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Profylactic Treatment for Patients in Risk Osteoporosis (PF-Jarlsberg)

Primary Purpose

Osteopenia or Osteoporosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calsium, Vitamin D, Jarlsberg cheese
Sponsored by
Meddoc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia or Osteoporosis

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Treatment 1

    Treatment 2

    Arm Description

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

    1000 mg Calcium tablets + 20µg vitamin D

    Outcomes

    Primary Outcome Measures

    Bone Mineral Density
    g/cm2
    Bone Mineral Density
    g/cm2
    Bone Mineral Density
    g/cm2
    Bone Mineral Density
    g/cm2

    Secondary Outcome Measures

    Osteocalcin
    ng/ml
    Osteocalcin
    ng/ml
    Osteocalcin
    ng/ml
    Osteocalcin
    ng/ml
    Osteocalcin
    ng/ml
    Osteocalcin
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Procollagen type 1 N-terminal propeptide (PINP)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Cross-linked C-telopeptide type I collagen (CTX)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml
    Bone specific ALP (BALB)
    ng/ml

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 15, 2023
    Sponsor
    Meddoc
    Collaborators
    Tine, The Research Council of Norway
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05787808
    Brief Title
    Profylactic Treatment for Patients in Risk Osteoporosis
    Acronym
    PF-Jarlsberg
    Official Title
    The Effect on Bone Marker and Body Mineral Density (BMD) of Daily Jarlsberg Cheese Intake in Risk Patient for Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2025 (Anticipated)
    Study Completion Date
    December 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Meddoc
    Collaborators
    Tine, The Research Council of Norway

