Health Condition 1: null- Postmenopausal Osteoporosis
Conditions
Interventions
Intervention1: Teriparatide by Enzene Biosciences: 3 mL Cartridge contains 750 micrograms of Teriparatide, subject will self-administer 20 mcg from the injection into the thigh or abdominal wall once
Sponsors
Alkem Laboratories Limited
Enzene Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: I1. Women with at least 5 years postmenopause, aged > 50 to 80 years; I2. Have low bone mass determined by a bone density test (DXA), BMD T-scores I3. Women who are capable of understanding and giving written, voluntary informed consent for this study.
Exclusion criteria
Exclusion criteria: E1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DXA; E2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D E3. Subjects with primary hyperparathyroidism as indicated by serum levels of PTH > 65 pg/mL at screening; E4. Subjects with thyroid dysfunction; E5. Subjects with hypercalcemia; E6. Any previous treatment with bisphosphonates in the last 12 months prior to screening; E7. Previous treatment with any other drug affecting bone metabolism in the last 3 months prior to screening; E8. Subjects with history of hip replacement surgery; E9. Subjects with abnormal laboratory findings at screening: Total bilirubin > 1.5 times the upper limit of the normal laboratory range(ULN); Alanine transaminase (ALT)/ aspartate transaminase (AST) >2.5 ULN; Unexplained elevation of alkaline phosphatase (ALP); Serum creatinine >ULN. E10.Subjects with positive serology for HBV, HCV, or HIV at screening; E11.Subject with any evidence of metabolic bone disease other than osteoporosis such as Pagetââ?¬•s disease; E12.Subject with any malignancy; E13.Subjects with known hypersensitivity to Teriparatide or any of its excipients; E14.Any significant medical illness that is preventing the subject from study participation; E15.Subjects who are unwilling or unable to comply with the requirements of the protocol; E16.Subject who has participated in any other clinical study in last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in bone mineral density (BMD) at lumbar spine and femoral neckTimepoint: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PD biomarkers (serum Procollagen 1 N-terminal Pro-peptide [P1NP] and bone specific alkaline phosphatase [BSAP])Timepoint: Week 12, Week 24 and Week 48 of treatment;Change in Serum calcium at randomization visitTimepoint: 4-6 hours after of Teriparatide injection;Treatment emergent serious and non-serious adverse events (AEs)Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactVinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed