Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis
1 other identifier
observational
130
1 country
1
Brief Summary
The study aims at investigating whether the natural calcium isotope ratio (δ44/40Ca) in urine and serum differs between postmenopausal women aged 50 to 75 years suffering from osteoporosis and a healthy control group and whether δ44/40Ca in urine and serum can be used for the diagnosis of osteoporosis or whether further parameters have to be included.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedStudy Start
First participant enrolled
November 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedFebruary 9, 2021
February 1, 2021
3 months
November 16, 2016
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
calcium isotope ratio δ44/40Ca in urine
δ44/40Ca in urine of postmenopausal women who fulfill the criteria of osteoporosis are compared with δ44/40Ca in urine of those who do not fulfill the criteria using Mann-Whitney tests.
24 hours
Secondary Outcomes (2)
the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Ca urine x serum)
24 hours
turnover rate of calcium
24 hours
Eligibility Criteria
100 postmenopausal women aged 50- 75y having a risk for osteoporosis should be enrolled in the study
You may qualify if:
- Postmenopausal women
- Age 50 - 75 years
- Fullfilling the criteria for diagnostic examination for osteoporosis incl. DXA according to DVO/ZÄS list 2015
- Written informed consent
You may not qualify if:
- known fracture within the last 3 months
- Substitution with sex hormones
- Substitution with non-identified calcium supplements
- Hyperparathyreoidism (by history and based on calcium, phosphate and chloride in serum
- known renal failure
- known cancer disease
- Current enrollement in a clinical intervention trial
- Enrollement in a clinical intervention trial within the last 4 weeks
- Severe cognitive or psychiatric disorder
- Scheduled hospitalisation before the radiological examination (DXA)
- Legal incapacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinical Research Center Kiel GmbHlead
- University of Kielcollaborator
Study Sites (1)
Clinical Research Center Kiel GmbH
Kiel, Schleswig-Holstein, 24106, Germany
Biospecimen
serum sample, plasma sample, urine sample, stool sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane Laue, Dr. med
Clinical Research Center Kiel GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med (medical doctor)
Study Record Dates
First Submitted
November 16, 2016
First Posted
November 18, 2016
Study Start
November 22, 2016
Primary Completion
March 3, 2017
Study Completion
August 16, 2019
Last Updated
February 9, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share