Danish patients may now participate in PTH Clinical Trial.

Danish Phase 3 registration study of PTH 1-84 (REPLACE) for the treatment of Hypoparathyroidism.

Danish clinical study in the use of parathyroid hormone (PTH 1-84) for the treatment of Hypoparathyroidism (HPTH) has begun enrollment in Aarhus, Copenhagen and Odense. This is part of a worldwide study sponsored by NPS Pharmaceuticals, Inc.

This is an important milestone in the treatment of hypoparathyroidism worldwide.

If you have Hypoparathyroidism and would like to participate, you will find information about REPLACE by clicking here.

Please contact the nearest Study location or our association for further information.

It is an exciting time for the Nordic HPTH Organisation as we are working with NPS Pharmaceuticals to get information out to all Danish patients who have Hypoparathyroidism about the Phase III Clinical Trial, called REPLACE, which NPS is conducting at this time. A clinical phase III trial is one of the last steps before approval on the market.

Hypoparathyroidism is the ONLY endocrine disorder which does not have an FDA/EMEA approved hormone replacement therapy. We hope with this study that the hormone is approved Internationally for the treatment of HPTH.

If you have HPTH we encourage you to consider participation in this study.
You have a chance to become a part of the solution, as many of us have been waiting for, and give yourself a unique opportunity to help make a difference, not only in your life, but in the lives of countless HPTH patients around the world. After years of waiting for a more effective method of treatment of Hypoparathyroidism, we can finally see the light at the end of the tunnel.

Currently available treatments for hypoparathyroidism, which include life-long high-dose oral supplementation with calcium and active vitamin D metabolites or analogs, is to reduce the severity of symptoms; however, hypoparathyroidism and the use of oral calcium and vitamin D analogs/metabolites for symptom control can contribute to organ damage and calcification, which is particularly evident in the kidneys.

NPS Pharmaceuticals, which specializes in developing treatments for rare endocrine disorders, has begun patient enrollment for a Phase 3 trial, known as REPLACE, to assess NPSP558 for the treatment of adults with hypoparathyroidism. NPSP558 is a recombinant full-length parathyroid hormone (PTH 1-84), which mimics the action of natural parathyroid hormone.

The primary objective is to demonstrate, over a 24-week treatment period, that once-daily subcutaneous dosing with NPSP558 at doses of 50µg, 75µg or 100µg is a safe and effective hormone replacement therapy for the treatment of patients with Hypoparathyroidism.

REPLACE is a double-blind, placebo-controlled study that will randomize approximately 110 patients.

There are approximately 30 study locations in the USA, Canada, Belgium, France, Italy, England and Denmark.

 

In Denmark, the studies are carried out at Aarhus University Hospital, Odense University Hospital and Gentofte Hospital.

Contact Information in Denmark:

Aarhus University Hospital:

Professor Leif Mosekilde: +45 89 49 76 77 ext 697 leimos@rm.dk

Dr.med Lars Rejnmark: +45 89 49 76 51 rejnmark@post6.tele.dk

Odense University Hospital:

Dr.med Kim Brixen: +45 5120 9787 kbrixen@health.sdu.dk

Anette Riis Madsen: +45 6541 3536

anette.riis.madsen@ouhregionsyddanmark.dk

Gentofte Hospital:

Professor Bo Abrahamsen: +45 3977 3977 b.abrahamsen@physician.dk

Kirsten Abelin: +45 3977 7536 kiab@geh.regionh.dk

Nordic HPTH Organisation:

President: Helen Dahl-Hansen: helen.dahl-hansen@hpth.no

Representative in Denmark:
Vibeke Ingebrigtsen: vibeke.ingebrigtsen@mail.dk