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

Phase 1

Conditions: Refractory hypoparathyroidism
MedDRA version: 16.1Level: PTClassification code 10021041Term: HypoparathyroidismSystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2013-001890-26-IT

Lead Sponsor: Dipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di Firenze

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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.