Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Teriparatide Injection IP 600 mcg/2.4 mL: Teriparatide Injection IP 600 mcg/2.4 mL, subject will self-administer 20 mcg from the injection into the thigh or abdominal wall once daily fo
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with at least 5 years of post menopause, aged > 50 to 80 years 2. Postmenopausal women with osteoporosis
Exclusion criteria
Exclusion criteria: 1. known hypersensitivity to teriparatide or any of its excipients 2. pre-existing hypercalcemia 3. severe renal impairment 4. metabolic bone diseases other than postmenopausal osteoporosis. 5. unexplained elevation of alkaline phosphatase 6. Prior external beam or implant radiation therapy to the skeleton. 7. patients with skeletal malignancies or bone metastases should be excluded from the treatment with teriparatide. 8. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of AEs and number of adverse reactionsTimepoint: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of serious adverse reaction and serious adverse drug reactions during the study period. 2. percentage change from baseline to week 24 in bone mineral density at lumbar spine and femoral neck 3. change in baseline in PD biomarkers and bone specific alkaline phosphatase at week 12 and week 24Timepoint: week 24 | — |
Countries
India
Contacts
Public ContactDr Dattatray Pawar
Alkem Laboratories Limited
Outcome results
None listed