ITM-058 Phase 3 study
Phase 3
Completed
- Conditions
- Osteoporosis
- Registration Number
- JPRN-jRCT2080223520
- Lead Sponsor
- Teijin Pharma Limited
- Brief Summary
The percent change in lumbar (L1-L4) bone mineral density at the last visit, the abaloparatide group is statistically significant increases to compared to the placebo group in both the entire population of postmenopausal osteoporosis patients and male osteoporosis patients and the subpopulation of postmenopausal osteoporosis patients. There were no clinically relevant findings or new safety concerns regarding safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 213
Inclusion Criteria
Patients with osteoporosis at high risk of fracture
Exclusion Criteria
Patients who may be affected by the secondary osteoporosis
Patients who were treated with the drugs that may affect Calcium levels or bone metabolism
Patients with a history of osteosarcoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Percent change in lumber spine BMD at the last visit
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Percent change in Hip BMD<br>Incidence of new vertebral fractures<br>Percent changes in bone metabolism markers<br>Evaluation of the quality of life (QOL)(SF-36v2TM, RDQ)<br>Safety