Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358443
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-05
Brief Title:
The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia
Sponsor:
Meddoc
Organization:
Meddoc
Study Overview
Official Title:
The Long-term Effect on Bone Markers BM and Body Mineral Density BMD of Daily Jarlsberg Cheese Intake in Patient With Osteopenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PF-JB3
Brief Summary:
Aim To estimate the effect of daily optimal efficacy dose OED of Jarlsberg cheese in patients with Osteopeni OP
Study population Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment Daily OED Jarlsberg cheese vitamin D and Calcium tablets Design An open and one-armed observational study Main variables Bone Mineral Density BMD Bone turnover markers BTMs Osteocalcin and K2 vitameres
Study Procedure Prior to inclusion in this study all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese vitamin D and caicium tablets Thid is the baseline of this observational study The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months
Sample size At least 16 patients will be included
Study population Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment Daily OED Jarlsberg cheese vitamin D and Calcium tablets Design An open and one-armed observational study Main variables Bone Mineral Density BMD Bone turnover markers BTMs Osteocalcin and K2 vitameres
Study Procedure Prior to inclusion in this study all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese vitamin D and caicium tablets Thid is the baseline of this observational study The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months
Sample size At least 16 patients will be included
Detailed Description:
Aim To estimate the short- and long-term effect of daily optimal efficacy dose OED of Jarlsberg cheese on BMD bone turn-over markers BTMs and Osteocalcin in patients with Osteopeni OP
Study population The study population consists of OP-patients of post-menopausal women and men above 55 years of age who had a daily OED intake of Jarlsberg Cheese 32 weeks prior to inclusion in the study OP patients are defined as patients with a T-score below 00 but larger than -25
Trial treatment The optimal daily intake of Jarlsberg cheese depending on gender age and physical activity Women in post-menopausal age have a daily OED Jarlsberg of 47gram and men in above 55 years of age have an estimated daily OED of 71gramThe cheese will be delivered in package of 250 gram with slices average of 15625gram 47 gram represents 3 slices and 67 gram 45 slices In addition to Jarlsberg Cheese all the included patients will receive 40mcg vitamin D and 500 mg Ca
Design The study will be performed as a follow-up study of a randomized single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and participating General Practitioner GP site as stratification factors GPs from Viken county will participate This follow-up part will be performed as an open and one-armed observational study
Main variables The main response variable will be the change in Bone Mineral Density BMD and recorded at baseline follow-up after 32 weeks with daily Jarlsberg intake and the end of the follow-up study Week 52 The second main variables will be total Osteocalcin tOC carboxylated osteocalcin cOC the osteocalcin ratio RO defined as the ratio between cOC and under-carboxylated osteocalcin ucOC RO cOC ucOC recorded at baseline-FU week 26 and week 52 Additionally the bone turnover markers BTMs cross-linked C-telopeptide type I collagen CTX procollagen type 1 N-terminal propeptide PINP bone specific ALP BALB and Parathyroid hormone PTH will be measured at the same visits At baseline-FU and week 52 the following variables will be measured Vitamin K2 and the different vitamers MK-7 MK-8 MK-9 and MK-94H used as explanatory variable Diet registration as controlling variables and HbA1C Lipids biochemical variables together with Quality-of-Life QoL questionnaire as supporting variables The Interleukins IL-1β IL6 IL8 IL10 and the Cytokines TNF-α NF-ƙβ RANK-L OPG and TGF-β will be measured at baseline-FU and at the last visit in the study Week 52 The Common Terminology Criteria for Adverse Events version 40 CTCAE will be used for registration of Adverse Events AE and toxicity score at all investigation visits
Study procedure
Baseline of Follow-up Patients who completed 32 weeks of daily intake of Jarlsberg OED in the PF-JarlsbergIIIA and willing to give informed consent to participate in the follow-up part will be included The baseline for the follow-up part will be the last control in the PF-JarlsbergIIIA This includes measurements of BMD Osteocalcin CTX-1 PINP BALP PTH and vitamin K Additionally blood samples for measuring of the central biochemical variables and registration of the food intake during four consecutive days will be performed The Common Terminology Criteria for Adverse Events CTCAE version 40 used for measuring and classifying the tolerability and toxicity will be recorded as well The included patients will receive Jarlsberg Cheese vitamin D- and Ca tablets as in the previous study for eight weeks The daily intake of Jarlsberg will be 47gram for women and 71gram for men combined with 40μg vitamin D and 500 mg Ca The patients will be given a Compliance Activity form CAF and asked to write down the daily intake of treatment medicine Jarlsberg cheese and hours of physical activities
Clinical part All the participants will get a new delivery Jarlsberg Cheese vitamin D and Ca-tablets every eight weeks The patients will return the CAF for the previous period and receive a new CAF to fill in every day during the next eight-week period After 26 weeks in the Follow-up the patients meet for a new visit at the Medical Centre At this visit a physical examination will be performed blood samples for measurement of Osteocalcin CTX-1 PINP BALP PTH and the central biochemical variables will be taken concomitant medication and treatment compliance recorded