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Aim To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese on BMD and bone markers to patients with Osteopeni (OP). To compare daily intake of Calsium (Ca) and vitamin D with and without OED of Jarlsberg on BMD and bone markers to OP patients. To compare daily intake of Ca and vitamin D with and without OED of Jarlsberg on Time-to-Osteoporotic (TTO) treatment is recommended. 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. 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 cheese will be delivered in package of 250 gram with slices of 15.625gram. 45 gram represents 3 slices; 55 gram 4 slices. All the included patients will receive 20µg vitamin D and 1000 mg Ca. Half of the patients will receive vitamin D and Ca-tablets plus Jarlsberg cheese (Treatment group I) and other half only vitamin D and Ca-tablets (Treatment group II). Design: 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. 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. Main variables: The main response variable will be the change in Bone Mineral Density (BMD).The secondary variables will be total Osteocalcin (tOC), carboxylated osteocalcin (cOC), the osteocalcin ratio and different bone markers (BM). Additionally, the K2 vitamers MK-7, MK-8, MK-9, and MK-9(4H) will be used as explanatory variable together with the Interleukins IL-1β, IL6, IL8, IL10 and the Cytokines TNF-α, NF-ƙβ (RANK-L), OPG and TGF-β . Diet registration as controlling variables and HbA1C, Lipids, biochemical variables will be used as supporting variables. The Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) will be used for registration of Adverse Events (AE) and toxicity score at every investigation visit. Study procedure: 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 in a screening period of one week. During this screening week, all the possible participants will receive 40µg vitamin D and 500 mg Ca tablets per day, but asked not to eat Jarlsberg cheese. BMD measurements will be taken at the start of the screening week. Patients with a negative BMD T-score >-2.5 will be included in the study. All demographic data, social factors, history of disease and vital signs will be recorded at baseline. The participating patients will be given a Diet-App on the web or mobile phone for registration of the daily food intake during four first consecutively days after baseline. Blood samples for measurements of Osteocalcin, BM and vitamin K will be taken fastening in the morning. Additionally, blood samples for measuring biochemical variables, HbA1C, Lipids, Interleukins and Cytokines, will be recorded. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 used for measuring and classifying the tolerability and toxicity will be recorded as well. The patients will be given a compliance & activity form and asked to write down the daily intake of treatment medicine, Jarlsberg cheese and hours of physical activities. Clinical part: The patients will be allocated (1:1) to vitamin D + Ca-tablets ± OED of Jarlsberg cheese. All the participants will get new delivery of vitamin D and Ca-tablets every four weeks. The patients allocated to Jarlsberg will additionally receive Jarlsberg cheese. The patients will receive a compliance & activity form and asked to fill in every day. All the patients meet for new visits at week4, week 16, and week 32. Patients allocated to only vitamin D + Ca tablets at baseline well additionally meet for visits at week 20 and week 48. At all these visits blood samples for measurement of Osteocalcin, BM and PTH will be drawn fasting in the morning, and concomitant medication and treatment compliance recorded. The main visit will be performed every 16 weeks. New DXA screening will be performed. Patients obtaining a BMD T-score ≤ -2.5 will discontinue the study and switched to antiresorptive treatment plus daily OED of Jarlsberg cheese. The daily food intake during four consecutively days will be recorded on the Diet-App. Blood samples for measurements of Osteocalcin, CTX-1, PINP, BALB and PTH will be drawn fastening in the morning at every visits. Furthermore, blood samples for measuring and biochemical variables, HbA1C and Lipids, will be recorded. The CTCAE will be recorded as well.After the first 16 weeks, the patients allocated to only Ca + vitamin D will additionally receive OED of Jarlsberg cheese out the study. The visit at Week 32 and Week 48 will be the last observation for the patients initially allocated to Jarlsberg and controls, respectively. In addition to the mentioned variables, blood samples for measurement of Interleukins and Cytokines will be performed. All the patients completed the study will be offered to continue the daily intake of OED Jarlsberg cheese. These patients will be followed up one year after the last visit with a new DXA and a blood sampling for measurements of Osteocalcin level and BM. Sample size: With a significance level of 5%, a power of 90% and a Clinically Relevant Difference (CRD) of one time the Standard Deviation in change of BMD, at least 24 patients in each group must finalize the study. With an expected drop-out rate of 25%, 30 patients in each group must be included.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteopenia or Osteoporosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Masking Description
    Masking is not posible in this study
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment 1
    Arm Type
    Active Comparator
    Arm Description
    1000 mg Calcium tablets + 20µg vitamin D and optimal efficacy dose of Jarlsberg cheese
    Arm Title
    Treatment 2
    Arm Type
    Active Comparator
    Arm Description
    1000 mg Calcium tablets + 20µg vitamin D
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calsium, Vitamin D, Jarlsberg cheese
    Intervention Description
    Oral
    Primary Outcome Measure Information:
    Title
    Bone Mineral Density
    Description
    g/cm2
    Time Frame
    Week 0
    Title
    Bone Mineral Density
    Description
    g/cm2
    Time Frame
    Week 16
    Title
    Bone Mineral Density
    Description
    g/cm2
    Time Frame
    Week 32
    Title
    Bone Mineral Density
    Description
    g/cm2
    Time Frame
    Week 48
    Secondary Outcome Measure Information:
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 0
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 4
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 16
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 20
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 32
    Title
    Osteocalcin
    Description
    ng/ml
    Time Frame
    week 48
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 0
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 4
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 16
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 20
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 32
    Title
    Procollagen type 1 N-terminal propeptide (PINP)
    Description
    ng/ml
    Time Frame
    Week 48
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 0
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 4
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 16
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 20
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 32
    Title
    Cross-linked C-telopeptide type I collagen (CTX)
    Description
    ng/ml
    Time Frame
    week 48
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 0
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 4
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 16
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 20
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 32
    Title
    Bone specific ALP (BALB)
    Description
    ng/ml
    Time Frame
    Week 48
    Other Pre-specified Outcome Measures:
    Title
    Vitamin K2
    Description
    ng/ml
    Time Frame
    Week 0
    Title
    Vitamin K2
    Description
    ng/ml
    Time Frame
    Week 16
    Title
    Vitamin K2
    Description
    ng/ml
    Time Frame
    Week 32
    Title
    Vitamin K2
    Description
    ng/ml
    Time Frame
    Week 48
    Title
    Interleukin IL-1β, IL6, IL8, IL10
    Description
    ng/ml
    Time Frame
    Week 0
    Title
    Interleukin IL-1β, IL6, IL8, IL10
    Description
    ng/ml
    Time Frame
    Week 32
    Title
    Interleukin IL-1β, IL6, IL8, IL10
    Description
    ng/ml
    Time Frame
    Week 48
    Title
    Cytokine TNF-α, NF-ƙβ (RANK-L), OPG, TGF-β
    Description
    ng/ml
    Time Frame
    Week 0
    Title
    Cytokine TNF-α, NF-ƙβ (RANK-L), OPG, TGF-β
    Description
    ng/ml
    Time Frame
    Week 32
    Title
    Cytokine TNF-α, NF-ƙβ (RANK-L), OPG, TGF-β
    Description
    ng/ml
    Time Frame
    Week 48

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    Post menopausal women
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: • 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stig E Larsen, PhD
    Phone
    +47 41326325
    Email
    sl@meddoc.no
    First Name & Middle Initial & Last Name or Official Title & Degree
    Helge E Lundberg, MD
    Phone
    +47 99699619
    Email
    hl@meddoc.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne C Whist, PhD
    Organizational Affiliation
    Tine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Profylactic Treatment for Patients in Risk Osteoporosis

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