Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures

被引：0

作者：

Shiraki, Masataka ^{[1
]}

Kuroda, Tatsuhiko ^{[2
]}

Miyakawa, Nobuaki ^{[2
]}

Fujinawa, Naohito ^{[3
]}

Tanzawa, Kazumasa ^{[4
]}

Ishizuka, Akiko ^{[5
]}

Tanaka, Shiro ^{[6
]}

Tanaka, Yukari ^{[7
]}

Hosoi, Takayuki ^{[8
]}

Itoi, Eiji ^{[9
]}

Morimoto, Shigeto ^{[10
]}

Itabashi, Akira ^{[11
]}

Sugimoto, Toshitsugu ^{[12
]}

Yamashita, Toshihiko ^{[13
]}

Gorai, Itsuo ^{[14
]}

Mori, Satoshi ^{[15
]}

Kishimoto, Hideaki ^{[16
]}

Mizunuma, Hideki ^{[17
]}

Endo, Naoto ^{[18
]}

Nishizawa, Yoshiki ^{[19
]}

Takaoka, Kunio ^{[20
]}

Ohashi, Yasuo ^{[21
]}

Ohta, Hiroaki ^{[22
]}

Fukunaga, Masao ^{[23
]}

Nakamura, Toshitaka ^{[24
]}

Orimo, Hajime ^{[25
]}

机构：

[1] Res Inst & Practice Involut Dis, Dept Internal Med, Nagano 3998101, Japan

[2] Publ Hlth Res Fdn, Tokyo, Japan

[3] Icros Co Ltd, Tokyo, Japan

[4] ING Corp, Tokyo, Japan

[5] Japan Clin Res Support Unit, Tokyo, Japan

[6] Kyoto Univ, Translat Res Ctr, Div Clin Trial Design & Management, Kyoto, Japan

[7] Univ Tokyo, Sch Hlth Sci & Nursing, Dept Epidemiol & Biostat, Tokyo, Japan

[8] Natl Ctr Geriatr & Gerontol, Dept Adv Med, Aichi, Japan

[9] Tohoku Univ, Sch Med, Dept Orthopaed Surg, Sendai, Miyagi 980, Japan

[10] Kanazawa Med Univ, Kanazawa, Ishikawa, Japan

[11] Kubojima Clin, Saitama Ctr Bone Res, Saitama, Japan

[12] Shimane Univ, Fac Med, Dept Endocrinol & Metab, Matsue, Shimane, Japan

[13] Sapporo Med Univ, Sch Med, Dept Orthopaed Surg, Sapporo, Hokkaido, Japan

[14] Int Univ Hlth & Welf, Dept Obstet & Gynecol, Atami Hosp, Shizuoka, Japan

[15] Seirei Hamamatsu Gen Hosp, Shizuoka, Japan

[16] San In Rosai Hosp, Dept Orthoped Surg, Tottori, Japan

[17] Hirosaki Univ, Sch Med, Dept Obstet & Gynecol, Aomori, Japan

[18] Niigata Univ, Med & Dent Hosp, Div Orthoped Surg, Niigata, Japan

[19] Osaka City Univ, Grad Sch Med, Dept Metab Endocrinol & Mol Med, Osaka 558, Japan

[20] Osaka City Univ, Sch Med, Dept Orthopaed Surg, Osaka 545, Japan

[21] Univ Tokyo, Sch Publ Hlth, Dept Biostat, Tokyo, Japan

[22] Tokyo Womens Med Univ, Dept Obstet & Gynecol, Tokyo, Japan

[23] Kawasaki Med Sch, Dept Nucl Med, Okayama, Japan

[24] Univ Occupat & Environm Hlth, Sch Med, Dept Orthoped Surg, Kokura, Japan

[25] Hlth Sci Univ, Yamanashi, Japan

来源：

JOURNAL OF BONE AND MINERAL METABOLISM | 2011年 / 29卷 / 01期

关键词：

Alendronate; Alfacalcidol; Concurrent treatment; Fracture prevention; Osteoporosis; VERTEBRAL FRACTURE; POSTMENOPAUSAL OSTEOPOROSIS; JAPANESE PATIENTS; BONE-RESORPTION; ALENDRONATE; WOMEN; RISK; REDUCTION; INTERVENTION; PREVALENT;

D O I：

10.1007/s00774-010-0188-x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The aim of osteoporosis treatment is to prevent future fractures. Although concurrent treatment has been used very frequently for osteoporosis in clinical practice, there are no data on accurate and verified effectiveness of concurrent treatment for fracture prevention in patients with osteoporosis. To clarify the clinical usefulness of concurrent treatment, the Japan Osteoporosis Society has authorized the establishment of the A-TOP (Adequate Treatment of Osteoporosis) research group. The objective of this research is to establish a design for a clinical trial to prove whether concurrent treatment using both alfacalcidol (1-alpha-hydroxycholecalciferol) and alendronate is more effective as compared to treatment using alendronate alone in terms of fracture prevention. The present study was named JOINT (Japanese Osteoporosis Intervention Trial) and is based on a method using national, prospective, randomized, open-labeled, blinded endpoints focusing on postmenopausal osteoporosis with a high risk for fracture. The patients were mainly selected by practitioners and allocated randomly by a central registration system into two groups, of which one received 5 mg/day of alendronate alone, and the other received 1 mu g/day of 1-alpha-hydroxycholecalciferol (alfacalcidol) in addition to the alendronate. The endpoints focused primarily on fracture prevention, and the patients' quality of life (QOL) and change in body height, as well as adherence and the adverse events of the treatments were evaluated secondarily. To obtain sufficient statistical power in the events during a 2-year observation period, the patients who are expected to have higher risk were selected to participate in this study, and it was decided that the final plan would involve 890 patients per group (two-sided alpha = 0.05, power = 0.8). Data collection began in November 2003. Correspondence regarding the registration of the investigator and the progress of the study was conducted through a web system from the Public Health Research Foundation to practitioners.

引用

页码：37 / 43

页数：7

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