Actively Recruiting

Phase Not Applicable
Age: 55Years - 85Years
All Genders
Healthy Volunteers
NCT05787808

Profylactic Treatment for Patients in Risk Osteoporosis

Led by Meddoc · Updated on 2025-09-29

60

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

M

Meddoc

Lead Sponsor

T

Tine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Profylactic Treatment for Patients in Risk Osteoporosis

Who Can Participate

Age: 55Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Osteopenia patients of both genders above 55 years old with T-score below 0.0 but above -2.5
Not Eligible

You will not qualify if you...

  • Eating disorder
  • Known gastrointestinal disorder
  • Abnormal liver or kidney function
  • Type I diabetes mellitus
  • Type II diabetes without sufficient control
  • Verified cancer
  • Treatment with corticosteroids or immunosuppressive drugs in last 3 weeks
  • Active antiresorptive or anabolic treatment
  • Participation in another drug trial in last 6 weeks
  • Known allergy to milk products
  • Unable to understand study information
  • Unwilling or unable to give written consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Meddoc

Skjetten, Akershus, Norway, 2013

Actively Recruiting

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Research Team

S

Stig E Larsen, PhD

CONTACT

H

Helge E Lundberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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