Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism

Launched by ISTITUTO AUXOLOGICO ITALIANO · Apr 11, 2015

Keywords

ClinConnect Summary

The project was conducted at the Istituto Auxologico Italiano, IRCCS, Milano (Italy).

Principal Investigator: Maria Luisa Bianchi, M.D., Nephrologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy

Other investigators:

Silvia Vai, M.D., endocrinologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy Francesca Broggi, Dr., biologist, Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Milan, Italy Luca Persani, M.D., Endocrinologist, University of Milan \& Division of Endocrine and Metabolic Diseases, Istituto Auxologico Italiano IRCCS...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. patients affected by moderate to severe PHP without instrumental (echography, neck CT, scintigraphy with Sestamibi) evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and previously surgically treated, but recidivating without instrumental evidence of parathyroid adenoma or hyperplasia; OR patients affected by PHP and judged inoperable because of other pathologies
• • 2. patients with serum total calcium between 10.5 and 12.5 mg/dl (inclusive)
• • 3. males: age ≥50 years; females: age ≥50 years, in menopause for at least 2 years;
• • 4. patients with reduction of bone density (T-score ≤ -2 at spine OR hip, by DXA scan)
• • 5. informed consent signed at enrolment
• Exclusion Criteria:
• • 1. lack of informed consent;
• • 2. presence of other diseases known to cause hypercalcemia (e.g. familial benign hypercalcemia);
• • 3. previous or ongoing therapies interfering with calcium and bone metabolism;
• • 4. impaired liver and/or renal function (i.e. serum aspartate aminotransferase, alanine aminotransferase and total bilirubin twice the upper limit of normal or more; creatinine clearance lower than 60 ml/min);
• • 5. history of seizures, malignancy, myocardial infarction;
• • 6. previous exposure to cinacalcet.