A Comparative Study between Pentoxifylline and Teriparatide for the treatment of Postmenopausal Osteoporosis
Phase 2
- Conditions
- Health Condition 1: E835- Disorders of calcium metabolism
- Registration Number
- CTRI/2020/08/027332
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Postmenopausal women
2. Age >40 years
3. BMD T score <-2.5
4. Willingness to participate
5. Treatment naive
Exclusion Criteria
1. Subjects with history of anti-osteoporotic treatment, hormonal replacement therapy
2. History of glucocorticoid treatment or supplement can influence BMD
3. High creatinine level
4. Unwillingness to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjects treated with PTX would have improved BMD and P1NP level than those treated with teriparatideTimepoint: Visit 1 screening visit Visit 2 Randomization Visit 3 Day 7 days; Visit 4 Wk 2 Day 14 Visit 5 Wk 3Day 21 days Visit 6 Wk 4Day 28 days Visit 7Wk 8 Day 56 days Visit 8Wk 12 Day 84 days Visit 9 Day 112 days Visit 10 Day 140 days
- Secondary Outcome Measures
Name Time Method Subjects treated with PTX would have better safety, tolerability with teriparatide. Additionally, PTX will also have a protective role for the optimization of overall bone health including fracture preventionTimepoint: Visit 1 screening visit Visit 2 Randomization Visit 3 Day 7 days; Visit 4 Wk 2 Day 14 Visit 5 Wk 3Day 21 days Visit 6 Wk 4Day 28 days Visit 7Wk 8 Day 56 days Visit 8Wk 12 Day 84 days Visit 9 Day 112 days Visit 10 Day 140 days