EUCTR2008-001703-32-ATActive, not recruitingPhase 1
Primary hyperparathyroidism: does a systematic treatment improve the calcium- and bone metabolism after successful surgery? – Part Systematic treatment of osteopenic and osteoporotic postmenopausal patients after successful surgical treatment for primary hyperparathyroidism with Strontium ranelate
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •postmenopausal women
- •biochemically proven PHPT, PTX planned
- •osteopenia (t-score < -1 and > 2.5) or osteoporosis (t-score = 2.5) according to WHO Criteria [27]
- •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
Exclusion Criteria
- •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)
- •Anamnestic pulmonal embolism or deep venous thrombosis
- •Blood coagulation disorder or coagulopathy
- •Phenylketonuria
- •Renal impairment (creatinine clearence <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
- •Known allergy against any component of the study medication
Investigators
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