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

Phase 1

Conditions: Osteopenia or Osteoporosis in postmenopausal womenPrimary hyperparathyroidism
MedDRA version: 9.1Level: LLTClassification code 10020707Term: Hyperparathyroidism primary
MedDRA version: 9.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausal

Registration Number: EUCTR2008-001703-32-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 60

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of Strontium ranelate and Calcium/Vitamin D on bone density and metabolism in patients after surgical cure of primary hyperparathyroidism.<br><br>;Secondary Objective: n.s.;Primary end point(s): Main outcome variables:<br><br>•BMD of the lumbar spine<br><br><br><br>Additional outcome variables:<br><br>•Other biochemical markers of bone metabolism<br><br>•BMD of the femoral neck and radius<br><br>•Adverse effects of Strontium, calcium or vitamin D<br><br><br><br>

Secondary Outcome Measures