The PARADIGHM (physicians advancing disease knowledge in hypoparathyroidism) registry for patients with chronic hypoparathyroidism: study protocol and interim baseline patient characteristics

Table 2 Data collection schedule

Parameter	Baseline visit	Follow-up visit
Inclusion/exclusion criteria	×
Informed consent, medical records release, and contact order form	×
Demographics^a	×
Other study participation	×	×
Hypoparathyroidism etiology (primary cause)^b	×
Family history	×
Medical history/condition summary	×
Height and weight	×	×
Pregnancy	×	×
Clinical laboratory evaluations	×	×
Other medical procedures^c	×	×
Management of chronic hypoparathyroidism	×	×
rhPTH(1-84) dosing information^d	×	×
Historical PTH dosing information^e	×
Prior and concomitant medications, including over-the-counter medications	×	×
Outcome evaluations (socioeconomic status and social history)	×
Outcome evaluations (Hypoparathyroidism Symptom Diary, WPAI:SHP, SF-36, SF-10)	×^f	×
Other questionnaires (signs and symptoms, hospitalization annual form)	×	×
Vital status database searches		×^g
Adverse events	×^f,h	×
Patient discontinuation		×

PTH parathyroid hormone, rhPTH(1-84) recombinant human parathyroid hormone (1-84), SF-10 10-Item Short Form Health Survey questionnaire for pediatric patients, SF-36 36-Item Short Form Health Survey questionnaire for adults, WPAI:SHP Work Productivity and Activity Impairment Specific Health Problem
^aFor example, month and year of birth, age
^bGenetic mutation, surgery-induced, autoimmune, radiation, idiopathic, other
^cFor example, dual-energy x-ray absorptiometry, imaging, bone biopsies
^dRefers to the use of rhPTH(1-84) (Natpar®/Natpara®)
^eRefers to the use of rhPTH(1-84) (Preotact®) or rhPTH(1-34) (Forteo®)
^fDiscrepancy from November 2017 protocol to be corrected in future amendments
^gSearch is only performed if patient is a US patient lost to follow-up or reported deceased
^hClassification was at investigator discretion after the signing of the informed consent form (ie, adverse events should not be historical events before enrollment)

ISSN: 1472-6823