Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Denosumab 60 MG/ML


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Bone Fracture | number of newly developed vertebral and femur fractures during follow-up | 12 month |