Oral PTH (1-34) in the treatment of hypoparathyroidism
Research type
Research Study
Full title
A Pilot Study to Assess the Safety and Efficacy of Oral PTH (1-34) in the treatment of Hypoparathyroidism
IRAS ID
135642
Contact name
William Fraser
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eudract number
2013-003055-38
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Hypoparathyroidism is an uncommon disorder caused by insufficient levels of parathyroid hormone and characterized by hypocalcaemia and elevated phosphate in the blood. There are numerous causes of hypoparathyroidism, the most common being intentional or unintentional damage/ removal of the parathyroid glands as a result of head and neck surgery. The other causes of hypoparathyroidism are usually idopathic, with some resulting from known genetic disorders. Most of the clinical symptoms of hypoparathyroidism are due to the resulting hypocalcemia and include: weakness, muscle cramps, abnormal sensations such as tingling; burning and numbness (paresthesias) of the hands; excessive nervousness; loss of memory; headaches and uncontrollable cramping muscle movements of the wrists and feet. At present PTH replacement or supplements can only be provided by the parenteral route (SC PTHor, Forteo® or Forsteo®, In Europe, Preotact (a drug given as SC PTH (1-84)for osteoporoses has been approved).
Entera Bio has developed a new oral preparation of PTH which could be easier to administer and better tolerated than standard parenteral preparations. Additionally, an oral preparation lends itself to easy dose adjustment, thus allowing for custom and optimized treatment of the heterogeneous hypoparathyroid population. This study is part of a program to evaluate safety, efficacy and pharmacology of this new oral PTH preparation in hypoparathyroid patients.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0287
Date of REC Opinion
23 Sep 2013
REC opinion
Favourable Opinion