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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00973336
• Other study ID #: PHPT02_2008
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2009
• Last updated: March 14, 2016
• Start date: September 2009
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Medical University of Vienna
• Contact: Philipp Riss, MD
• Phone: +43140400
• Email: philipp.riss[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Metabolism
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Drug:
• Calcium and vitamin D
1000mg calcium per day 800 IE vitamin D per day

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parathyroid hormone		1 year	No
Secondary	BMD of lumbar spine, femoral neck and radius		1 year	No
Secondary	Adverse effects calcium or vitamin D		1 year	No
Secondary	Other biochemical markers of bone metabolism		1 year	No