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RecruitingNCT04265599Updated Oct 1, 2024

Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil

An observational study in Hypercalcemia, Renal Injury and Paraffinoma, sponsored by Herlev Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Herlev Hospital · Observational

From the registry’s dates

  • Started Apr 2019; still recruiting 7 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.

02

Conditions studied

  • Hypercalcemia
  • Renal Injury
  • Paraffinoma

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03

In context

Hypercalcemia

51 studies on the registry are indexed under Hypercalcemia; 9 are open to participants now.

This study's planned enrollment of 200 is close to the median of 193 across 14 observational studies indexed under Hypercalcemia.

Browse Hypercalcemia studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.

Browse Herlev Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

General population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • previous intramuscular injection of paraffin or other oil

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia

    Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.

    Time frame: at first examination or developed during observation period until 2025

  2. Number of patients with concentration of parathyroid hormone PTH in plasma below normal range

    PTH level in plasma indicator of hypercalcemia

    Time frame: at first examination or developed during observation period until 2025

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2019 (actual). Primary completion is estimated for Jan 2027, 93 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2020
First posted
Feb 11, 2020
StartActual
Apr 30, 2019
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Oct 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04265599
Lead sponsor
Herlev Hospital
Responsible party
Ebbe Eldrup, MD, DMSc (Principal investigator Consultant Endocrinologist MD DMSc, Herlev Hospital) — Principal investigator
First posted
Feb 11, 2020
Start date
Apr 30, 2019
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 1, 2024

Study contacts

Ebbe Eldrup, DMSc
Contact
ebbe.eldrup@regionh.dk
800-045-3868
Martin Blomberg Jensen, DMSc
Contact
blombergjensen@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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