Phase 2 Dose-Finding Study of JTT-305 in Patients with Primary Osteoporosis.
Phase 2
- Conditions
- Primary Osteoporosis
- Registration Number
- JPRN-jRCT2080220803
- Lead Sponsor
- JAPAN TABACCO INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 320
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method