Profylactic Treatment for Patients in Risk Osteoporosis

NCT05787808 | Recruiting DMC

• 2 other identifiers: PF-Jarlsberg/IIIA2022-003252-13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Osteopenia or Osteoporosis

Outcome Measures

Primary Outcomes (4)

• Bone Mineral Density

  g/cm2

  Week 0

• Bone Mineral Density

  g/cm2

  Week 16

• Bone Mineral Density

  g/cm2

  Week 32

• Bone Mineral Density

  g/cm2

  Week 48

Secondary Outcomes (24)

• Osteocalcin

  week 0

• Osteocalcin

  week 4

• Osteocalcin

  week 16

• Osteocalcin

  week 20

• Osteocalcin

  week 32

Other Outcomes (10)

• Vitamin K2

  Week 0

• Vitamin K2

  Week 16

• Vitamin K2

  Week 32

Study Arms (2)

Treatment 1

ACTIVE COMPARATOR

1000 mg Calcium tablets + 20µg vitamin D and optimal efficacy dose of Jarlsberg cheese

Dietary Supplement: Calsium, Vitamin D, Jarlsberg cheese

Treatment 2

ACTIVE COMPARATOR

1000 mg Calcium tablets + 20µg vitamin D

Dietary Supplement: Calsium, Vitamin D, Jarlsberg cheese

Interventions

Calsium, Vitamin D, Jarlsberg cheese DIETARY_SUPPLEMENT

Oral

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 55 Years - 85 Years
• Gender Eligibility Details: Post menopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteopeni patients (OP) of both genders above 55 years of age. OPs are defined as patients with T-score below 0.0 but larger than -2.5.

You may not qualify if:

• Eating disorder
• Known gastrointestinal disorder.
• Abnormal liver or kidney function.
• Diabetes mellitus type I.
• Diabetes type II without sufficient control.
• Suffering from verified cancer.
• Under systemic treatment with corticosteroids or other immunosuppressive drugs the last 3 weeks before start of the trial treatment.
• Under active antiresorptive treatment or anabolic treatment.
• Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment.
• Known milk product allergy.
• Not able to understand information.
• Do not want or not able to give written consent to participate in the study.

Sponsors & Collaborators

• Meddoc: lead
• Tine: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

Meddoc

Skjetten, Akershus, 2013, Norway

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anne C Whist, PhD

  Tine

  STUDY DIRECTOR

Central Study Contacts

Stig E Larsen, PhD

CONTACT

+47 41326325; sl@meddoc.no

Helge E Lundberg, MD

CONTACT

+47 99699619; hl@meddoc.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not posible in this study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Model Details: The patients are randomised (1:1) into to parallel groups and followed up in 16 weeks. All the patients are switched to the same treatment for the following 16 weeks

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: May 2, 2023
• Primary Completion: September 15, 2025
• Study Completion: October 20, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)