Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

Strontium ranelate/Ca + Vitamin-D helps to regain bone mass in patients with osteopenia or osteoporosis after successful parathyroidectomy for pHPT and results in higher gain of BMD than placebo treated patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborator: National Bank of Austria
• Treatments: Ergocalciferols; Strontium ranelate; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• biochemically proven PHPT, PTX planned

• osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) according to WHO Criteria [27]

Exclusion Criteria:

• 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