Clinical Trials

 

2014 - Oral PTH 1-84 study  - still recruiting

A new oral form of PTH 1-84 is  to be trialled in Norwich by our lead advisor, Professor Bill Fraser, as a potential treatment for hypoparathyroidism.Please click here to see further details and to sign up to this trial (members only).

The toxicology study for an oral PTH 1-34 is now underway 

http://www.hra.nhs.uk/news/research-summaries/oral-pth-1-34-in-the-treatment-of-hypoparathyroidism/

 

2010 - First UK clinical study on PTH 1-84

The first clinical study  into the use of parathyroid hormone (PTH 1-84) for the treatment of Hypoparathyroidism, was carried out in the UK in 2010 as part of a global study sponsored by NPS Pharmaceuticals Inc. The trial has now ended - see results here. To see what it was all about please click here and see below.

We are very grateful to Professor Bill Fraser who ran the trial and to research nurse Ya-Wen Jessica Huang. Our deepest thanks go to all our members who so kindly participated.

 

FAQ's on Clinical Trials

A downloadable and printable PDF booklet on the questions frequently asked by those thinking of joining a clinical trial has been produced by the European Genetic Alliances Network (EGAN) and Roche.

A new website explaining patients' view of clinical trials has been developed by Alastair Kent of the Genetic Alliance UK, and Roche. It contains patient videos and advice for those thinking about the benefits and risks of being involved in these trials. It's definitely worth a look!

Another resource that you might wish to consult for an even wider range of patient experience is http://www.healthtalkonline.org/medical_research/

 

Other trials which are currently recruiting:

 

Characterization of Patients With Non-surgical Hypoparathyroidism and Pseudohypoparathyroidism - Denmark

The aim of the study is to perform a detailed clinical and genetic characterization of Danish patients with idiopathic hypoPT and Ps-hypoPT. Patients will be examined by questionnaires, biochemistry, scans, bone biopsies and genetic tests. Furthermore the investigators aim to perform family tracing for the hereditary forms. The prevalence of magnesium depletion will be assessed as well.

In addition to providing new information on symptoms, co-morbidity, and prognosis for this group of patients, the investigators presume that the study may improve their understanding on calcium homeostasis and bone metabolism in general.

 

PARADIGHM A Natural History Registry for Patients With Chronic Hypoparathyrodism (PARADIGHM) - USA

This is a prospective, observational, natural history registry, designed to collect data on patients with chronic hypoparathyroidism. No study-defined procedures will be required, and if available, a select set of data will be collected at baseline and at least annually.

  

PTH 1-34 trial , NIH, Maryland, USA

The purposes of this 5 year study are to better understand the effects of hypoparathyroidism on the skeleton and to evaluate the effects of parathyroid hormone replacement therapy on bone in hypoparathyroidism. To read more please click here

 

Completed trials:

Parathyroid Allo-transplantation With a New Technique - Istanbul, Turkey May 2104

Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.

 

Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

This study by Dr Karen Winer evaluated the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump therapy will require lower PTH doses and should normalize markers of bone turnover. We expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.

 


Use of NPSP558 in the Treatment of Hypoparathyroidism (REPLACE) - global

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

 

Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 - Maryland USA

This study by Dr Karen Winer ran from 1991 to 2014. It has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.

Read results here 


   
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