Trial document





This trial has been registered retrospectively.
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  DRKS00009708

Trial Description

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Title

Effect of specific collagen peptides on bone density and serum bone markers in postmenopausal women

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Trial Acronym

FROST study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Based on the planned double-blinded placebo-controlled clinical study the influence on osteoporosis in postmenopausal women with a reduced bone density should be examined by the administration of specific collagen peptides compared to placebo. Based on the data base of previous studies it is assumed that an improvement of the bone structure is expected by the administration of the peptides. It is postulated that both a structural (increase in the organic basic structure) and a functional (inorganic mineralization) improvement of the bone tissue takes place.
On the basis of a sample size calculation, 240 postmenopausal women (80 verum with 5 g collagen peptides, 80 placebo) will participate in the placebo-controlled study. In the exploratory part of the study, 80 women are treated with 2.5 g of verum. The period is 12 months after which a significant increase in bone density meassured by DEXA (Dual Energy X-Ray Absorptiometry) is expected.
Main outcome variable is the change in bone density, which is determined by a DEXA on the proximal femur and the lumbar spine (LWS: L1-L4). Furthermore, the markers for bone reconstruction, resorption and synthesis in the blood serum are recorded.
The participants must be in the menopause (last menstruation 12 months before the start of the study) and must show a reduced bone density. In addition, no serious diseases (severe systematic diseases of the rheumatic class, malignant cancer diseases [recurrence-free for less than 5 years] or severe chronic renal disease [creatinine> 1.5 mg / dL] or liver [transaminases <2 times the norm] as well as a secondary osteoporosis with a continuance of the cause (drugs, endocrinological disorders) have to be present. Furthermore, the women must show a stable weight and nutritional behavior as well as no contraindication against a protein-rich supplementary nutrition or supplements (exactly allergy to collagen or other proteins). Women who take effective osteoporotic drugs (eg: bisphosphonates) or who have a severe osteoporosis requiring therapy do not participate in the study.
substances in the 6 months prior to study entry, cannot participate in the investigation.
After the successful control of inclusion and exclusion criteria based on a detailed medical history, a clinical examination of the knee joint and a blood test, the classification of subjects in the treatment group (collagen hydrolysate) and placebo group is made according to the random principle. According to the manufacturer, one sachet of the investigational product or similar placebos is dissolved daily in water.
During the 12-month study period 4 examination appointments will take place:
U1: Initial inspection
U2: Intermediate examination after 3 months of ingestion
U3: Intermediate examination after 6 months of ingestion
U4: Final examination of 12-month ingestion

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Brief Summary in Scientific Language

The goal of the planned double-blinded placebo-controlled clinical study is to influence osteoporosis in postmenopausal women with a reduced bone density (osteoporosis) by the oral supply of specific collagen peptides.
On the basis of data from previous studies it is assumed that by the administration of collagen peptides an improvement of the bone structure is to be expected.
Based on a sample size calculation the clinical study on 240 postmenopausal women (80 verum with 5g collagen peptides, 80 in the placebo group) over a 12 month period is conducted. In the exploratory part of the study, 80 women are treated with 2.5 g of verum. After the intervention a significant structural and functional improvement of the bone tissue is expected.
The main outcome variable is the change in the bone density, which is detected by DEXA (dual energy X-ray absorptiometry) on the proximal femur and the lumbar spine (L1-L4). Furthermore, the bone biomarkers for reconstruction, resorption and new formation in the serum are recorded

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Organizational Data

  •   DRKS00009708
  •   2016/10/13
  •   [---]*
  •   yes
  •   Approved
  •   79/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M81 -  Osteoporosis without pathological fracture
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Interventions/Observational Groups

  •   -Screening: Examination with control of the inclusion and exclusion criteria with help
    of history, DEXA, clinical examination and blood testing
    -U1: Initial examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination and monitoring of the nutritional and activity behavior followed by a 3-month intake of 5 g of collagen peptides (dissolved in water) per day
    U2: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of the anamnesis with subsequent 3-month intake of 5 g of collagen peptides (dissolved in water) per day
    U3: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination with subsequent 6-month intake of 5 g of collagen peptidse (dissolved in water) per day
    U4: Final examination after 12 months as U1 including DEXA and blood tests
  •   -Screening: Examination with control of the inclusion and exclusion criteria with help
    of history, DEXA, clinical examination and blood testing
    -U1: Initial examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination and monitoring of the nutritional and activity behavior followed by a 3-month intake of 5 g of placebo per day
    U2: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of the anamnesis with subsequent 3-month intake of 5 g of placebo per day
    U3: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination with subsequent 6-month intake of 5 g of placebo per day
    U4: Final examination after 12 months as U1 including DEXA and blood tests
  •   -Screening: Examination with control of the inclusion and exclusion criteria with help
    of history, DEXA, clinical examination and blood testing
    -U1: Initial examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination and monitoring of the nutritional and activity behavior followed by a 3-month intake of 2.5 g of collagen peptides (dissolved in water) per day
    U2: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of the anamnesis with subsequent 3-month intake of 2.5 g of collagen peptide (dissolved in water)per day
    U3: Intermediate examination with re-examination of the inclusion and exclusion criteria on the basis of anamnesis, clinical examination with subsequent 6-month intake of 2.5 g of collagen peptide (dissolved in water) per day
    U4: Final examination after 12 months as U1 including DEXA and blood tests
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Changes in the bone density (T value) after a 12-month intake of 5 g collagen peptides compared to placebo examined by DEXA (Dual Energy X-Ray Absorptiometry)

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Secondary Outcome

Secondary target variables are changes in the bone biomarker procollagen I N-terminal propeptide (P1NP) and the bone resorption marker collagen type I C-telopeptide (CTX I) in the serum after the 12-month intervention phase. The secondary target variables also include the extent to which the administration of 2.5 g collagen peptides to the bone mass (measured bey DEXA) has an effect

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/03/01
  •   240
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   45   Years
  •   80   Years
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Additional Inclusion Criteria

-Menopause (last regular bleeding 12 months ago)
Osteopenia (-2.5 ≤T value ≤ -1) or (pre-) clinical osteoporosis T value> 2.5
-no serious diseases
-stable weight and nutritional behavior
- no Contraindication against protein-rich supplementary nutrition or supplements

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Exclusion Criteria

- Effective drug therapy of osteoporosis in the last 12 months (Bisphosphonate / SERM or similar)
- severe osteoporosis requiring treatment, with impending invalidity or a high degree of fracture risk
-serve systematic disease of the rheumatic form
-allergies against collagen or other proteins
-clear secondary cause of osteoporosis with continuity of the cause (drugs, endocrinological disorders)
Malignant diseases (relapse-free< 5 years)
- Preliminary immobilization for several weeks
- Serious chronic disease (kidney [creatinine> 1.5 mg / dL], liver [transaminases> 2 times the norm)]

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Addresses

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    • Institut für Sport und Sportwissenschaft
    • Mr.  Prof. Dr.med.  Daniel  König 
    • Schwarzwaldstraße 175
    • 79117   Freiburg
    • Germany
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    • Institut für Sport und Sportwissenschaft
    • Mr.  Prof. Dr. med.  Daniel  König 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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    • Institut für Sport und Sportwissenschaft
    • Mr.  Prof. Dr. med.  Daniel  König 
    • Schwarzwaldstraße 175
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • GELITA AG
    • Uferstraße 7
    • 69412  Eberbach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.