Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Completed

• Conditions: Postmenopausal Osteoporosis

• Registration Number: NCT04702204
• Lead Sponsor: Nigde Omer Halisdemir University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Status Verified: 2021-08
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-15
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

• Being a woman with postmenopausal osteoporosis

• Being between the ages of 45-85

• Using bisphosphonate therapy for at least two years

• Vertebral and/or Femur T score below -2.5

• Unresponsive to bisphosphonate therapy

  • More than 2% decrease in BMD values despite using bisphosphonates and/or
  • New major fracture development during treatment

Exclusion Criteria

• Male gender
• Being extremely thin (BMI <15) or extremely obese (BMI> 45)
• Malignancy
• Severe chronic liver and kidney failure
• Chronic Steroid use
• Having an active rheumatic disease
• Having other secondary causes of osteoporosis (primary hyperparathyroidism etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density	12 month	Femur and spine bone mineral density measurements of the patients at the baseline and the 12th month were performed using the Dual Energy X-ray Absorptiometry (DEXA) machine (Stratos dR 2D Fan-Beam, DMS company, France).

Secondary Outcome Measures

Name	Time	Method
Major Bone Fracture	12 month	number of newly developed vertebral and femur fractures during follow-up

Trial Locations

Locations (1)

Niğde Bor FTR Education and Training hospital; 🇹🇷 Niğde, Turkey