Clinical Trials Logo
  1. Home
  2. Hypoparathyroidism
  3. NCT01268098

Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Hypoparathyroidism Clinical Trial

Official title:
A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism

Clinical Trial Summary

Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Clinical Trial Description

Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01268098
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date February 9, 2011
Completion date November 11, 2011
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03364738 - Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism Phase 3
Active, not recruiting NCT00856401 - ADD-ON Study to Existing Hypoparathyroidism Studies Phase 3
Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
Completed NCT03728959 - Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism. N/A
Not yet recruiting NCT06445036 - Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.
Recruiting NCT05556629 - A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
Terminated NCT00395538 - Effects of PTH Replacement on Bone in Hypoparathyroidism Phase 3
Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
Completed NCT00001304 - Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 Phase 2
Completed NCT04569604 - QoL and Cognitive Function in Patients With Hypoparathyroidism
Completed NCT06449729 - Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism
Completed NCT03747029 - Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Completed NCT05684029 - Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
Not yet recruiting NCT06419270 - Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Completed NCT00473265 - Bone Properties in Hypoparathyroidism: Effects of PTH Phase 2/Phase 3
Active, not recruiting NCT05328076 - Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
Completed NCT03150108 - Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects Phase 1
Completed NCT04059380 - Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1