Primary Hyperparathyroidism. Patients included will have Osteopenia/Osteoporosis with a T-score between -1,0 and 3,5. MedDRA version: 20.0 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Mimpara
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CINACALCET
CAS Number: 226256-56-0
Concentration unit: mg mi
Sponsors
Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women of 18 years of age or older. • T-score by DXA between -1,0 og -3,5. • Patients from The North Jutland Region diagnosed with primary hyperparathyroidism at departments of endocinology in hospitals of the North Jutland Region. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Medical history of diseases leading to hypercalcaemia other than Primary Hyperparathyroidism. • Patients being treated with Denosumab or Cinacalcet prior to inclusion. • Moderatly - Severely decreased liver function (ALAT >250u/l, GGT>150u/l, Bilirubin >30) • AMI or apoplexia within 3 months before inclusion. • Medical record of heartfailure. • Risk factors of prolonged QTc-interval. • Open lesions from oral surgery. • Primary diseases of the bone other than osteoporosis. • Patients suffering from kidney disease or renal failure. • Patients under treatment with thiazide or lithium. • Medical record of generalized seizures or epilepsia. • Active malignant disease. • Known allergies towards the specified IMP's. • Pregnancy or breastfeeding. • Fertile women who do not agree to the usage of effective anticonception. • Other circumstances, evaluated by the responsible investigator, making the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of Denosumab alone, and in combination with Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism, with mild osteoporosis. Patients included do not meet the criteria for, or have no wish for a surgical procedure. The main endpoints will be the effect of treatment on BMD and bone structure measured by DXA, VFA and QCT. Calcifications and the effect of treatment here on, in coronary arteries, the pancreas and kidneys will also be evaluated. ; Primary end point(s): Change of Bone Mass Density in percentage after one year of treatment, for the subgroups as a whole from baseline, and in comparison between subgroups treated with IMP vs placebo. ; Timepoint(s) of evaluation of this end point: DXA, VFA and QCT will be performed at baseline and after one year of treatment (termination). Data will be evaluated mainly after termination of treatment. Results are expected evaluated by the beginning of spring 2019. ; Secondary Objective: Other objectives will be to investigate the effects of the treatment on,and general development in biochemical markers of bone turnover, levels of plasma- and urine -calcium and phosphorous. The condition's impact on cortical and trabecular bonetissue will be evaluated at baseline, and compared with the development after one year. Symptoms of disease and treatment, comorbidities, and the medical history of the included subjects are also points of interest. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in vBMD, BMC, cortical and trabecular width and ratio between these. -Changes in s-calcium and s-intact parathyroid hormone over time until after one year of treatment. - Changes in markers of bone turnover in blood and urine. - The prevalence of, and changes over time of coronary calcification by agatston-score. - Development and prevalence of nephrolithiasis/nephrocalcinosis by computed tomography. - Development and prevalence of pancreatic calcifications by computed tomography. - Reset of the Ca-SR?: measured from effect on s-calcium and PTH 2 weeks after termination of IMP.- By Vertebral Fracture Assessment (VFA) development and prevalence of osteoporotic fractures of the column is assessed. ; Timepoint(s) of evaluation of this end point: CT, VFA and DXA will be performed at baseline and at the termination of the project. Markers of bone metabolism will be measured a total of 6 times throughout the year. Urine samples will be collectedat baseline, after 24 weeks, and at termination. Other biochemical tests will be measured monthly through the whole project. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Endocrinology
Aalborg University Hospital
Outcome results
None listed