The participating patients will receive Jarlsberg vitamin and Ca-tablets at week 816 24 32 40 and 48 The final visit and physical examination in the Follow-up study will be performed at week 52 This includes measurements of BMD Osteocalcin BTMs and vitamin K Additionally blood samples for measuring lipides HbA1C and the central biochemical variables and registration of the daily food intake during four consecutive days will be performed The Common Terminology Criteria for Adverse Events CTCAE version 40 used for measuring and classifying the tolerability and toxicity will be recorded as well
Sample size The change from baseline FU to week 52 in BMD expressed by the 95 Confidence Interval of the change must be SD in change of BMD at least 16 patients in each gender group must finalize the study
Study population The study population consists of OP-patients of post-menopausal women and men above 55 years of age who had a daily OED intake of Jarlsberg Cheese 32 weeks prior to inclusion in the study OP patients are defined as patients with a T-score below 00 but larger than -25
Trial treatment The optimal daily intake of Jarlsberg cheese depending on gender age and physical activity Women in post-menopausal age have a daily OED Jarlsberg of 47gram and men in above 55 years of age have an estimated daily OED of 71gramThe cheese will be delivered in package of 250 gram with slices average of 15625gram 47 gram represents 3 slices and 67 gram 45 slices In addition to Jarlsberg Cheese all the included patients will receive 40mcg vitamin D and 500 mg Ca
Design The study will be performed as a follow-up study of a randomized single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and participating General Practitioner GP site as stratification factors GPs from Viken county will participate This follow-up part will be performed as an open and one-armed observational study
Main variables The main response variable will be the change in Bone Mineral Density BMD and recorded at baseline follow-up after 32 weeks with daily Jarlsberg intake and the end of the follow-up study Week 52 The second main variables will be total Osteocalcin tOC carboxylated osteocalcin cOC the osteocalcin ratio RO defined as the ratio between cOC and under-carboxylated osteocalcin ucOC RO cOC ucOC recorded at baseline-FU week 26 and week 52 Additionally the bone turnover markers BTMs cross-linked C-telopeptide type I collagen CTX procollagen type 1 N-terminal propeptide PINP bone specific ALP BALB and Parathyroid hormone PTH will be measured at the same visits At baseline-FU and week 52 the following variables will be measured Vitamin K2 and the different vitamers MK-7 MK-8 MK-9 and MK-94H used as explanatory variable Diet registration as controlling variables and HbA1C Lipids biochemical variables together with Quality-of-Life QoL questionnaire as supporting variables The Interleukins IL-1β IL6 IL8 IL10 and the Cytokines TNF-α NF-ƙβ RANK-L OPG and TGF-β will be measured at baseline-FU and at the last visit in the study Week 52 The Common Terminology Criteria for Adverse Events version 40 CTCAE will be used for registration of Adverse Events AE and toxicity score at all investigation visits
Study procedure
Baseline of Follow-up Patients who completed 32 weeks of daily intake of Jarlsberg OED in the PF-JarlsbergIIIA and willing to give informed consent to participate in the follow-up part will be included The baseline for the follow-up part will be the last control in the PF-JarlsbergIIIA This includes measurements of BMD Osteocalcin CTX-1 PINP BALP PTH and vitamin K Additionally blood samples for measuring of the central biochemical variables and registration of the food intake during four consecutive days will be performed The Common Terminology Criteria for Adverse Events CTCAE version 40 used for measuring and classifying the tolerability and toxicity will be recorded as well The included patients will receive Jarlsberg Cheese vitamin D- and Ca tablets as in the previous study for eight weeks The daily intake of Jarlsberg will be 47gram for women and 71gram for men combined with 40μg vitamin D and 500 mg Ca The patients will be given a Compliance Activity form CAF and asked to write down the daily intake of treatment medicine Jarlsberg cheese and hours of physical activities
Clinical part All the participants will get a new delivery Jarlsberg Cheese vitamin D and Ca-tablets every eight weeks The patients will return the CAF for the previous period and receive a new CAF to fill in every day during the next eight-week period After 26 weeks in the Follow-up the patients meet for a new visit at the Medical Centre At this visit a physical examination will be performed blood samples for measurement of Osteocalcin CTX-1 PINP BALP PTH and the central biochemical variables will be taken concomitant medication and treatment compliance recorded
The participating patients will receive Jarlsberg vitamin and Ca-tablets at week 816 24 32 40 and 48 The final visit and physical examination in the Follow-up study will be performed at week 52 This includes measurements of BMD Osteocalcin BTMs and vitamin K Additionally blood samples for measuring lipides HbA1C and the central biochemical variables and registration of the daily food intake during four consecutive days will be performed The Common Terminology Criteria for Adverse Events CTCAE version 40 used for measuring and classifying the tolerability and toxicity will be recorded as well
Sample size The change from baseline FU to week 52 in BMD expressed by the 95 Confidence Interval of the change must be SD in change of BMD at least 16 patients in each gender group must finalize the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None