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

This study is currently recruiting participants.
Verified April 2012 by Medical University of Vienna
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00973336
First received: September 8, 2009
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Primary Hyperparathyroidism
Bone Metabolism
 Drug: Calcium and vitamin D
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteopenia or Osteoporosis?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Parathyroid hormone [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMD of lumbar spine, femoral neck and radius [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse effects calcium or vitamin D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Other biochemical markers of bone metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973336

Contacts
Contact: Philipp Riss, MD +43140400 ext 5621 philipp.riss@meduniwien.ac.at
Contact: Bruno Niederle, Professor, MD +43140400 ext 6943 chir-endokrin@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Philipp Riss, MD     +43140400 ext 5621     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            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Bruno Niederle, Prof., MD Medical University of Vienna, Department of Surgery
  More Information

No publications provided

Responsible Party: Univ. Prof. Dr. Bruno Niederle, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00973336     History of Changes
Other Study ID Numbers: PHPT02_2008
Study First Received: September 8, 2009
Last Updated: April 19, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
postoperative follow-up

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013