Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis
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|ClinicalTrials.gov Identifier: NCT02967978|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2016
Last Update Posted : May 14, 2019
|Condition or disease|
According to the operational definition of WHO in the year 1994 osteoporosis is present if bone mineral content as assessed by DXA densitometry of the lumbar spine and/or proximal femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at least -2.5 standard deviations (DXA T-Score ≤ -2.5). This definition of osteoporosis is only valid after exclusion of other disorders, which may be associated with a reduction of bone mineral content and exclusion of osteomalacia.
By an individual screening 100 women will be included in the study who are characterized concerning existing or non-existing osteoporosis according to the guidelines of DVO 2014 and ISCD 2015, respectively.
According to the EPOS study results the prevalence of osteoporosis in Germany in postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years about 45%. In case of risk factors, such as hip fracture of father and/or mother, smoking, lactose intolerance, vegan nutrition, underweight (BMI < 20), diabetes, intake of loop diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher prevalence can be assumed. Thus by electing women with at least one risk factor of osteoporosis a higher proportion may meet the criteria of osteoporosis.
Since some women are expected to present with low vitamin D levels and so far are expected to present with osteomalacia, and since other exclusion criteria may occur, N = 100 women will be investigated, in order to obtain data from N = 80 women who may meet the criteria of the target group (about N = 40 with osteoporosis and about N = 40 without osteoporosis (normal control).
|Study Type :||Observational|
|Actual Enrollment :||130 participants|
|Official Title:||Study on the Predictive Value of the Natural Calcium Isotope Ratio in Urine and Serum for the Diagnosis of Osteoporosis|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
- calcium isotope ratio δ44/40Ca in urine [ Time Frame: 24 hours ]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.
- the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Ca urine x serum) [ Time Frame: 24 hours ]Elucidating whether the natural calcium isotope ratio δ44/40Ca in urine and serum (δ44/40Caurine x serum) differ between women with and without osteoporosis. For this purpose the δ44/40Caurine x serum of women who fulfill the criteria of osteoporosis are compared with δ44/40Caurine x serum of those who do not fulfill the criteria using Mann-Whitney tests.
- turnover rate of calcium [ Time Frame: 24 hours ]
Elucidating whether the turnover rate of calcium in the total study population assessed by the existing compartment model correlates with markers of bone formation and bone resorption (P1NP x CTX).
The level of significance will be adjusted for multiple testing.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967978
|Clinical Research Center Kiel GmbH|
|Kiel, Schleswig-Holstein, Germany, 24106|
|Principal Investigator:||Christiane Laue, Dr. med||Clinical Research Center Kiel GmbH|