Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Nigde Omer Halisdemir University73 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

Denosumab 60 MG/MLDRUG

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.

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.).

Outcomes

Primary Outcomes

Bone mineral density

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).

Time frame: 12 month

Secondary Outcomes

Major Bone Fracture

number of newly developed vertebral and femur fractures during follow-up