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

Study Overview
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Brief Summary
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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).

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

Conditions
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Primary Hyperparathyroidism, Bone Metabolism

Intervention / Treatment
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* Drug: Calcium and vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium and vitamin D<br>Intervention | Drug: Calcium and vitamin D<br>* 1000mg calcium per day 800 IE vitamin D per day<br>|
| No Intervention: No treatment (control)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroid hormone |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative follow-up