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. 2023 May 26;108(11):e1424–e1432. doi: 10.1210/clinem/dgad289

Table 1.

Eligibility criteria for clinical studies used in the systematic literature review

Eligibility criteria Included Excluded
Population
  • Adults (18+ years) with ND-CKD, with or without SHPT

  • Pediatric patients

  • Patients on dialysis

  • Patients who have undergone parathyroidectomy

Interventions/comparators
  • Any pharmacological intervention or combination of interventions commonly used for the treatment of SHPT or adjustment of SHPT-relevant biomarkers, specifically:

    • nutritional vitamin D (NVD) supplementation

      • cholecalciferol

      • ergocalciferol

    • calcitriol (the active form of vitamin D)

    • vitamin D receptor activators (VDRA)/active vitamin D analogues

      • alfacalcidol

      • paricalcitol

      • doxercalciferol

    • calcifediol

      • extended-release (PR) calcifediol

      • immediate-release (IR) calcifediol (referred to as calcifediol in this report)

    • calcimimetic

      • cinacalcet

  • Non-pharmacological therapies eg, surgery, dietary

Outcomes
  • Treatment-specific efficacy/effectiveness

    • Changes in biomarker levels from baseline; PTH, vitamin D metabolites (25(OH)D and 1,25(OH)2D), Calcium, Phosphate, FGF23

  • Treatment-specific outcomes

    • Hypercalcemia, hyperphosphatemia, CV event, fracture, mortality, CKD progression, hospitalization, anemia, reduced BMD, parathyroidectomy

Study design
  • Comparative RCT

Comparative CCT, comparative observational studies, case studies, case reports, economic evaluations, reviews, meta-analyses
Other eligibility criteria
  • Studies of patients with ≥20 patients

  • English language only

  • Publication year: any year (until date of search: May 31, 2022)

Abbreviations: 1,25(OH)2D, 1,25-dihydroxyvitamin D; 25(OH)D, 25-hydroxyvitamin D; BMD, bone mineral density; CKD, chronic kidney disease; FGF23, fibroblast growth factor 23; ND-CKD, non-dialysis chronic kidney disease; PTH, parathyroid hormone; RCT, randomized controlled trial; SHPT, secondary hyperparathyroidism.