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  ["project_title"]=>
  string(67) "Effect of SGLT2 inhibitor administration on bone health in diabetes"
  ["project_narrative_summary"]=>
  string(695) "SGLT2 inhibitors  were  recommended for treating type 2 diabetes, heart failure with or without diabetes and displayed robustly beneficial effects on metabolic dysfunction-associated steatotic liver disease, blood pressure, weight control, anemia. However, a generally unfavorable adverse effect profile accompanied with their usage especially the FDA-warned potential risk on decreased bone mineral density and increased bone fracture. The consensus had not been obtained regarding the effect of SGLT2 inhibitors on bone health in the scientific community. A clear clarification on influence and mechanism of SGLT2 inhibitors on bone homeostasis would improve safety and efficacy of drug usage."
  ["project_learn_source"]=>
  string(12) "scien_public"
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  array(7) {
    ["first_name"]=>
    string(3) "Yao"
    ["last_name"]=>
    string(3) "Sun"
    ["degree"]=>
    string(3) "PhD"
    ["primary_affiliation"]=>
    string(76) "Shanghai Tongji Stomatological Hospital and Dental School, Tongji University"
    ["email"]=>
    string(20) "yaosun@tongji.edu.cn"
    ["state_or_province"]=>
    string(8) "Shanghai"
    ["country"]=>
    string(5) "China"
  }
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      ["p_pers_f_name"]=>
      string(6) "Xuekui"
      ["p_pers_l_name"]=>
      string(4) "Wang"
      ["p_pers_degree"]=>
      string(13) "phD candidate"
      ["p_pers_pr_affil"]=>
      string(76) "Shanghai Tongji Stomatological Hospital and Dental School, Tongji University"
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      ["requires_data_access"]=>
      string(3) "yes"
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    ["value"]=>
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    ["label"]=>
    string(65) "External grants or funds are being used to support this research."
  }
  ["project_funding_source"]=>
  string(43) "National Natural Science Fundation of China"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1367) "Background

SGLT2 inhibitors were recommended for treating type 2 diabetes and heart failure[1], However, a generally unfavorable adverse effect profile accompanied with their usage especially the FDA-warned potential risk on decreased bone mineral density and increased bone fracture. The consensus had not been obtained regarding the effect of SGLT2 inhibitors on bone health in the scientific community.



Objective

The study aims to investigate whether SGLT2 inhibitors administration would impact bone health, thereby guide drug usage.



Study Design

A post hoc analysis of data from the canagliflozin clinical trials will be conducted.



Participants

This study included individuals from the clinical trial who were treated with canagliflozin and had baseline and follow-up data available for analysis.



Primary and Secondary Outcome Measures

The main outcome of interest is the change in bone remodeling markers including bone mineral density, serum collagen type-1 beta-carboxy telopeptide, serum propeptide amino terminal of type I procollagen  and bone fracture event at the endpoint. 



Statistical Analysis

The relationship between SGLT2 inhibitors using and outcomes would be mainly analyzed with Cox proportional hazards and logistic regression. "
  ["project_brief_bg"]=>
  string(2423) "Sodium–glucose cotransporter 2 (SGLT2) inhibitors were approved to treat type 2 diabetes mellitus by blocking SGLT2 function at the luminal border of the epithelial cells of the proximal convoluted tubules in the kidney, inhibiting glucose resorption and promoting glycosuria. Although initially developed as glucose-lowering agent, SGLT2 inhibitors  were also recommended for treating heart failure with or without diabetes[1] and displayed robustly beneficial effects on metabolic dysfunction-associated steatotic liver disease, blood pressure, weight control, anemia, etc[2]. 

However, a generally unfavorable adverse effect profile accompanied with their usage including ketoacidosis, hypotension, genital mycotic infections and especially the FDA-warned potential risk on decreased bone mineral density and increased bone fracture. The consensus had not been obtained regarding the effect of SGLT2 inhibitors on bone health in the scientific community, with some reporting the neutral effect of SGLT2 inhibitors on fracture risk in patients with type 2 diabetes[3,4], and some reporting the higher amputation risk [5] and bone fracture rate[6] in SGLT2 inhibitor group. We here first reviewed the relatively high-level evidences from interventional studies of mice/rat and human (see the supplementary file). It seemed like that SGLT2 inhibitors improved bone quality in diabetes background but usually disturbed bone health in control (wild-type or no diabetes) context. Notably, Slc5a2 (encoding SGLT2) knockout mice exhibited reduced cortical bone mineral density and femur length at 25-week-old, suggesting the presumable harmful impact of SGLT2 inhibition on bone remodeling. 

