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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • 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

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
Intervention / Treatment
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

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

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

National University of Singapore

Investigators

  • 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

February 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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