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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02565602
• Date of registration: 21/09/2015
• Prospective Registration: No
• Primary sponsor: National University, Singapore
• Public title: 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
• Scientific title: 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
• Date of first enrolment: February 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02565602
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Thomas Walczyk
• Affiliation: National University, Singapore

• Name: Lawrence Lee
• Affiliation: National University Health System

Key inclusion & exclusion criteria

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).



Age minimum: 50 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Calcium Metabolism

Intervention(s)

Dietary Supplement: Vitamin D

Other: Sr-84 (isotope tracer)

Other: Ca-41(isotope tracer)

Primary Outcome(s)

Time changes in urinary tracer excretion (Ca-41 and Sr-84) [Time Frame: 6 months post dose]

Secondary Outcome(s)

Flux rates and relative compartment sizes (mineralized bone, exchangeable bone calcium, plasma calcium) of the study population [Time Frame: 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]

Secondary ID(s)

2012/01000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors