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

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ClinicalTrials.gov Identifier: NCT00973336
Recruitment Status : Recruiting
First Posted : September 9, 2009
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Primary Hyperparathyroidism Bone Metabolism Drug: Calcium and vitamin D Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Osteoporosis?
Study Start Date : September 2009
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arms and Interventions

Arm Intervention/treatment
Experimental: Calcium and vitamin D
Drug: Calcium and vitamin D
1000mg calcium per day 800 IE vitamin D per day
No Intervention: No treatment (control)

Outcome Measures

Primary Outcome Measures :
  1. Parathyroid hormone [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. BMD of lumbar spine, femoral neck and radius [ Time Frame: 1 year ]
  2. Adverse effects calcium or vitamin D [ Time Frame: 1 year ]
  3. Other biochemical markers of bone metabolism [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973336

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

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
Principal Investigator: Bruno Niederle, Prof., MD Medical University of Vienna, Department of Surgery
More Information

Responsible Party: Philipp Riss, Assistent Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00973336     History of Changes
Other Study ID Numbers: PHPT02_2008
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

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

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