Effects of Two Years of Teriparatide, Denosumab, or Both on Bone Microarchitecture and Strength (DATA-HRpQCT study)

Abstract

Context: In postmenopausal osteoporosis, combining denosumab and teriparatide increases hip and spine bone mineral density more than either monotherapy.

Objective: The objective of the study was to determine the effects of 2 years of combination therapy on bone microarchitecture and estimated strength.

Design: This was an open-label, randomized controlled trial.

Participants and methods: We performed high-resolution peripheral quantitative computed tomography at the distal tibia and radius in 94 postmenopausal osteoporotic women randomized to 2 years of teriparatide 20 μg sc daily, denosumab 60 mg sc every 6 months, or both.

Results: Total volumetric bone mineral density (vBMD) at the radius and tibia, trabecular vBMD at the radius, and cortical vBMD at the tibia all increased more in the combination group than both monotherapy groups (P < .002 for all comparisons with combination). Cortical thickness at the tibia also increased more in the combination group (8.1% ± 4.3%) than both other groups (P < .001). Cortical porosity at both the radius and tibia increased progressively over the 24-month treatment period in the teriparatide group but was stable in both other groups (P < .001 teriparatide vs both other groups). Trabecular vBMD at the tibia increased similarly in all groups, whereas radius trabecular vBMD increased more in the combination group than the other groups (P < .01 for both comparisons). Finite element analysis-estimated strength improved or was maintained by all treatments at both the radius and tibia.

Conclusions: Two years of combined teriparatide and denosumab improves bone microarchitecture and estimated strength more than the individual treatments, particularly in cortical bone. These findings suggest that this regimen may be beneficial in postmenopausal osteoporosis.

Trial registration: ClinicalTrials.gov NCT00926380.

Figures

Figure 1.

Subject disposition.

Figure 2.

Mean percentage change (SEM) from baseline at the distal tibia and radius in vBMD and TMD over 24 months. *, P < .05 vs baseline; **, P < .05 vs 12 months for 12- to 24-month change; a, P < .05 vs TPTD alone; b, P < .05 vs DMAB alone.

Figure 3.

Mean percentage change (SEM) from baseline at distal tibia and radius in cortical thickness and cortical porosity over 24 months. *, P < .05 vs baseline; **, P < .05 vs 12-months for 12- to 24-month change; a, P < .05 vs TPTD alone; b, P < .05 vs DMAB alone.

Figure 4.

Mean percentage change (SEM) from baseline at distal tibia and radius in stiffness and failure load at 24 months. *, P < .05 vs baseline. Brackets denote a value of P < .05 between group comparisons.