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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 : Unknown
Verified November 2016 by Clinical Research Center Kiel GmbH.
Recruitment status was:  Not yet recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Collaborators:
Helmholtz Centre
University of Kiel
Information provided by (Responsible Party):
Clinical Research Center Kiel GmbH

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.

Condition or disease
Osteoporosis

Detailed Description:

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
serum sample, plasma sample, urine sample, stool sample


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
100 postmenopausal women aged 50- 75y having a risk for osteoporosis should be enrolled in the study
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • known fracture within the last 3 months
  • DXA within the last 12 month before inclusion
  • Substitution with sex hormones
  • Substitution with non-identified calcium supplements
  • Vitamin D deficiency (post-hoc stratifying and exclusion from primary analysis, respectively)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967978


Contacts
Contact: Juergen Schrezenmeir, Prof. Dr. med +49 431 5606 ext 870 j.schrezenmeir@crc-kiel.de

Locations
Germany
Clinical Research Center Kiel GmbH Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24106
Contact: Laue Christiane, Dr. med    +49 431 5606-870 ext 599    c.laue@crc-kiel.de   
Sponsors and Collaborators
Clinical Research Center Kiel GmbH
Helmholtz Centre
University of Kiel
Investigators
Principal Investigator: Christiane Laue, Dr. med Clinical Research Center Kiel GmbH

Responsible Party: Clinical Research Center Kiel GmbH
ClinicalTrials.gov Identifier: NCT02967978     History of Changes
Other Study ID Numbers: GEO-Osteo-2016
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Clinical Research Center Kiel GmbH:
risk factors
Calcium isotopes
calcium turnover
DXA

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs