Back to results

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

Primary Purpose

Primary Hyperparathyroidism, Bone Metabolism

Status

Unknown status

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Calcium and vitamin D

Sponsored by

Medical University of Vienna

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring postoperative follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Calcium and vitamin D

No treatment (control)

Arm Description

Intervention

Outcomes

Primary Outcome Measures

Parathyroid hormone

Secondary Outcome Measures

BMD of lumbar spine, femoral neck and radius

Adverse effects calcium or vitamin D

Other biochemical markers of bone metabolism

Full Information

NCT ID

First Posted

September 8, 2009

Last Updated

March 14, 2016

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00973336

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hyperparathyroidism, Bone Metabolism

Keywords

postoperative follow-up

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Calcium and vitamin D

Arm Type

Experimental

Arm Description

Intervention

Arm Title

No treatment (control)

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Calcium and vitamin D

Intervention Description

1000mg calcium per day 800 IE vitamin D per day

Primary Outcome Measure Information:

Title

Parathyroid hormone

Time Frame

1 year

Secondary Outcome Measure Information:

Title

BMD of lumbar spine, femoral neck and radius

Time Frame

1 year

Title

Adverse effects calcium or vitamin D

Time Frame

1 year

Title

Other biochemical markers of bone metabolism

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philipp Riss, MD

Phone

+43140400

Ext

5621

Email

philipp.riss@meduniwien.ac.at

First Name & Middle Initial & Last Name or Official Title & Degree

Bruno Niederle, Professor, MD

Phone

+43140400

Ext

6943

Email

chir-endokrin@meduniwien.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Niederle, Prof., MD

Organizational Affiliation

Medical University of Vienna, Department of Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philipp Riss, MD

Phone

+43140400

Ext

5621

Email

philipp.riss@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Philipp Riss, MD

First Name & Middle Initial & Last Name & Degree

Bruno Niederle, Prof., MD

First Name & Middle Initial & Last Name & Degree

Reza Asari, MD

First Name & Middle Initial & Last Name & Degree

Christian Scheuba, MD

First Name & Middle Initial & Last Name & Degree

Katharina Kerschan-Schindl, Prof., MD

First Name & Middle Initial & Last Name & Degree

Peter Pietschmann, Prof., MD

First Name & Middle Initial & Last Name & Degree

Christian Bieglmayer, Prof., PhD

First Name & Middle Initial & Last Name & Degree

Martin B Niederle, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs