Primary hyperparathyroidism: does a systematic treatment improve the calcium and bone metabolism after successful surgery? – Part II Systematic treatment of patients with neither osteopenia nor osteoporosis after successful surgical treatment for primary hyperparathyroidism with Calcium and Vitamin D

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001704-23-AT

Enrollment

Registered

2009-08-18

Start date

2009-09-03

Completion date

Unknown

Last updated

2018-09-24

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

Conditions

Hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection). MedDRA version: 9.1 Level: LLT Classification code 10020707 Term: Hyperparathyroidism primary

Interventions

Trade Name: MAXI-KALZ Vit.D3 500mg/400 I.E. - Kautabletten Pharmaceutical Form: Chewable tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • postmenopausal women • male patients • biochemically proven PHPT, PTX planned • no evidence for osteoporosis or osteopenia (normal BMD) 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) • Phenylketonuria • Renal impairment (creatinine clearence <30ml/h) • Severe hepatic disorder • Severe systemic disorder • Thyroid dysfunction • Concomittant thyroid surgery • 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 • Intake of drugs containing digoxin or digitoxin • Known allergy against any component of the study medication

Design outcomes

Primary

Measure	Time frame
Main Objective: Does calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection)?;Secondary Objective: ;Primary end point(s): Main outcome variables: • PTH Additional outcome variables: • Other biochemical markers of bone metabolism • BMD of lumbar spine, femoral neck and radius • Adverse effects calcium or vitamin D	—

Measure

Time frame

Main Objective: Does calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection)?;Secondary Objective: ;Primary end point(s): Main outcome variables: • PTH Additional outcome variables: • Other biochemical markers of bone metabolism • BMD of lumbar spine, femoral neck and radius • Adverse effects 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