Comparative bone histomorphometry effects of combined denosumab and teriparatide vs monotherapy in postmenopausal women with osteoporosis: a randomized controlled trial
Abstract
Combined treatment with PTH receptor stimulation (teriparatide 20-μg) and RANKL inhibition (denosumab 60-mg) increases spine and hip BMD and improves estimates of bone strength to a greater extent than either monotherapy. The mechanisms underlying the enhanced efficacy of this combination, however, are not fully defined. In this randomized, 3-arm interventional trial, postmenopausal women with osteoporosis were randomized to receive denosumab 60-mg (n = 9), teriparatide 20-μg (n = 13), or both (n = 12) for 3 mo. Participants received double fluorochrome labeling and underwent a single iliac crest bone biopsy at month 3. A total of 26 bone biopsies were suitable for histomorphometry. Fluorescence microscopy was utilized to differentiate remodeling-based from modeling-based bone formation in the cancellous and endocortical envelopes by identifying the morphology of underlying cement lines as either scalloped or smooth, respectively. Within-subject 3-mo changes from baseline were compared among the 3 treatment groups using one-way ANOVA. At 3 mo, teriparatide significantly increased histomorphometric indices of bone formation (BFR/BS, MS/BS, and dLS/BS) compared to denosumab or combination therapy, consistent with its greater effect on bone formation markers. Although both remodeling- and modeling-based bone formation increased in the combination group, denosumab attenuated the teriparatide-induced increases bone in formation, except for modeling-based bone formation in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, 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: 13 participants or records.
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