PAR-R13-001: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients with Chronic Hypoparathyroidism

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, Non-interventional Study (Registry)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA03) parathyroid hormone

  parathyroid hormone
• Medical condition to be studied:
  Hypoparathyroidism

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with hypoparathyroidism
• Estimated number of subjects:
  1339

Study design details

• Main study objective:
  To characterize and describe the long-term safety and effectiveness profile of rhPTH(1-84) treatment in patients with chronic hypoparathyroidism under conditions of routine clinical practice.
• Outcomes:
  - Hypoparathyroidism Laboratory Test - Renal Function - Incidence Rate of the Renal Events - Incidence Rate of the Soft Tissue Calcifications (site) - Incidence Rate of the Cataract - Incidence Rate of the Bone Fractures (site) - Incidence Rate of the Cardiovascular Events - Number of Participants With Adverse Events and Serious Adverse Events, - Health-related Quality of Life (HRQoL) - Disease-specific Patient-reported Outcome Measures - Rate of Hospitalization/Emergency Room (ER) Visits
• Data analysis plan:
  Data will primarily be summarized with descriptive statistics comprising the number of observations (n), mean, standard deviation, median, minimum, and maximum for continuous variables, and counts and percentages for categorical variables. Person-years of follow-up and incidence rates of prospective events will be calculated.