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

Phase 4

Active, not recruiting

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

• Registration Number: CTRI/2023/05/052831
• Lead Sponsor: Enzene Biosciences Limited

Brief Summary

A phase IV, open label, single-arm, multi-centre clinical study to evaluate the safety and efficacy of denosumab in patients with postmenopausal osteoporosis.

A total 200 subject who meet eligibility criteria will be given Denosumab (Enzene Biosciences Ltd) 60 mg 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) 60 mg 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 safety of denosumab in patients with postmenopausal osteoporosis.



Secondary Objectives:

To evaluate efficacy of denosumab 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 post menopause, aged > 50 to 80 years.
• Have low bone mass density test (dual energy X-ray absorptiometry) Bone mineral Density Tscore < -2.5 standard deviation at any one of two sites measured ( Lumbar spine [L1-L4] and Femoral neck) 3.
• Women giving written, voluntary informed consent for study participation.

Exclusion Criteria

• Known hypersensitivity to denosumab or any of its excipients 2.
• Pre-existing hypocalcemia 3.
• Subject previously treated with Denosumab 4.
• Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening 5.
• Subjects with hyperparathyroidism or hypoparathyroidism at screening 6.
• Subjects with thyroid dysfunction 7.
• Metabolic bone diseases other than postmenopausal osteoporosis including hyperthyroidism, Cushing diseases and Pagets diseases.
• Any of the following oral/dental conditions: a.
• prior history or current evidence of osteomyelitis or osteonecrosis of jaw b.
• Active dental or jaw condition which requires oral surgery c.
• Non-healed dental or oral surgery 9.
• Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study 10.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of AEs (adverse events) and Number of adverse reactions (ARs)	Baseline, week 12, week 24 and week 26

Secondary Outcome Measures

Name	Time	Method
1. Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.	2. Percentage change from baseline to Week 24 in bone mineral density (BMD) at lumbar spine and femoral neck.

Trial Locations

Locations (6)

Hira Mongi Navneet Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

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

Lifepoint Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Medipoint Hospital; 🇮🇳 Pune, MAHARASHTRA, India

St. Georges Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Hira Mongi Navneet Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Karthik Subramanian

Principal investigator

9082780282

drkarthik.hmn@gmail.com