Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Greek

NCT07160348 | Not Yet Recruiting

• 1 other identifier: 8802
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a crossectional study that will be conducted at several tertiary centers in Greece. To participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \>12 months. Exclusion criteria will include:

1. 1.Patients inadequately controlled with conventional therapy:
2. 2.corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia
3. 3.serum P \>5.5 mg/dl
4. 4.Age \>80 years
5. 5.Presence of neoplastic disease
6. 6.Pregnancy
7. 7.Diagnosis of psychiatric disease or cognitive impairment
8. 8.Participants experiencing other comorbidities that may affect QoL
9. 9.Lack of informed consent The study will seek approval from the Ethics in Research Committee of its participating center. All participants will be informed about the objectives of the study and will sign an informed consent.

Conditions

Hypoparathyroidism

Keywords

hypoparathyroidism; parathyroid hormone; palopegteriparatide; calcium metabolism disorders

Outcome Measures

Primary Outcomes (2)

• Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek

  To translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with chronic hypoparathyroidism for use in the Greek population

  6 months

• Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek

  To translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with chronic hypoparathyroidism for use in the Greek population

  12 months

Study Arms (1)

Patients diagnosed with chronic hypoparathyroidism

Patients ≥18 years of age, fluent in Greek language, diagnosed with chronic hypoparathyroidism (HP), on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \>12 months.

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam OTHER

Translation and validation of the existing HPES-Symptom and HPES-Impact Questionnaires in the Greek population

Patients diagnosed with chronic hypoparathyroidism

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic hypoparathyroidism ≥18 years of age

You may qualify if:

• Patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \>12 months.

You may not qualify if:

• Patients inadequately controlled with conventional therapy:
• corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia
• serum P \>5.5 mg/dl
• Age \>80 years
• Presence of neoplastic disease
• Pregnancy
• Diagnosis of psychiatric disease or cognitive impairment
• Participants experiencing other comorbidities that may affect QoL
• Lack of informed consent

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• National and Kapodistrian University of Athens: collaborator
• 424 General Military Hospital: collaborator
• General Hospital Of Thessaloniki Ippokratio: collaborator
• Laikο General Hospital, Athens: collaborator
• 251 Hellenic Air Force & VA General Hospital: collaborator
• Hellenic Red Cross Hospital: collaborator

Related Publications (2)

• Khan AA, Rejnmark L, Rubin M, Schwarz P, Vokes T, Clarke B, Ahmed I, Hofbauer L, Marcocci C, Pagotto U, Palermo A, Eriksen E, Brod M, Markova D, Smith A, Pihl S, Mourya S, Karpf DB, Shu AD. PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e372-e385. doi: 10.1210/clinem/dgab577.

  PMID: 34347093 BACKGROUND

• Khan AA, Bilezikian JP, Brandi ML, Clarke BL, Gittoes NJ, Pasieka JL, Rejnmark L, Shoback DM, Potts JT, Guyatt GH, Mannstadt M. Evaluation and Management of Hypoparathyroidism Summary Statement and Guidelines from the Second International Workshop. J Bone Miner Res. 2022 Dec;37(12):2568-2585. doi: 10.1002/jbmr.4691. Epub 2022 Nov 14.

  PMID: 36054621 BACKGROUND

MeSH Terms

Conditions

Hypoparathyroidism; Calcium Metabolism Disorders

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08