NIPH Clinical Trials Search

UMIN ID: C000000001

Registered date:01/07/2005

Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan - Multi-center Randomized Trial with Arendoronate and alfa-calcidol -

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedOsteoporosis
Date of first enrollment2003/11/01
Target sample size2140
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)alendronate(2years) alendronate+active vitaminD3(2years)


Primary OutcomeIncident vertebral fracture rate
Secondary OutcomePeriod of incident vertebral fracture, non-vertebvral fracture rate, bone mineral density, QOL, Sreum vitamin D, safety

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
Include criteriaosteoporosis, prevalent vertebral fracture number=<4, >=70year women, possible to walk alone, risk foctor number of incident vertebral fracture=>1,possible to answer QOL questionnaire
Exclude criteriaBone disease other than osteoporosis, having contraindication in using drugs, disfunction of communication of the intention, deformation of vertebra, hyperthyroidism, hyperparathyroidism, abnormal heart function, abnormal hepatic function, abnormal kidney function, taken bisphosponate within previous 6 months

Related Information


public contact
Address 1-1-7 Nishi-waseda, Shinjyuku-ku Tokyo, Japan Japan
Telephone 03-5287-2633
Affiliation Public health research foundation CSP-A-TOP
scientific contact
Name Hajime Orimo
Address Kawaguchiko-cho, tsuru-gun, Yamanashi, Japan Japan
Affiliation Health science university President