Status:
COMPLETED
Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
National Bank of Austria
Conditions:
Primary Hyperparathyroidism
Osteopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with primary hyperparathyroidism (pHPT) with osteopenia and osteoporosis are treated with strontium ranelate/Ca+Vitamin-D or placebo/Ca+Vitamin D after successful surgical treatment of pHPT. ...
Detailed Description
The chronic excessive hypersecretion of parathyroid hormone (PTH) has significant impact on bone remodeling. In primary hyperparathyroidism (PHPT) bone turnover is increased, resulting in a higher res...
Eligibility Criteria
Inclusion
- biochemically proven PHPT, PTX planned
- osteopenia (t-score \< -1 and \> -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria \[27\]
Exclusion
- Premenopausal women
- 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 hypocalciuric hypercalcaemia (Ca/creatinine ratio \< 0.01)
- Anamnestic pulmonal embolism or deep venous thrombosis
- Blood coagulation disorder or coagulopathy
- 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
- Known allergy against any component of the study medication
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01222026
Start Date
September 1 2010
End Date
December 1 2014
Last Update
January 21 2015
Active Locations (1)
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1
Medical University Vienna, General Hospital Vienna (AKH Wien)
Vienna, Vienna, Austria, 1090