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

Phase 2

• Conditions: Primary Hyperparathyroidism; Bone Metabolism
• Interventions: Drug: Calcium and vitamin D

• Registration Number: NCT00973336
• Lead Sponsor: Medical University of Vienna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium and vitamin D	Calcium and vitamin D	Intervention

Primary Outcome Measures

Name	Time	Method
Parathyroid hormone	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria