: Contribution to journalArticle

Suh, HW, Kim, HO, Kim, YS, Sunwoo, S, Lee, JA, Lee, HR, Kim, B, Kim, DH, Choi, YS, Cheong, YS, Yum, K, Yang, YJ, Yu, BY, Cho, CH, Park, SB & Shin, DH 2012, 'The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil): A postmarketing surveillance study in korean postmenopausal women with osteoporosis', Korean Journal of Family Medicine, vol. 33, no. 6, pp. 346-355. https://doi.org/10.4082/kjfm.2012.33.6.390
Suh, Hee Won ; Kim, Hyun Ok ; Kim, Young Sik ; Sunwoo, Sung ; Lee, Jung Ah ; Lee, Hye Ree ; Kim, Byungsung ; Kim, Dae Hyun ; Choi, Youn Seon ; Cheong, Yoo Seock ; Yum, Keunsang ; Yang, Yun Jun ; Yu, Byung Yeon ; Cho, Chung Hwan ; Park, Sat Byul ; Shin, Dong Hyeok. / The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil) : A postmarketing surveillance study in korean postmenopausal women with osteoporosis. In: Korean Journal of Family Medicine. 2012 ; Vol. 33, No. 6. pp. 346-355.
@article{4e42b7949c5f48c38619ff13001c1de7,
title = "The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil): A postmarketing surveillance study in korean postmenopausal women with osteoporosis",
abstract = "Background: Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 μg), and to identify factors associated with efficacy. Methods: A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement. Results: A total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4{\%} ± 6.4{\%} (P < 0.05), and 167 (45.1{\%}) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95{\%} confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95{\%} CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia. Conclusion: Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.",
keywords = "Alendronate, Calcitriol, Maxmarvil, Postmenopausal osteoporosis",
author = "Suh, {Hee Won} and Kim, {Hyun Ok} and Kim, {Young Sik} and Sung Sunwoo and Lee, {Jung Ah} and Lee, {Hye Ree} and Byungsung Kim and Kim, {Dae Hyun} and Choi, {Youn Seon} and Cheong, {Yoo Seock} and Keunsang Yum and Yang, {Yun Jun} and Yu, {Byung Yeon} and Cho, {Chung Hwan} and Park, {Sat Byul} and Shin, {Dong Hyeok}",
year = "2012",
month = "12",
day = "1",
doi = "10.4082/kjfm.2012.33.6.390",
language = "English",
volume = "33",
pages = "346--355",
journal = "Korean Journal of Family Medicine",
issn = "2005-6443",
publisher = "Korean Academy of Family Medicine",
number = "6",

}

TY - JOUR

T1 - The efficacy and safety of a combined alendronate and calcitriol agent (maxmarvil)

T2 - A postmarketing surveillance study in korean postmenopausal women with osteoporosis

AU - Suh, Hee Won

AU - Kim, Hyun Ok

AU - Kim, Young Sik

AU - Sunwoo, Sung

AU - Lee, Jung Ah

AU - Lee, Hye Ree

AU - Kim, Byungsung

AU - Kim, Dae Hyun

AU - Choi, Youn Seon

AU - Cheong, Yoo Seock

AU - Yum, Keunsang

AU - Yang, Yun Jun

AU - Yu, Byung Yeon

AU - Cho, Chung Hwan

AU - Park, Sat Byul

AU - Shin, Dong Hyeok

PY - 2012/12/1

Y1 - 2012/12/1

N2 - Background: Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 μg), and to identify factors associated with efficacy. Methods: A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement. Results: A total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ± 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia. Conclusion: Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.

AB - Background: Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 μg), and to identify factors associated with efficacy. Methods: A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement. Results: A total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ± 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia. Conclusion: Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.

KW - Alendronate

KW - Calcitriol

KW - Maxmarvil

KW - Postmenopausal osteoporosis

UR - http://www.scopus.com/inward/record.url?scp=84872581285&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84872581285&partnerID=8YFLogxK

U2 - 10.4082/kjfm.2012.33.6.390

DO - 10.4082/kjfm.2012.33.6.390

M3 - Article

C2 - 23267425

AN - SCOPUS:84872581285

VL - 33

SP - 346

EP - 355

JO - Korean Journal of Family Medicine

JF - Korean Journal of Family Medicine

SN - 2005-6443

IS - 6

ER -