se of calcimimetics in primary hyperparathyroidism to predict the outcome of parathyroid surgery

Phase 1

Conditions: Primary hyperparathyroidism (PHPT) is a common disease, characterized by a high-normal calcium concentration and an inappropriately increased parathyroid hormone (PTH) level
MedDRA version: 14.1Level: LLTClassification code 10036693Term: Primary hyperparathyroidismSystem Organ Class: 100000004860
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-005374-57-SE

Lead Sponsor: Department of Breast and Endocrine Surgery, Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

•Primary hyperparathyroidism, scheduled for parathyroid surgery
•Woman (part A only)
•Age > 40
•Understand the purpose of the study, able to participate in all tests included in the study model
•Signed informed consent

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy
•Breast feeding
•Fertile woman not using contraceptives
•Impaired kidney function, GFR < 40 ml/min
•Intolerance to Mimpara
•Previously treated with Mimpara
•Participating in other ongoing clinical study
•Epilepsy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the relevance of short-term calcimimetics treatment in primary hyperparathyroidism for decision of parathyroid surgery ;Secondary Objective: •To assess the feasibility of the study design<br>•To assess if the ionized calcium level will be normalized during four weeks of treatment with Mimpara 30 mgx1 <br>•To assess the safety during Mimpara treatment<br>•To compare changes in quality of life, psychological health, cognitive function and muscle strength between patients with PHPT randomized to treatment with Mimpara (M+) or not (M-) preoperatively<br>•To compare changes in quality of life, psychological health, cognitive function and muscle strength during treatment with Mimpara (M+) with postoperative changes<br>;Primary end point(s): •If four weeks of treatment with Mimpara will normalize hypercalcemia in patients with PHPT ;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Changes in quality of life in view of the physical symptoms and well-being, evaluated with two validated forms (QLQ-C30 and the Positive States of Mind (PSOM)) during Mimpara treatment and postoperatively<br>•Depression; evaluated with the Hospital Anxiety and Depression (HAD) scale during Mimpara treatment and postoperatively<br>•Muscle strength; repeated ascent from a chair, repetitive stand up on tiptoes (measures the number which can be carried out) and thigh and hand strength evaluated by simple dynamometric apparatus during Mimpara treatment and postoperatively<br>•AE/SAE recording and safety blood samples; serum levels of (p)-PTH, serum(s)-ionized serum calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D and thyroid-stimulating hormone (TSH) during Mimpara treatment and postoperatively<br>;Timepoint(s) of evaluation of this end point: 4, 6 weeks, 6 months