Three-year longitudinal assessment of denosumab's efficacy and safety in postmenopausal osteoporosis: a 36-month real-world cohort study
Abstract
Background: Denosumab is an effective antiresorptive therapy for postmenopausal osteoporosis; however, long-term real-world data regarding sustained efficacy, treatment adherence, safety, and biochemical outcomes remain limited. This study evaluated the 36-month effectiveness and safety of denosumab in postmenopausal women with osteoporosis receiving routine clinical care.
Methods: This retrospective analysis included a prospectively followed real-world clinical cohort of 130 postmenopausal women with osteoporosis treated with denosumab (60 mg subcutaneously every 6 months) plus calcium and vitamin D supplementation. Participants were followed for 36 months with assessments at baseline, 12, 24, and 36 months. Outcomes included bone mineral density (BMD), T-scores, bone turnover markers, renal function, adherence patterns, prior treatment history, fracture occurrence, and adverse events. Changes over time were analyzed using paired longitudinal comparisons and linear mixed-effects models, with significance defined as p < 0.05.
Results: Lumbar spine (L1-L4) BMD increased from 0.674 ± 0.120 to 0.741 ± 0.102 g/cm2, while femoral neck BMD increased from 0.526 ± 0.086 to 0.562 ± 0.079 g/cm2 over 36 months (both p β-CTX and PINP, indicating sustained suppression of bone resorption. No clinically meaningful renal deterioration was observed during follow-up. Twenty-one participants had prior osteoporosis treatment history, whereas all included patients completed seven denosumab…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 130 participants or records.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.