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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab 60 MG/ML | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bone Fracture | number of newly developed vertebral and femur fractures during follow-up | 12 month |
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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
Exclusion Criteria:
Because denosumab treatment only has FDA approval for postmenopausal osteoporosis.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niğde Bor FTR Education and Training hospital | Niğde | 51000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 13. Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwiński E, Bone HG, et al. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020;31(1):181-91. 14. Kamimura M, Nakamura Y, Ikegami S, Uchiyama S, Kato H, Taguchi A. Significant improvement of bone mineral density and bone turnover markers by denosumab therapy in bisphosphonate-unresponsive patients. Osteoporos Int. 2017;28(2):559-66. 15. Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014;58:48-54 16. von Keyserlingk C, Hopkins R, Anastasilakis A, Toulis K, Goeree R, Tarride JE, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum. 2011;41(2):178-86. |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |