NIPH Clinical Trials Search

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 complete
Health condition(s) or Problem(s) studied	Osteoporosis
Date of first enrollment	2003/11/01
Target sample size	2140
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	alendronate(2years) alendronate+active vitaminD3(2years)

Outcome(s)

Primary Outcome	Incident vertebral fracture rate
Secondary Outcome	Period of incident vertebral fracture, non-vertebvral fracture rate, bone mineral density, QOL, Sreum vitamin D, safety

Key inclusion & exclusion criteria

Age minimum	70years-old
Age maximum	Not applicable
Gender	Female
Include criteria
Exclude criteria	Bone 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