Primary hyperparathyroidism: does a systematic treatment improve the calcium and bone metabolism after successful surgery? – Part IISystematic treatment of patients with neither osteopenia nor osteoporosis after successful surgical treatment for primary hyperparathyroidism with Calcium and Vitamin D
- Conditions
- 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).MedDRA version: 9.1Level: LLTClassification code 10020707Term: Hyperparathyroidism primary
- Registration Number
- EUCTR2008-001704-23-AT
- Lead Sponsor
- Medizinische Universität Wien, Universitätsklinik für Chirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
•postmenopausal women
•male patients
•biochemically proven PHPT, PTX planned
•no evidence for osteoporosis or osteopenia (normal BMD)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Cancer (including thyroid or parathyroid cancer)
•Persisting or recurrent PHPT (postoperative hypercalcemia)
•Four-gland hyperplasia
•Multiple endocrine neoplasia (MEN) or hereditary PHPT
•Familial hypercalcuric hypercalcaemia (Ca/creatinine ratio < 0.01)
•Phenylketonuria
•Renal impairment (creatinine clearence <30ml/h)
•Severe hepatic disorder
•Severe systemic disorder
•Thyroid dysfunction
•Concomittant thyroid surgery
•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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does 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)?;Secondary Objective: ;Primary end point(s): Main outcome variables:<br><br><br><br><br><br><br><br>•PTH<br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br>Additional outcome variables:<br><br><br><br><br><br><br><br>•Other biochemical markers of bone metabolism<br><br><br><br><br><br><br><br>•BMD of lumbar spine, femoral neck and radius<br><br><br><br><br><br><br><br>•Adverse effects calcium or vitamin D<br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br>
- Secondary Outcome Measures
Name Time Method