Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2013-001890-26-IT
• Date of registration: 27/03/2014
• Prospective Registration: Yes
• Primary sponsor: Dipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di Firenze
• Public title: Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism
• Scientific title: Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism
• Date of first enrolment: 06/05/2014
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001890-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Italy

Contacts

• Name: SOD Malattie metabolismo minerale e
• Affiliation: Azienda Ospedaliero-Universitaria Careggi

• Name: SOD Malattie metabolismo minerale e
• Affiliation: Azienda Ospedaliero-Universitaria Careggi

Key inclusion & exclusion criteria

Inclusion criteria:
1.History of hypoparathyroidism for = 18 months post-diagnosis, inclusive of historical biochemical evidence of hypocalcaemia and concomitant serum intact PTH <1,3 pmol/L
2.Requirement for supplemental oral Ca treatment = 1000 mg per day over and above normal dietary Ca intake.
3.Capability of providing written informed consent.
4.Ability to perform daily subcutaneous self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh or abdomen.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
2.Any disease that might affect Ca metabolism or Ca/Pi homeostasis other than hypoparathyroidism.
3.Use of prohibited medications such as loop diuretics, raloxifene hydrochloride, lithium, estrogens, progestins, methotrexate, or systemic corticosteroids within clinical trial optimization and treatment periods.
4.Epilepsy.
5.Seizure disorder with a history of a seizure within the previous 6 months before the study.
6.Presence of open epiphyses.
7.Any disease/condition that in the opinion of the Investigator has a high probability of precluding the patient from correctly following study requirements and/or completing the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Refractory hypoparathyroidism
MedDRA version: 16.1 Level: PT Classification code 10021041 Term: Hypoparathyroidism System Organ Class: 10014698 - Endocrine disorders

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: FORSTEO
Product Name: FORSTEO
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232-67-4
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: range
Concentration number: 20-40

Primary Outcome(s)

Main Objective: Primary objective:
Evaluation of the effectiveness of subcutaneous administration of Teriparatide (FORSTEO) as hormone replacement therapy in patients with refractory hypoparathyroidism.

Secondary Objective: Secondary Objectives:
1) Determination of a more effective treatment than those presently used for patients with refractory hypoparathyroidism.
2) Creation of treatment guidelines for the use of Teriparatide in patients with refractory hypoparathyroidism.

Timepoint(s) of evaluation of this end point: 3 months

Primary end point(s): 1) to reduce requirements oral Ca and active vitamin D metabolite/analog supplementation administration
2) to maintain stable serum Ca levels
3) to control hypercalciuria 24/h

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 3 months

Secondary end point(s): 1) To evaluate the percentage change from Visit 1 in calcium supplementation dosage after 12 weeks of treatment with Teriparatide
2) The frequency of hypocalcemia clinical symptoms during treatment period.

Secondary ID(s)

TRACTOR

Source(s) of Monetary Support

AIFA (Italian Agency on Medicines)