Objective:

To evaluate the 36-month effectiveness and safety of denosumab in postmenopausal women with osteoporosis receiving routine clinical care.

Approach:

• Study Design: Retrospective analysis of a prospectively followed cohort of 130 postmenopausal women treated with denosumab.
• Treatment Protocol: Participants received denosumab (60 mg subcutaneously every 6 months) along with calcium and vitamin D supplementation.
• Outcome Measures: Assessments included bone mineral density (BMD), T-scores, bone turnover markers, renal function, adherence patterns, fracture occurrence, and adverse events.
• Statistical Analysis: Changes over time were analyzed using paired longitudinal comparisons and linear mixed-effects models.

Key Findings:

• Lumbar spine BMD increased from 0.674 to 0.741 g/cm2 and femoral neck BMD from 0.526 to 0.562 g/cm2 over 36 months (both p < 0.001).
• Bone turnover markers showed sustained suppression of bone resorption.
• No clinically meaningful renal deterioration was observed.
• All patients completed seven denosumab injections, with most delays in injections being <30 days.
• No new fragility fractures or serious adverse events were reported.

Interpretation:

Thirty-six months of denosumab treatment was associated with sustained improvement in BMD and suppression of bone turnover, with acceptable adherence and a favorable safety profile.

Limitations:

• Only patients completing all seven injections were included, which may overestimate adherence and safety outcomes.
• The study was conducted in a single center, which may limit generalizability of the findings.

Conclusion:

The findings indicate the effectiveness of denosumab under routine clinical practice, highlighting the need for continued monitoring and adherence management.