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Clinical Trial
. 2022 Mar 5:14:995-1005.
doi: 10.2147/CMAR.S354471. eCollection 2022.

99Tc-Methylene Diphosphonate Treatment is Safe and Efficacious for Osteoporosis in Postmenopausal Differentiated Thyroid Cancer Patients Undergoing TSH Suppression: A Three-Center Non-Randomized Clinical Study

Jianhao Xie #  1   2 , XueYu Yuan #  1 , Weiqing Mao #  1 , Haidong Cai  1 , Kejia Gao  3 , Zhongwei Lv  1 , Hui Wang  4 , Chao Ma  1
Affiliations
Clinical Trial

99Tc-Methylene Diphosphonate Treatment is Safe and Efficacious for Osteoporosis in Postmenopausal Differentiated Thyroid Cancer Patients Undergoing TSH Suppression: A Three-Center Non-Randomized Clinical Study

Jianhao Xie et al. Cancer Manag Res. .

Abstract

Objective: To investigate the effects of 99Tc-methylene diphosphonate (99Tc-MDP) on osteoporosis (OS) in postmenopausal patients with differentiated thyroid cancer (DTC) under thyroid stimulating hormone (TSH) suppression.

Patients and methods: Patients (n = 142) were divided into two groups: (1) 99Tc-MDP (n = 70) and (2) alendronate (n = 72) treatments (NCT02304757). Bone mineral density (BMD) in the lumbar spine and hip was evaluated by DXA, along with bone turnover markers, safety, and quality of life (QOL) using SF-36 at three time points: before treatment and at 6 and/or 12 months after treatment.

Results: The percentage change of BMD in total lumbar spine or hip showed no significant difference throughout the study (P > 0.025). 99Tc-MDP and alendronate treatment alone significantly increased BMD in the lumbar spine, but alendronate treatment also significantly increased BMD in total hip at 6 and 12 months, as compared with the baseline. There were no significant differences in the results of the SF-36 scores between the two treatment groups at any time during the whole study period. 99Tc-MDP significantly increased bone formation markers of osteocalcin at 6 and 12 months (P all < 0.05), PINP at 12 months (P = 0.001), and bone resorption markers of β-CTX at 6 and 12 months (p < 0.05) as compared with the alendronate treated group. No adverse event was observed in the 99Tc-MDP treatment group compared with alendronate (P = 0.014).

Conclusion: 99Tc-MDP was as efficacious as alendronate in the improvement of lumbar BMD for DTC patients with OS under TSH stimulation. 99Tc-MDP was shown to be safe and improved patients' QOL.

Keywords: 99Tc-MDP; differentiated thyroid cancer; osteoporosis; thyroid stimulating hormone suppression.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Percentage change from baseline in bone mineral density (BMD). No significance was found in the two treatment groups during the study. Vertical lines represent the 95% confidence intervals at each time point. A dagger indicates P < 0.025 for the within-group comparisons with the baseline at 6 and 12 months in the lumbar spine in 99Tc-MDP (P = 0.019 and 0.0005, respectively) and alendronate (P = 0.017 and < 0.001, respectively) treated groups. Alendronate treatment also significantly increased BMD in the total hip at 6 and 12 months (P = 0.0075 and 0.0155, respectively).
Figure 3
Figure 3
Percentage change from baseline in levels of bone-turnover markers. The mean percentage change from baseline in the levels of serum β-isomer of C-terminal telopeptide of type I collagen (β-CTX), procollagen type 1 N-terminal propeptide (P1NP), osteocalcin, and bone alkaline phosphatase (ALP) are shown at 6 and 12 months after the baseline visit. An asterisk indicates P < 0.05 for the comparisons between 99Tc-MDP and alendronate treated groups. 99Tc-MDP significantly increased bone formation markers of osteocalcin (P < 0.001) and PINP at 12 months (P = 0.0005) as compared with the alendronate treated group. A significant decrease was found in bone resorption β-CTX at 6 months (P = 0.0005) and 12 months (P < 0.001), and a significant decrease of ALP at 6 months (P = 0.0045) in the alendronate treated group as compared with the 99Tc-MDP treatment group. The vertical lines represent the 95% confidence intervals at each time point. A dagger indicates P < 0.05 for the within-group comparisons with baseline.
Figure 4
Figure 4
The results of the combined mental component score in a 36-item Short Form Health Status Survey questionnaire (SF-36) for the 99Tc-MDP group and the alendronate group (Mann-Whitney U-test). No significant difference was found in the two treatment groups during the study. A dagger indicates P < 0.05 for the comparisons of physical component summary (PCS) and mental component score (MCS) with the baseline at 6 months (P = 0.008 and 0.0055, respectively) and 12 months (P = 0.001 and 0.013, respectively) in 99Tc-MDP treated group.
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