Thus, we had performed many mouse experiments and found that systemic administration of Empa (10mg/kg/day) on C57 mice for 6 weeks impair the bone development, while local application of Empa promote osteogenesis of bone marrow stem cells by activating mitophagy. And we had issued a clinical trial for assessing the effect of local SGLT2 inhibitor administration on bone regeneration (the drug was placed into the tooth extraction socket and the bone healing kinetics were evaluated by CBCT), related data were uploaded as supplementary file).

with the support of  data from clinical trials, we believed a clear clarification on influence and mechanism of SGLT2 inhibitors on bone homeostasis would be achieved. "
  ["project_specific_aims"]=>
  string(179) "This study aimed to investigate whether administration of SGLT2 inhibitors confer protective effect on bone remodeling by a post hoc analysis of canagliflozin clinical trial data."
  ["project_study_design"]=>
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    ["label"]=>
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  }
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(69) "confirm_or_validate previously_conducted_research_on_treatment_safety"
      ["label"]=>
      string(69) "Confirm or validate previously conducted research on treatment safety"
    }
  }
  ["project_research_methods"]=>
  string(366) "Inclusion Criteria: type 2 diabetes patients with complete data on age, sex, BMI, smoking status, HbA1c and variables of interest including bone mineral density, or serum collagen type-1 beta-carboxy telopeptide, or serum propeptide amino terminal of type I procollagen, or bone fracture events at the endpoint were included. 



Exclusion Criteria: None"
  ["project_main_outcome_measure"]=>
  string(222) "Main outcome: the change in bone mineral density at the endpoint of treatment.

Secondary outcomes include: (1) bone fracture rate across the trial period. (2)change in bone turnover markers from baseline to endpoint"
  ["project_main_predictor_indep"]=>
  string(287) "main independent variable: Cana administration

phenotypic variables: Age, Sex,  BMI, HbA1c, smoking

Disease history (categorized as Yes/No for each) osteoporosis, bone fracture,

Medication history (categorized as Yes/No ) , bisphosphonates, other bone-relevant drugs"
  ["project_other_variables_interest"]=>
  string(4) "None"
  ["project_stat_analysis_plan"]=>
  string(1047) "the clinical characteristics of the enrolled population will be presented. Normal distribution of data was assessed by the Shapiro-Wilk test, normally distributed data are presented as mean ± SD,  non-normally distributed data are shown as median with 95% CI.

Additionally, we will assess the relationship between Cana administration and bone remodeling through Cox proportional hazards models and logistic regression, this model incorporated the fixed effects of the treatment arm, trial, trial visit, treatment-by-visit interaction, and baseline value-by-visit interaction. To enhance statistical power and avoid setting arbitrary thresholds, we employed a multivariate fractional polynomial interaction approach to assess the interaction between continuous serum values and treatment assignment [7]

Sex-specific analyses were performed considering the sex differences in the distribution of bone mineral density.

All statistical tests were two-tailed, and p-values less than 0.05 were considered statistically significant."
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      ["label"]=>
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  ["project_timeline"]=>
  string(324) "Month 1 to 2: Database retrieval and data organization.

Month 2-4: Data analysis.

Month 4-6: Manuscript preparation and submitting and reporting results to the YODA project.

Month 1-6: animal experiments.

Month 6-12: Making corrections and possible amendment according to the reviewers' comments."
  ["project_dissemination_plan"]=>
  string(351) "We plan to submit a paper  entitled 'Local SGLT2 inhibitor boost osteogenesis by promoting mitophagy while systemic administration impair osteogenesis'. We aim to submit it to Science Translational Medicine or Journal of Clinical Investigations, Also, we will consider submit the abstract to the IADR, FDI and present our results in these conferences."
  ["project_bibliography"]=>
  string(1520) "

Heidenreich, P.A., et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2022, 145, e895-e1032.
O’Hara, D.V., et al. Applications of SGLT2 inhibitors beyond glycaemic control. Nat Rev Nephrol, 2024, 20, 513-529.
Zhuo, M., et al. Association of Sodium-Glucose Cotransporter–2 Inhibitors With Fracture Risk in Older Adults With Type 2 Diabetes. JAMA Network Open, 2021, 4, e2130762-e2130762.
Ko, H.Y., et al. Sodium-Glucose Cotransporter 2 Inhibitors vs Incretin-Based Drugs and Risk of Fractures for Type 2 Diabetes. JAMA Network Open, 2023, 6, e2335797-e2335797.
Impact of diabetes on the effects of sodium glucose co-transporter-2 inhibitors on kidney outcomes: collaborative meta-analysis of large placebo-controlled trials. Lancet, 2022, 400, 1788-1801.
Neal, B., et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med, 2017, 377, 644-657.
Royston, P. & Sauerbrei, W. Two Techniques for Investigating Interactions between Treatment and Continuous Covariates in Clinical Trials. The Stata Journal, 2009, 9, 230-251.

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