Bone Mineral Density After Transitioning From Denosumab to Alendronate
Abstract
CONTEXT: There are few studies on patients transitioning from denosumab to bisphosphonates.
OBJECTIVE: To investigate patient characteristics and changes in bone mineral density (BMD) after transitioning from denosumab to alendronate.
DESIGN: Randomized, open-label, 2-year crossover Denosumab Adherence Preference Satisfaction (DAPS) study (NCT00518531).
SETTING: 25 study centers in the US and Canada.
PATIENTS: Treatment-naïve postmenopausal women with BMD T-scores from -2.0 to -4.0.
INTERVENTIONS: This post hoc analysis evaluated women randomized to subcutaneous denosumab 60 mg every 6 months in year 1 followed by once-weekly oral alendronate 70 mg in year 2.
MAIN OUTCOME MEASURE: A 3% BMD threshold identified participants who lost, maintained, or gained BMD in year 2 on alendronate.
RESULTS: Of 126 participants randomized to denosumab, 115 (91%) transitioned to alendronate in year 2. BMD increased by 3% to 6% with denosumab in year 1 and by 0% to 1% with alendronate in year 2. After transitioning to alendronate, most participants maintained or increased BMD; 15.9%, 7.6%, and 21.7% lost BMD at the lumbar spine, total hip, and femoral neck, respectively. Few participants fell below their pretreatment baseline BMD value; this occurred most often in those who lost BMD in year 2. Women who lost BMD with alendronate in year 2 also showed a greater percent change in BMD with denosumab in year 1. The BMD change in year 2 was similar regardless of baseline characteristics or…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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