Efficacy of Zoledronic Acid in Maintaining Areal and Volumetric Bone Density After Combined Denosumab and Teriparatide Administration: DATA-HD Study Extension

Ramchand, Sabashini K; David, Natalie L.; Lee, Hang; Eastell, Richard; Tsai, Jui‐Hsiu; Leder, Benjamin Z.

doi:10.1002/jbmr.4259

Cited by 25 publications

(18 citation statements)

References 31 publications

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“…Similar changes were found in the DATA-HD Extension Trial by Ramchand and colleagues, where bone microarchitecture was evaluated 12 and 27 months after ZOL. (19,20) Aging is associated with a thinning of the cortex, leaving cortical remnants that resembles trabecular bone, and Zebaze and colleagues found that when including these as trabecular bone, trabecular density is overestimated. (28) Furthermore, there was a threefold underestimation of the increase in cortical porosity, when the compact cortical bone was evaluated without the trabecularized cortex.…”

Section: Discussionmentioning

confidence: 99%

“…In the DATA-HD Extension Trial, postmenopausal women (n = 53) were treated with a combination of teriparatide and DMAB for 9 months followed by 6 months of DMAB therapy before receiving a single infusion of ZOL 5.5 to 8 months after the last DMAB. (19,20) Twelve months after ZOL, BMD was maintained at all sites; however, 27 months after ZOL, LS BMD had decreased (−3.7%) and BTMs increased toward baseline levels. The AfterDmab, a randomized clinical trial, allocated 57 postmenopausal women treated with DMAB for 2.0 to 2.4 years to either two injections of DMAB or a single infusion of ZOL.…”

Section: Discussionmentioning

confidence: 99%

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Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study

Sølling

Harsløf

Langdahl

2020

Journal of Bone and Mineral Research

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Increased bone turnover and rapid bone loss follow discontinuation of denosumab. We investigated the long-term efficacy of zoledronate (ZOL) in maintaining bone mineral density (BMD) after discontinuation of denosumab. In this randomized, open-label, interventional study, we included 61 postmenopausal women and men older than 50 years discontinuing denosumab after 4.6 AE 1.6 years. We administered ZOL 6 months (6 M) or 9 months (9 M) after the last denosumab or when bone turnover had increased (observation group [OBS]). ZOL was readministrated if p-cross-linked C-terminal telopeptide (p-CTX) increased ≥1.26 μg/L or BMD decreased ≥5%. The results after 12 months have previously been published; here we report the outcome after 24 months (ClinicalTrials NCT03087851). Fifty-eight patients completed the study. From 12 to 24 months after the initial ZOL, lumbar spine (LS) BMD was maintained: 0.9 AE 0.9%, 0.4 AE 0.8%, and 0.3 AE 0.7% in the 6 M, 9 M, and OBS groups, respectively (p > .05, no between-group differences). Similarly, total hip (TH) and femoral neck (FN) BMD did not change in any group during year 2. From baseline to 24 months after ZOL, LS BMD decreased by 4.0 AE 0.8%, 4.1 AE 0.8%, and 4.3 AE 1.5% in the 6 M, 9 M, and OBS groups, respectively (p < .001, no between-group differences). Significant bone loss (LS, TH, or FN) was found in all groups 24 months after ZOL: 6 M group: n = 12 (60%), 9 M group: n = 7 (37%), and OBS group: n = 10 (53%). P-CTX did not change significantly during the second year (p > .05, no between-group differences). No patient fulfilled the CTX or fracture criteria for retreatment during year 2; however, 9 patients were retreated at M24 due to BMD loss ≥5%. Two patients sustained a non-vertebral fracture during year 2. Treatment with ZOL subsequent to long-term denosumab did not fully prevent increased bone turnover and bone loss during the first year; however, CTX remained with the reference range and BMD was maintained during the second year.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study

Sølling

Harsløf

Langdahl

2020

Journal of Bone and Mineral Research

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“…Meanwhile, HORIZON study [21] had indicated that compared to risedronate, ZOL could more significantly improve BMD at lumbar spine (4.06% vs 2.71%), total hip (1.65% vs 0.45%), and femoral neck (1.45% vs 0.39%). Moreover, ZOL had a longer half-life time in bone, which could continuously reduce bone loss [22][23][24][25]. Treatment with annual infusion of ZOL was convenient and conducive to improve the compliance and persistence of osteoporosis patients and could still play a role for a long time after discontinuation [26].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study

Cheng

Huo

et al. 2022

Arch Osteoporos

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Summary Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population. Introduction Yigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL. Methods This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups. Results A total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: − 0.71 to 1.00, equivalence margin: − 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and β-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (β-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups. Conclusion Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.

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“…Our results show that participants reporting vigorous physical activity had on average 28.2 mg/cm 2 higher aBMD in the left total hip compared with inactive participants, after adjusting for multiple confounders, which corresponds to roughly 3% of the sample mean. To put this into context, a recent randomized clinical trial showed a 5.1% increase in total hip BMD after 15 months of pharmaceutical treatment [ 34 ]. However, encouraging inactive individuals to become vigorously physically active is challenging, and physical activity is likely not the sole solution to improving or maintaining BMD in the population.…”

Section: Discussionmentioning

confidence: 99%

A 15-year follow-up study of hip bone mineral density and associations with leisure time physical activity. The Tromsø Study 2001–2016

et al. 2022

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Aims The aim was to investigate the long-term association between leisure time physical activity and hip areal bone mineral density (aBMD), in addition to change in hip aBMD over time, in 32–86 years old women and men. Methods Data were retrieved from the 2001, 2007–2008, and 2015–2016 surveys of the Tromsø Study, a longitudinal population study in Norway. Leisure time physical activity was assessed by the four-level Saltin-Grimby Physical Activity Level Scale which refers to physical exertion in the past twelve months. Hip aBMD was assessed by Dual-Energy X-ray Absorptiometry. Linear Mixed Model analysis was used to examine long-term associations between physical activity and hip aBMD (n = 6324). In addition, the annual change in hip aBMD was analyzed in a subsample of 3199 participants. Results Physical activity was significantly and positively associated with total hip aBMD in the overall cohort (p<0.005). Participants who reported vigorous activity had 28.20 mg/cm2 higher aBMD than those who were inactive (95% CI 14.71; 41.69, controlled for confounders), and even light physical activity was associated with higher aBMD than inactivity (8.32 mg/cm2, 95% CI 4.89; 11.76). Associations between physical activity and femoral neck aBMD yielded similar results. Hip aBMD decreased with age in both sexes, although more prominently in women. From 2001 to 2007–2008, aBMD changed by –5.76 mg/cm2 per year (95% CI –6.08; –5.44) in women, and –2.31 mg/cm2 (95% CI –2.69; –1.93), in men. From 2007–2008 to 2015–2016, the change was –4.45 mg/cm2 per year (95% CI –4.84; –4.06) in women, and –1.45 mg/cm2 (95% CI –1.92; –0.98) in men. Conclusions In this cohort of adult men and women, physical activity levels were positively associated with hip aBMD in a dose-response relationship. Hip aBMD decreased with age, although more pronounced in women than men.

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Efficacy of Zoledronic Acid in Maintaining Areal and Volumetric Bone Density After Combined Denosumab and Teriparatide Administration: DATA-HD Study Extension

Cited by 25 publications

References 31 publications

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis: A 2-Year Randomized Study

Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study

A 15-year follow-up study of hip bone mineral density and associations with leisure time physical activity. The Tromsø Study 2001–2016

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