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. 2014 Dec 9;2014(12):CD006254. doi: 10.1002/14651858.CD006254.pub2

Harris 2004.

Methods
  • Study design: parallel RCT

  • Study duration: NS

  • Study follow‐up: 12 weeks

Participants
  • Country: USA

  • Setting: multicentre (2 centres)

  • Medically stable patients with serum calcium levels corrected for albumin concentration ≥ 8.4 mg/dL; serum phosphorous levels ≥ 3.0 mg/dL

  • Number: treatment group (17); control group (5)

  • Mean age ± SD (years): treatment group (48.5 ± 10.4); control group (48 ± 13.1)

  • Sex (M/F): treatment group (14/3); control group (4/1)

  • Exclusion criteria: NS

Interventions Treatment group
  • Cinacalcet: 25 to 300 mg/d

  • Duration: 12 weeks


Control group
  • Placebo


Co‐interventions
  • Treatment group: vitamin D (71%); phosphate binders (100%)

  • Control group: vitamin D (60%); phosphate binders (80%)

Outcomes
  • Pharmacodynamic data at doses > 100 mg

  • Adverse effects

Notes
  • ITT: no

  • Funding: "From Pharmacokinetics and Drug Metabolism, Early Development, and Biostatistics, Amgen Inc, Thousand Oaks, CA; Orlando Clinical Research Center, Orlando, FL; and Clinical Research Center, New Orleans, LA"

  • Not included in meta‐analyses

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NS
Allocation concealment (selection bias) Unclear risk NS
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NS
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up 59.1% of patients
Selective reporting (reporting bias) High risk Not reported systematically (end of treatment calcium, phosphorous, PTH and adverse events)
Other bias High risk Sponsor on authorship