Clinical Trials Logo

Clinical Trial Summary

The aim of the study is to assess whether PTH (1-84) therapy posses advantages compared to conventional treatment in patients with hypoparathyroidism on muscle function, quality of life, calcium homeostasis, bone metabolism, and body composition.


Clinical Trial Description

Hypoparathyroidism is one of the only hormonal insufficiency states that is usually not treated by replacing the missing hormone. Currently, Standard therapy includes treatment with calcium and an 1alpha-hydroxylated forms of vitamin D (e.g. calcitriol or alphacalcidol) in order to relieve the symptoms associated with hypocalcaemia. However, recent studies have shown that calcium homeostasis can be well regulated by PTH replacement therapy in patients with hypoparathyroidism. It seems that PTH treatment is safe and that it even may posses advantages compared to conventional treatment with vitamin D. As the renal calcium excretion is decreased by PTH therapy, the risk of renal calcifications causing an impaired renal function may be reduced. In addition, some of the hypoparathyroid patients treated with PTH reported less fatigue and increased endurance in response to treatment. This may be due to either a better regulated (i.e. more physiological) calcium homeostasis during PTH therapy, or due to a direct effect of PTH on the neuromuscular system. Therefore, further studies are needed on the effects of PTH replacement in patients with hypoparathyroidism.

Outcome measures:

- Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). In addition, effects of treatment on muscle function are assessed through muscle biopsies, electromyographic, echocardiography, and by biochemical measures (muscle enzymes).

- Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the WHO-Five Well-Being Index (WHO-5)-survey.

- Calcium homeostasis, bone metabolism, and body composition. Effects of treatment are assessed by measurements of calcitropic hormones, biochemical markers of bone turnover, and iliac crest biopsies. In addition, bone mineral density and body composition is measured. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00730210
Study type Interventional
Source University of Aarhus
Contact
Status Completed
Phase Phase 2
Start date June 2008
Completion date August 2010

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
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 NCT03747029 - Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Recruiting NCT05684029 - Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
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
Completed NCT00793689 - Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy N/A
Completed NCT04671719 - Determination of Circulating Autotaxin in Patients With GNAS or PTH Abnormalities
Completed NCT04750460 - Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa). Phase 3