NCT05787808: PF-Jarlsberg

Profylactic Treatment for Patients in Risk Osteoporosis

Recruiting now NA Last updated 29 September 2025

What this trial tests

NA trial testing Calsium, Vitamin D, Jarlsberg cheese in Osteopenia or Osteoporosis in 60 participants. Currently enrolling.

Timeline

2 May 2023

Primary endpoint
15 September 2025

20 October 2025

Quick facts

Lead sponsor	Meddoc
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	2 May 2023
Primary completion	15 September 2025
Estimated completion	20 October 2025
Sites	1 location across Norway

Drugs / interventions tested

• Calsium, Vitamin D, Jarlsberg cheese

Conditions studied

• Osteopenia or Osteoporosis — all drugs for Osteopenia or Osteoporosis →

Sponsor

Meddoc — full company profile →

Who can join

Adults 55 to 85, any sex, with Osteopenia or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim is to compare the daily intake of Calsium (Ca) + vitamin D with and without daily optimal efficacy dose (OED) of Jarlsberg on Bone Mineral Density (BMD) and bone markers (BM) to Osteopeni patients (OP).

* The study population consists of OP-patients of post-menopausal women and men above 55 years of age. OP patients are defined as patients with a T-score below 0.0, but larger than -2.5.
* The study will be performed as a randomized, single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and site as stratification factors. The OP-patients included in the study will be allocated to one of the two treatment groups by block randomization with random block size between 2 and 6.
* Women in post-menopausal age have a daily OED Jarlsberg of 45 gram and men in the same age interval have a daily OED of 55 gram.
* The main response variable will be the change in Bone Mineral Density (BMD),total Osteocalcin (tOC) and different bone markers (BM).
* Participants, who fulfil the inclusion criteria, do not meet any of the exclusion criteria and willing to give informed consent to participate will be included and receiving 40µg vitamin D and 500 mg Ca tablets per day, but asked not to eat Jarlsberg cheese the following week. During this week demographic data, bloodsampling for measurement of Osteocalcin and BM and diet registration will be performed.In the clinical study, all the included patients will continue with Ca+ vitamin D, but half of the patient will additionally receive daily OED of Jarlsberg cheese. After 16 weeks, all the patients will receive both Ca+vitamin D and OED of Jarlsberg for addionally 16 weeks. The total duration of the study will be 32 weeks for the patients initially allocated to Jarlsberg and 48 weeks for those allocated only to Ca+vitamin D. The patients will be investigated initially and every 16 weeks.
* A total of 30 patients will be included in each of the two groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.