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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/05/052831

Enrollment

200

Registered

2023-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Denosumab 60 mg Injection: Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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 3. Women giving written, voluntary informed consent for study participation.

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Number of AEs (adverse events) and Number of adverse reactions (ARs)Timepoint: Baseline, week 12, week 24 and week 26	—

Secondary

Measure	Time frame
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.Timepoint: 24 week	—

Countries

India

Contacts

Public ContactDr Dattatray Pawar

Alkem Laboratories Limited

akhilesh.sharma@alkem.com022-39829999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026