NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Primary Osteoporosis
Date of first enrollment	14/08/2009
Target sample size	320
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : JTT-305 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Percentile change in lumbar spine BMD
Secondary Outcome	Bone turnover markers

Key inclusion & exclusion criteria

Age minimum	>= 45age old
Age maximum	Not applicable
Gender	Female
Include criteria	- More than 5 years since menopause - < 70% of YAM at lumbar spine - < 80% of YAM at lumbar spine with one mild vertebral fracture
Exclude criteria	- Vertebral fractures on the 1st to 4th lumbar spine - History of drug use; 1) Strontium ranelate, anti-RANKL antibody preparations, or parathyroid hormone preparations 2) Bisphosphonates within 1 year of the screening visit