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Relationship between bone turnover and density with teriparatide, denosumab or both in women in the DATA study.

ABSTRACT: BACKGROUND:While changes in biochemical markers of bone turnover (BTM) have been reported to predict changes in bone mineral density (BMD), the relationship between changes in BMD and BTMs with combined antiresorptive/anabolic therapy is unknown. METHODS:In the DATA study, 94 postmenopausal osteoporotic women (ages 51-91) received either teriparatide 20-mcg SC daily, denosumab 60-mg SC every 6months, or both for 2years. Pearson's correlation coefficients (R) were calculated to determine the relationship between baseline and early changes in BTMs (as well as serum sclerostin) and 2-year changes in BMD. RESULTS:In women receiving teriparatide, baseline BTMs did not correlate with 2-year BMD changes though 12-month increases in osteocalcin and P1NP were associated with 2-year increases in spine BMD. In women receiving denosumab, spine and hip BMD gains correlated with both baseline and changes in P1NP and C-telopeptide. In women receiving combined teriparatide/denosumab, while both baseline and decreases in P1NP were associated with spine BMD gains, distal radius increases were associated with less CTX suppression. Neither baseline nor changes in serum sclerostin correlated with BMD in any treatment group. SUMMARY AND CONCLUSIONS:In women treated with teriparatide or denosumab, early BTM changes (increases and decreases, respectively) predict 2-year BMD gains, especially at the spine. In women treated with combined teriparatide/denosumab therapy, BMD increases at the distal radius were associated with less suppression of bone turnover. These results suggest that efficacy of combination therapy at cortical sites such as the radius may depend on residual bone remodeling despite RANKL inhibition.

SUBMITTER: Tsai JN

PROVIDER: S-EPMC6941193 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Relationship between bone turnover and density with teriparatide, denosumab or both in women in the DATA study.

Tsai J N JN Burnett-Bowie S M SM Lee H H Leder B Z BZ

Bone 20161111

<h4>Background</h4>While changes in biochemical markers of bone turnover (BTM) have been reported to predict changes in bone mineral density (BMD), the relationship between changes in BMD and BTMs with combined antiresorptive/anabolic therapy is unknown.<h4>Methods</h4>In the DATA study, 94 postmenopausal osteoporotic women (ages 51-91) received either teriparatide 20-mcg SC daily, denosumab 60-mg SC every 6months, or both for 2years. Pearson's correlation coefficients (R) were calculated to det ...[more]

PMID: 27840301

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Project description:Combined teriparatide and denosumab increases spine and hip bone mineral density more than either drug alone. The effect of this combination on skeletal microstructure and microarchitecture, however, is unknown. Because skeletal microstructure and microarchitecture are important components of skeletal integrity, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) assessments at the distal tibia and radius in postmenopausal osteoporotic women randomized to receive teriparatide 20?µg daily (n?=?31), denosumab 60?mg every 6 months (n?=?33), or both (n?=?30) for 12 months. In the teriparatide group, total volumetric bone mineral density (vBMD) did not change at either anatomic site but increased in both other groups at both sites. The increase in vBMD at the tibia was greater in the combination group (3.1?±?2.2%) than both the denosumab (2.2?±?1.9%) and teriparatide groups (-0.3?±?1.9%) (p?<?0.02 for both comparisons). Cortical vBMD decreased by 1.6?±?1.9% at the tibia and by 0.9?±?2.8% at the radius in the teriparatide group, whereas it increased in both other groups at both sites. Tibia cortical vBMD increased more in the combination group (1.5?±?1.5%) than both monotherapy groups (p?<?0.04 for both comparisons). Cortical thickness did not change in the teriparatide group but increased in both other groups. The increase in cortical thickness at the tibia was greater in the combination group (5.4?±?3.9%) than both monotherapy groups (p?<?0.01 for both comparisons). In the teriparatide group, radial cortical porosity increased by 20.9?±?37.6% and by 5.6?±?9.9% at the tibia but did not change in the other two groups. Bone stiffness and failure load, as estimated by finite element analysis, did not change in the teriparatide group but increased in the other two groups at both sites. Together, these findings suggest that the use of denosumab and teriparatide in combination improves HR-pQCT measures of bone quality more than either drug alone and may be of significant clinical benefit in the treatment of postmenopausal osteoporosis.

Project description:In postmenopausal women, 2?yr of combined teriparatide and denosumab increases bone mineral density more than either drug alone, and switching from either combination or teriparatide to denosumab for an additional 2?yr further increases bone mineral density. Conversely, switching from denosumab to teriparatide results in transient bone loss. The effects of these interventions on spine microarchitecture are unknown. In the DATA and DATA-Switch studies, 94 postmenopausal osteoporotic women were randomized to receive 24?mo of teriparatide (20?µg daily), denosumab (60?mg every 6?mo), or both. Then, women originally assigned to 24?mo of teriparatide received 24?mo of denosumab, whereas subjects originally randomized to 24?mo of denosumab received 24?mo of teriparatide. Subjects who received both drugs received an additional 24?mo of denosumab alone. Spine trabecular bone score (TBS, a gray-level textural assessment of bone microarchitecture) was measured blinded from treatment groups using images from 2-dimensional dual-energy X-ray absorptiometry spine scans at 0, 12, 24, 30, 36, and 48?mo in 65 women who had posterior-anterior spine dual-energy X-ray absorptiometry images suitable for TBS analysis. After 24?mo, TBS increased by 2.7?±?4.7% in the teriparatide group (p?=?0.009 vs baseline), by 1.8?±?5.0% in the denosumab group (p?=?0.118 vs baseline), and by 4.5?±?6.7% in the combination group (p?=?0.017 vs baseline), with no significant between-group differences. In the 6?mo after the treatments were switched (months 24-30), TBS continued to increase in the combination-to-denosumab and teriparatide-to-denosumab groups but decreased by -1.1?±?4.0% in the denosumab-to-teriparatide group (p?<?0.05 vs other groups). After 48?mo, compared to month 0, TBS increased by 5.1?±?5.8% in the teriparatide-to-denosumab group, by 3.6?±?4.2% in the denosumab-to-teriparatide group, and by 6.1?±?4.7% in the combination-to-denosumab group (p?<?0.001 vs baseline for all groups, p?=?not significant for between-group differences). Switching from teriparatide to denosumab also increased spine TBS. Conversely, switching from denosumab to teriparatide transiently degraded spine trabecular microarchitecture, the clinical consequences of which require further study.

Dataset Information

Relationship between bone turnover and density with teriparatide, denosumab or both in women in the DATA study.

Publications

Relationship between bone turnover and density with teriparatide, denosumab or both in women in the DATA study.

Similar Datasets

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