A clinical trial to study effects of Teriparatide in the Treatment of Postmenopausal Osteoporosis.
Phase 4
- Conditions
- Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
- Registration Number
- CTRI/2023/05/052618
- Lead Sponsor
- Enzene Biosciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Women with at least 5 years of post menopause, aged > 50 to 80 years
2. Postmenopausal women with osteoporosis
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method