Primary Osteoporosis
Conditions
Interventions
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 Investigatio
Sponsors
JAPAN TABACCO INC.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - More than 5 years since menopause - < 70% of YAM at lumbar spine - < 80% of YAM at lumbar spine with one mild vertebral fracture
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentile change in lumbar spine BMD | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone turnover markers | — |
Outcome results
None listed