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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001890-26-IT

Enrollment

Registered

2014-03-27

Start date

2014-05-06

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.History of hypoparathyroidism for = 18 months post-diagnosis, inclusive of historical biochemical evidence of hypocalcaemia and concomitant serum intact PTH =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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. ;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 ;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Italy

Contacts

Public ContactSOD Malattie metabolismo minerale e

Azienda Ospedaliero-Universitaria Careggi

marialuisa.brandi@unifi.it0039055794 8087

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026