Clinical Trials

The Association has always advocated participation in patient studies and other investigative medical initiatives.  Medical research and patient participation is necessary if medical science is to be advanced, and patient’s quality of life improved.

Hypoparathyroidism Air Way Study (new)

Christy Moore is a doctoral student at A.T. Still University, Arizona School of Health Science.  She is interested in researching the correlation between the parathyroid hormone and peak air flow.  For more information here is a pdf of her letter explaining the project and what you would have to do - Airway Study

This is an easy study to participate in from your home.  

Harvard Medical School

Drs. Michael Mannstadt and Harald Jueppner are conducting a study of causes of familial forms of hypoparathyroidism.  They are looking for participants in which at 2 members of their family are affected by hypoparathyroidism.  For more information, click here.

NIH Research Study:  PTH Replacement Study for Children with Hypoparathyroidism due to Autoimmune Polyglandular Failure

Dr. Karen Winer from the NIH is recruiting children and adolescents (10-19 years old) with hypoparathyroidism due to autoimmune polyglandular failure to participate in her PTH replacement study to compare injection and pump therapy. Three admissions to the NIH will be required over a six-month period.   Call her directly at 301-435-6877.

NIH Research Study: Effects of PTH Replacement on Bone in Hypoparathyroidism (07-D-0016)

Principal Investigator: Dr. Rachel Gafni, MD,

Sponsoring Institute: Craniofacial and Skeletal Diseases Branch, NIDCR, National Institutes of Health

The primary purpose of this research study is to evaluate the effects of synthetic parathyroid hormone 1-34 (PTH) replacement therapy on bone in adults with hypoparathyroidism.   After a 3-6 month period of calcium and calcitriol therapy, eligible subjects will be taken off of calcitriol and treated with PTH for 5 years, given as twice daily injections.   All study visits will be at the NIH Clinical Center in Bethesda, Maryland for a total of 12 visits over a 5 ½ year period.  Once PTH therapy has begun, follow-up inpatient or outpatient visits lasting from 2-10 days will be every 6 months. During the NIH visits participants will undergo several procedures, which may include blood tests, urine tests, x-rays, questionnaires, fitness tests, and removing a sample of bone from the hip (bone biopsy).  Laboratory tests at local laboratories will be required in between NIH visits to monitor therapy.   Transportation will be provided and there is no cost for participation or any tests performed at the NIH.  You may be eligible if you are between 18 and 50 years of age and have been diagnosed with hypoparathyroidism for at least one year.   For more information, please contact the NIH Patient Recruitment and Public Liaison hotline at 1-800-411-1222 or prpl@cc.nih.gov.  You can also go to our website to learn more about the study at www.www.hypoparathyroidstudy.org.

 NPS Patient Study   

Patient enrollment is underway in a Phase 3 registration study, known as REPLACE, to evaluate NPSP558 for the treatment of adults with hypoparathyroidism.  NPSP558 is a proprietary recombinant full-length human parathyroid hormone (PTH 1-84), which mimics the action of natural parathyroid hormone. There is currently no approved replacement therapy for hypoparathyroidism. The primary objective is to demonstrate, over a 24-week treatment period, that once-daily subcutaneous dosing with NPSP558 at doses of 50mcg, 75mcg or 100mcg is a safe and effective hormone replacement therapy for the treatment of patients with hypoparathyroidism. For more information on REPLACE, please contact NPS Pharmaceuticals, Inc. http://www.npsp.com/ or http://clinicaltrials.gov.

PTH1-84 Use Beyond the Conclusion of the CL1-11-040 Study and the Hypopara Study (aka "Hypo Extension Study")

Dr. John Bilezikian and his colleagues of Columbia University Medical Center are conducting a new study with hypoparathyroidism patients who have been treated with PTH(1-84). These patients will come from one of the follow 2 studies:

1)    The “Hypopara Study” that is being conducted at Columbia University Medical Center with Dr. Bilezikian or ,

2)    The “CL1-11 Study” sponsored by NPS Pharmaceuticals , and conducted at Columbia University and a number of other sites in the US and internationally.

The purpose of this “extension” study is to monitor the continued beneficial effects of PTH(1-84) as well as to monitor safety parameters.  

The study is designed to be two years long and utilizes PTH(1-84) in three different doses.  The dose begins at 50 micrograms (mcg) daily with the possibility of increasing to 75 and/or 100mcg as clinically necessary.  There is no placebo in this study.  All patients will treated with PTH(1-84).

To participate in the study you must have either, a) qualified for and completed at least 24-months participation using PTH1-84 in the Hypopara Study at Columbia University or, b) qualified for and completed the entire CL1-11 Study sponsored by NPS Pharmaceuticals at either Columbia University or any site within the continental US.

This study is conducted only at Columbia University Medical Center (CUMC) in New York City.  Participants will be expected to come to our offices at CUMC for a first visit (baseline) plus 4 additional visits (once every 6 months) over the next two years.  Additional laboratory tests may be required for safety purposes. Official reports of some laboratory tests can be accepted from outside laboratories.

Eligible participants will gain the advantage of continued treatment of their hypoparathyroidism with PTH(1-84) for an additional two years.

To learn more please contact Jim Sliney at js2040@columbia.edu or 212-305-7364.

To see if there are any other clinical trials taking place that we may not have heard of - check out the ClinicalTrials.gov website.