A clinical trial to study effects of Teriparatide in the Treatment of Postmenopausal Osteoporosis.

Phase 4

Active, not recruiting

• Conditions: Age-related osteoporosis without current pathological fracture,

• Registration Number: CTRI/2023/05/052618
• Lead Sponsor: Enzene Biosciences Limited

Brief Summary

This is a phase IV, prospective, open label, single-arm, multicentre clinical study to evaluate the safety and efficacy of teriparatide in patients with postmenopausal osteoporosis.

A total 200 subject who meet eligibility criteria will be given teriparatide (Enzene Biosciences Ltd) 20 mcg subcutaneously once only.



The study duration will be approximately 53 weeks considering 24 weeks of recruitment period and 29 weeks of study period.



The study comprises of 3 periods:



Screening Period: It will last up to 3 weeks

Treatment Period: It will last for 24 weeks; all subjects will receive Denosumab (Enzene Biosciences Ltd) 20 mcg subcutaneously once only;

Follow-up Period: It will last for 2 weeks after completion of Treatment Period.



Primary Objectives:

The primary objective of this study is to evaluate the safety of teriparatide injection in patients with postmenopausal osteoporosis.



Secondary Objectives:

To evaluate the efficacy of teriparatide injection in patients with postmenopausal osteoporosis.

To assess the pharmacodynamics (PD) response of teriparatide injection in patients with postmenopausal osteoporosis

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-13
• Last Update Posted: 2024-02-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women with at least 5 years of post menopause, aged > 50 to 80 years 2.
• Postmenopausal women with osteoporosis.

Exclusion Criteria

• 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.
• unexplained elevation of alkaline phosphatase 6.
• Prior external beam or implant radiation therapy to the skeleton.
• patients with skeletal malignancies or bone metastases should be excluded from the treatment with teriparatide.
• 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
Number of AEs and number of adverse reactions	26 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

HBT Trauma Care Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Imperial Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Ishwar Institute of Health Care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Lifepoint Multispecialty hospital; 🇮🇳 Pune, MAHARASHTRA, India

Medipoint Hospitals Pvt. Ltd.; 🇮🇳 Pune, MAHARASHTRA, India

Sanjeevani criticare and Research centre; 🇮🇳 Nashik, MAHARASHTRA, India

HBT Trauma Care Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Amit Joshi

Principal investigator

7702977885

dr.amitjoshi85@gmail.com