Health Condition 1: E835- Disorders of calcium metabolism
Conditions
Interventions
Intervention1: Teriparatide: A PTH analogue (1-34) amino acids used for the treatment of postmnopausal osteoporosis
Control Intervention1: Pentoxifylline: Pentoxifylline, also known as oxpentifylline,
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women 2. Age >40 years 3. BMD T score 4. Willingness to participate 5. Treatment naive
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactBhavuk Garg
AIIMS, New Delhi
Outcome results
None listed