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

Phase 4

Conditions: Health Condition 1: M810- Age-related osteoporosis without current pathological fracture

Registration Number: CTRI/2023/05/052831

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 post menopause, aged > 50 to 80 years.

2. 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

1. 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.

8. 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. Planned invasive dental procedure

d. 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
umber of AEs (adverse events) and Number of adverse reactions (ARs)Timepoint: 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. <br/ ><br>2. Percentage change from baseline to Week 24 in bone mineral density (BMD) at lumbar spine and femoral neck.Timepoint: 24 week