A phase III, double-blind, comparative study of NE-58095 (once-monthly formulation)
Phase 3
- Conditions
- Involutional osteoporosis
- Registration Number
- JPRN-jRCT2080220992
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
[Main inclusion criteria]
-Aged 50 years or older at the time of obtaining consent
-Female subjects must be at least 2 years postmenopausal (i.e., at least 2 years since last menstrual period)
Exclusion Criteria
[Main exclusion criteria]
-Secondary osteoporosis
-Presence of any disease that can decrease bone mass, except secondary osteoporosis
-Findings that can affect DXA measurements of mean lumbar spine bone mineral density
-Prior radiotherapy to the lumbar spine or pelvic region
-Planned dental extraction or other dental surgical procedures (including dental implants) to be performed during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean lumbar spine bone mineral density (BMD)
- Secondary Outcome Measures
Name Time Method