Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06358443 |
| Other study ID # |
PF-Jarlsberg/IIIB |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2024 |
| Est. completion date |
February 23, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Meddoc |
| Contact |
Stig Larsen, PhD |
| Phone |
+47 41326325 |
| Email |
sl[@]meddoc.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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 0.0 but
larger than -2.5.
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 71gram.The cheese will be delivered
in package of 250 gram with slices average of 15.625gram. 47 gram represents 3 slices and 67
gram 4.5 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. GP's 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-9(4H) 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 4.0 (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-Jarlsberg/IIIA 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-Jarlsberg/IIIA. 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 4.0 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 8,16, 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 4.0 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.
