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Hypoparathyroidism
Awareness Ambassador

PARADIGHM™: A Natural History Registry for Patients
with Chronic Hypoparathyroidism

What is PARADIGHM™?

PARADIGHM™ is a recently initiated global natural history registry designed to study the long-term effects of chronic hypoparathyroidism, a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone (PTH), the principal regulator of calcium and phosphate. Hypoparathyroidism can cause a multitude of serious symptoms, including uncontrollable muscle spasms and cramps, tetany, tingling, seizures, fatigue, anxiety, depression, and kidney stones.

Why is PARADIGHM™ needed?

Currently, there is limited data about the long-term complications and risks of hypoparathyroidism. PARADIGHM™ was created to help fill this scientific need by better defining the natural history of chronic hypoparathyroidism, including its treatment, clinical outcomes, comorbidities, and mortality as observed in a standard medical practice.

What is the goal of PARADIGHM™?

The goal of PARADIGHM™ is to provide healthcare practitioners with greater knowledge of the variability, progression, and natural history of this rare disorder to help optimize their clinical decision-making and improve patient outcomes.

Who can participate?

The PARADIGHM™ registry is open to investigators treating patients with chronic hypoparathyroidism of at least 6 month’s duration, regardless of age, gender, cause of the disorder or how it is being managed.

Are any patients not eligible?

Patients diagnosed with transient hypoparathyroidism within six months of enrollment are not eligible for the PARADIGHM™ registry.

What are the study procedures?

Patients in the PARADIGHM™ registry will be enrolled and followed for a minimum of 10 years under conditions of normal clinical practice. Patient questionnaires will be used to collect patient data upon enrollment, as well as annually if the patient agrees to participate. Most data is derived from information collected in medical records during normal care.

Is information confidential?

Personal medical information collected about patients will be kept confidential to the extent possible. No information will be shared with outside sources except for the conduction of the registry, as required by law or patient protection committees.

How can HCPs support the registry?

Helping populate the registry with as many eligible patients as possible is critical to the success of PARADIGHM™. HCPs can inform their patients of the importance of PARADIGHM™, and help them decide if enrolling is the right step.

What are the benefits for investigators?

The PARADIGHM™ study will provide much-needed data on incidence, prevalence, risk factors, comorbidity, management modalities, and mortality in order to assist practitioners in their clinical decision-making.

How are patients enrolled?

Patients can enroll at participating study centers or they can enroll through their physician. If patients enroll through their doctor, data will be collected via review of medical records and completion of questionnaires.

How can you learn more?

For more information about the PARADIGHM™ registry, contact NPS Pharma at:
Email NPS Pharma clinical operations
Visit ClinicalTrials.gov
or the Registry of Patient Registries

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