Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Successful Surgery in Patients Without Osteoporosis?
Overview
- Phase
- Phase 2
- Intervention
- Calcium and vitamin D
- Conditions
- Primary Hyperparathyroidism
- Sponsor
- Medical University of Vienna
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Parathyroid hormone
- Last Updated
- 10 years ago
Overview
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).
Investigators
Philipp Riss
Assistent Professor
Medical University of Vienna
Eligibility Criteria
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
Arms & Interventions
Calcium and vitamin D
Intervention
Intervention: Calcium and vitamin D
Outcomes
Primary Outcomes
Parathyroid hormone
Time Frame: 1 year
Secondary Outcomes
- 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)