Denocina

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-001510-20-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified