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

Primary hyperparathyroidism: Short-term calcimimetics treatment – Relevance for parathyroid surgery decisions?

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005374-57-SE

Enrollment

100

Registered

2012-12-18

Start date

2013-02-15

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 14.1 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860

Interventions

Trade Name: Mimpara Product Name: Mimpara Pharmaceutical Form: Tablet INN or Proposed INN: CINACALCET CAS Number: 226256-56-0 Concentration unit: mg/g milligram(s)/gram Concentration type: not less th

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 •To assess if the ionized calcium level will be normalized during four weeks of treatment with Mimpara 30 mgx1 •To assess the safety during Mimpara treatment •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 •To compare changes in quality of life, psychological health, cognitive function and muscle strength during treatment with Mimpara (M+) with postoperative changes ;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	—

Measure

Time frame

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 •To assess if the ionized calcium level will be normalized during four weeks of treatment with Mimpara 30 mgx1 •To assess the safety during Mimpara treatment •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 •To compare changes in quality of life, psychological health, cognitive function and muscle strength during treatment with Mimpara (M+) with postoperative changes ;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

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Secondary

Measure	Time frame
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 •Depression; evaluated with the Hospital Anxiety and Depression (HAD) scale during Mimpara treatment and postoperatively •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 •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 ;Timepoint(s) of evaluation of this end point: 4, 6 weeks, 6 months	—

Measure

Time frame

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 •Depression; evaluated with the Hospital Anxiety and Depression (HAD) scale during Mimpara treatment and postoperatively •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 •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 ;Timepoint(s) of evaluation of this end point: 4, 6 weeks, 6 months

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Countries

Sweden

Contacts

Public ContactInga-Lena Nilsson

Department of Breast and Endocrine Surgery, Karolinska University Hospital

inga-lena.nilsson@ki.se+460851773111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026