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Phase 3 Completed N=46 Randomized Quadruple-blind Treatment

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Source: ClinicalTrials.gov NCT00674154 ↗
Enrolled (actual)
46
Serious AEs
4.8%
Results posted
Oct 2013
Primary outcomePrimary: Decrease in Preoperative P-PTH — -2.2; 0.2 pmol/l

Summary

The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Outcome Measures

OutcomeResultp-value
PRIMARY
Decrease in Preoperative P-PTH
-2.2; 0.2 —
SECONDARY
Improved Muscular Function
— —
SECONDARY
Reduced Postoperative Hypocalcemia
— —
SECONDARY
Increase in Quality of Life
— —
SECONDARY
Increased Bone Mineral Density
— —
SECONDARY
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
— —

Eligibility Criteria

Inclusion Criteria

  • P-Ca-ion > 1,30 mmol/l
  • P-PTH > 5 pmol/l
  • P-OH25-vitamin D 120 mumol/l
  • usage of Etalpha, Mimpara
  • Cancer
  • Sarcoidosis
  • malabsorption
  • pancreatitis
  • alcohol abuse
  • pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00674154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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