Status:
UNKNOWN
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?
Lead Sponsor:
Medical University of Vienna
Conditions:
Primary Hyperparathyroidism
Bone Metabolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Postmenopausal women
- Male patients
- Biochemically proven PHPT, PTX planned
- No evidence for osteoporosis
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00973336
Start Date
September 1 2009
End Date
September 1 2017
Last Update
March 16 2016
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090