NCT04702204

Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Nigde Omer Halisdemir University · Academic / Other
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study. At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab 60 MG/ML	Denosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts. Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-08-15
• Completion: 2021-08-15
• First posted: 2021-01-08
• Last updated: 2021-09-01

Locations

1 site across 1 country: Turkey (Türkiye)