Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?

Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?

Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.

Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).

Study Overview

• Status: Unknown
• Conditions: Primary Hyperparathyroidism; Bone Metabolism
• Intervention / Treatment: Drug: Calcium and vitamin D

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Philipp Riss, MD; Phone Number: 5621 +43140400; Email: philipp.riss@meduniwien.ac.at
• Study Contact Backup: Name: Bruno Niederle, Professor, MD; Phone Number: 6943 +43140400; Email: chir-endokrin@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Philipp Riss, MD; Phone Number: 5621 +43140400; Email: philipp.riss@meduniwien.ac.at
    • Sub-Investigator: Philipp Riss, MD
    • Principal Investigator: Bruno Niederle, Prof., MD
    • Sub-Investigator: Reza Asari, MD
    • Sub-Investigator: Christian Scheuba, MD
    • Sub-Investigator: Katharina Kerschan-Schindl, Prof., MD
    • Sub-Investigator: Peter Pietschmann, Prof., MD
    • Sub-Investigator: Christian Bieglmayer, Prof., PhD
    • Sub-Investigator: Martin B Niederle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Postmenopausal women
• Male patients
• Biochemically proven PHPT, PTX planned
• No evidence for osteoporosis

Exclusion Criteria:

• Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
• Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
• Persisting or recurrent PHPT (postoperative hypercalcemia)
• Four-gland hyperplasia
• Multiple endocrine neoplasia (MEN) or hereditary PHPT
• Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
• Phenylketonuria
• Renal impairment (creatinine clearance <30ml/h)
• Severe hepatic disorder
• Severe systemic disorder
• Thyroid dysfunction
• Immobilisation
• Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
• Intake of drugs containing digoxin or digitoxin
• Known allergy against any component of the study medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Calcium and vitamin D; Intervention	Drug: Calcium and vitamin D; 1000mg calcium per day 800 IE vitamin D per day
NO_INTERVENTION: No treatment (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parathyroid hormone	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
BMD of lumbar spine, femoral neck and radius	1 year
Adverse effects calcium or vitamin D	1 year
Other biochemical markers of bone metabolism	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Bruno Niederle, Prof., MD, Medical University of Vienna, Department of Surgery

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (ESTIMATE): September 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: postoperative follow-up
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: PHPT02_2008