title: Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures: rationale, aims and organization of a Japanese Osteoporosis Intervention Trial (JOINT) initiated by the Research Group of Adequate Treatment of Osteoporosis (A-TOP).
abstract: 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 μg/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.
authors.affiliation: Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, 1610-1 Meisei, Misato, Azumino, Nagano, Japan. ripid@fc4.so-net.ne.jp
authors.forename: Masataka
authors.initials: M
authors.lastname: Shiraki
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Kuroda
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Miyakawa
authors.forename: Naohito
authors.initials: N
authors.lastname: Fujinawa
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Tanzawa
authors.forename: Akiko
authors.initials: A
authors.lastname: Ishizuka
authors.forename: Shiro
authors.initials: S
authors.lastname: Tanaka
authors.forename: Yukari
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Takayuki
authors.initials: T
authors.lastname: Hosoi
authors.forename: Eiji
authors.initials: E
authors.lastname: Itoi
authors.forename: Shigeto
authors.initials: S
authors.lastname: Morimoto
authors.forename: Akira
authors.initials: A
authors.lastname: Itabashi
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Yamashita
authors.forename: Itsuo
authors.initials: I
authors.lastname: Gorai
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mori
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kishimoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Mizunuma
authors.forename: Naoto
authors.initials: N
authors.lastname: Endo
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Nishizawa
authors.forename: Kunio
authors.initials: K
authors.lastname: Takaoka
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ohta
authors.forename: Masao
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
authors.forename: Hajime
authors.initials: H
authors.lastname: Orimo
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D019386:Alendronate / Q000627:therapeutic use*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D006801:Humans; D006887:Hydroxycholecalciferols / Q000627:therapeutic use*; D007564:Japan; D010024:Osteoporosis / Q000188:drug therapy*; D058866:Osteoporotic Fractures / Q000517:prevention & control
chemical_list: D050071:Bone Density Conservation Agents; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate
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