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

NCT00973336 | Unknown Phase 2

• 1 other identifier: PHPT02_2008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Hyperparathyroidism; Bone Metabolism

Keywords

postoperative follow-up

Outcome Measures

Primary Outcomes (1)

• Parathyroid hormone

  1 year

Secondary Outcomes (3)

• BMD of lumbar spine, femoral neck and radius

  1 year

• Adverse effects calcium or vitamin D

  1 year

• Other biochemical markers of bone metabolism

  1 year

Study Arms (2)

Calcium and vitamin D

EXPERIMENTAL

Intervention

Drug: Calcium and vitamin D

No treatment (control)

NO INTERVENTION

Interventions

Calcium and vitamin D DRUG

1000mg calcium per day 800 IE vitamin D per day

Calcium and vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women
• Male patients
• Biochemically proven PHPT, PTX planned
• No evidence for osteoporosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bruno Niederle, Prof., MD

  Medical University of Vienna, Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Riss, MD

CONTACT

+43140400; philipp.riss@meduniwien.ac.at

Bruno Niederle, Professor, MD

CONTACT

+43140400; chir-endokrin@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

AU (1)