Comparison of Calcium Metabolism in Caucasian and Asian Postmenopausal Women of Chinese Descent and the Use of Strontium as a Qualitative Marker of Calcium Metabolism

October 13, 2016 updated by: Thomas Walczyk, National University of Singapore

A Comparative Study of Calcium Metabolism in Caucasian and Asian Postmenopausal Women of Chinese Descent and the Use of Strontium as a Qualitative Marker of Calcium Metabolism in Humans

This study aims to: 1) quantitatively assess parameters of bone calcium balance in healthy postmenopausal Asian women of Chinese descent; 2) assess possible ethnic differences in calcium metabolism by direct comparison of acquired data in Chinese postmenopausal women with those acquired earlier in Caucasian postmenopausal women using the same methodology; 3) assess differences in calcium and strontium metabolism in parallel to evaluate if strontium stable isotopes can be used for tracing bone calcium metabolism qualitatively

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will follow closely the protocol that was used previously by the PI at ETH Zurich to study calcium metabolism in healthy postmenopausal women. Calcium metabolism will be studied after a single oral administration of a calcium tracer (Ca-41) and by following the excretion of the tracer in urine over 6 months. Obtained data will be used to assess parameters of calcium metabolism (flux rates and sizes of body calcium compartments) by kinetic modelling. A strontium tracer (Sr-84) will be administered in parallel and its urinary excretion pattern compared to Ca-41 excretion to determine if strontium tracers can be used to assess calcium metabolism qualitatively. Subjects will be supplemented with Vit D throughout the study. Vit D supplementation will commence 1 month before isotope administration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Investigational Medicine Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Last menstrual bleeding was at least 5 years ago.
  2. Between the ages of 50 and 75 years old.
  3. Both parents and 4 grandparents are/were of Chinese descent. It is not a necessity for the participant, participant's parents and grandparent's to be born and raised in Singapore to participate in this study.
  4. BMI above 16 and below 30

Exclusion Criteria:

  1. Diagnosed with osteoporosis
  2. Presence of significant liver disease, malignancy (excluding myeloma in the study group), malabsorption syndrome, hypoparathyroidism, hyperparathyroidism, sarcoidosis or hyperthyroidism (from toxic multinodular goitre or Graves disease), Paget's disease osteosarcoma, acromegaly, Cushing's syndrome, hypopituitarism, diabetes mellitus or severe chronic obstructive pulmonary disease.
  3. Current smoking and an alcohol intake exceeding one standard drink per day
  4. Undergoing treatment with any of the following drugs (within the last 12 months) i) adrenocorticoid steroids (3 months or longer at anytime or >10 days of treatment within the previous 12 months) ii) anticonvulsant therapy iii) pharmacological doses of thyroid hormone (causing decline of TSH below normal) iv) bisphosphonates v) calcitonin vi) synthetic parathyroid hormone vii) selective estrogen receptor modulators viii) strontium ranelate ix) estrogen therapy x ) chemotherapeutic agents xi) sodium fluoride (any history of treatment with fluoride) xii) medications known to affect calcium metabolism (diuretics, antacids, calcium channel blockers etc.).
  5. Presence of any other chronic illnesses.
  6. Any other significant medical, psychiatric and/or social issue as determined by the investigator that would compromise subject's safety and/or compliance with trial procedure.
  7. Any other clinically significant screening laboratory abnormality (as determined by the investigators).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Ca-41 & Sr-84 (isotope tracers) & vit D
Dosages: 3.7 kBq (100 nCi) Ca-41, 5 mg of Sr-84 and 400IU of vitamin D (daily)
Other: Ca-41(isotope tracer)
Ca-41 is given orally in the form of (Ca-41)Cl3 in citrate-buffered solution. Tracer will be used to determine parameters of calcium metabolism based on tracer excretion data.
Other: Sr-84 (isotope tracer)
Sr-84 is given orally in the form of (Sr-84)Cl2 in aqueous solution.Tracer will be used to determine parameters of strontium metabolism based on tracer excretion data.
Dietary supplement: Vitamin D
One tablet daily (400IU per tablet)
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time changes in urinary tracer excretion (Ca-41 and Sr-84)
Time Frame: 6 months post dose
Urine samples collected from participants are analysed for calcium and strontium content as well as Ca-41 and Sr-84 excretion.
6 months post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Flux rates and relative compartment sizes (mineralized bone, exchangeable bone calcium, plasma calcium) of the study population
Time Frame: 6 months post dose
Flux rates (mg/day) and calcium distribution between compartments (% body calcium) will be obtained by compartmental modelling of urinary tracer data. Obtained data will be compared to a mirroring study conducted earlier in Caucasian postmenopausal women.
6 months post dose
Comparison between flux rates and relative compartment sizes for calcium and strontium in each individual subject
Time Frame: 6 months post dose
Flux rates (mg/day), and calcium and strontium distribution between compartments (% body calcium and strontium ) will be obtained by compartmental modelling of urinary tracer data
6 months post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Walczyk, National University of Singapore
  • Principal Investigator: Lawrence Lee, National University Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012/01000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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