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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001703-32-AT

Enrollment

Registered

2010-08-02

Start date

2010-08-11

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia or Osteoporosis in postmenopausal women Primary hyperparathyroidism MedDRA version: 9.1 Level: LLT Classification code 10020707 Term: Hyperparathyroidism primary MedDRA version: 9.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal

Interventions

Trade Name: Protelos Pharmaceutical Form: Granules for oral suspension Pharmaceutical form of the placebo: Granules for oral suspension Route of administration of the placebo: Oral use Trade Name: MA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • postmenopausal women • biochemically proven PHPT, PTX planned • osteopenia (t-score 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

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

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: n.s.;Primary end point(s): Main outcome variables: • BMD of the lumbar spine Additional outcome variables: • Other biochemical markers of bone metabolism • BMD of the femoral neck and radius • Adverse effects of Strontium, calcium or vitamin D	—

Measure

Time frame

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. ;Secondary Objective: n.s.;Primary end point(s): Main outcome variables: • BMD of the lumbar spine Additional outcome variables: • Other biochemical markers of bone metabolism • BMD of the femoral neck and radius • Adverse effects of Strontium, calcium or vitamin D

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026