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Calcium MetabolismNCT02565602

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

A study testing Ca-41(isotope tracer), Sr-84 (isotope tracer) and Vitamin D in people with Calcium Metabolism, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Calcium Metabolism
What is being tested?
Ca-41(isotope tracer), Sr-84 (isotope tracer) and Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSingapore
Study dates
Feb 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Last menstrual bleeding was at least 5 years ago.
  • Between the ages of 50 and 75 years old.
  • 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.
  • BMI above 16 and below 30

Who cannot join

  • Diagnosed with osteoporosis
  • 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.
  • Current smoking and an alcohol intake exceeding one standard drink per day
  • 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.).
  • Presence of any other chronic illnesses.
  • 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.
  • Any other clinically significant screening laboratory abnormality (as determined by the investigators).

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Investigational Medicine Unit

    Singapore, Singapore

Other trials in Singapore

About this study

Official 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

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

Read the 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.

Being tested
Ca-41(isotope tracer), Sr-84 (isotope tracer), Vitamin D
Keywords
Calcium metabolism, Osteoporosis, Postmenopausal women
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ca-41(isotope tracer)Other

    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.

  • Sr-84 (isotope tracer)Other

    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.

  • Vitamin DDietary supplement

    Also called Cholecalciferol

    One tablet daily (400IU per tablet)

Study groups in NCT02565602
Study groupRoleWhat they receive
Ca-41 & Sr-84 (isotope tracers) & vit DOtherDosages: 3.7 kBq (100 nCi) Ca-41, 5 mg of Sr-84 and 400IU of vitamin D (daily)
Receives: Other: Ca-41(isotope tracer); Other: Sr-84 (isotope tracer); Dietary Supplement: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time changes in urinary tracer excretion (Ca-41 and Sr-84)

    Urine samples collected from participants are analysed for calcium and strontium content as well as Ca-41 and Sr-84 excretion.

    Measured: 6 months post dose

Secondary outcomes (2)

  1. Flux rates and relative compartment sizes (mineralized bone, exchangeable bone calcium, plasma calcium) of the study population

    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.

    Measured: 6 months post dose

  2. Comparison between flux rates and relative compartment sizes for calcium and strontium in each individual subject

    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

    Measured: 6 months post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565602
Sponsor's protocol ID
2012/01000
Status last verified
Oct 2016
First submitted
21 Sep 2015
Last updated
17 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Cabrera WE, Schrooten I, De Broe ME, D'Haese PC. Strontium and bone. J Bone Miner Res. 1999 May;14(5):661-8. doi: 10.1359/jbmr.1999.14.5.661. No abstract available.

    PubMed 10320513

  • Denk E, Hillegonds D, Vogel J, Synal A, Geppert C, Wendt K, Fattinger K, Hennessy C, Berglund M, Hurrell RF, Walczyk T. Labeling the human skeleton with 41Ca to assess changes in bone calcium metabolism. Anal Bioanal Chem. 2006 Nov;386(6):1587-602. doi: 10.1007/s00216-006-0795-5. Epub 2006 Oct 11.

    PubMed 17033771

  • Denk E, Hillegonds D, Hurrell RF, Vogel J, Fattinger K, Hauselmann HJ, Kraenzlin M, Walczyk T. Evaluation of 41calcium as a new approach to assess changes in bone metabolism: effect of a bisphosphonate intervention in postmenopausal women with low bone mass. J Bone Miner Res. 2007 Oct;22(10):1518-25. doi: 10.1359/jbmr.070617.

    PubMed 17576167

  • Lee WH, Wastney ME, Jackson GS, Martin BR, Weaver CM. Interpretation of 41Ca data using compartmental modeling in post-menopausal women. Anal Bioanal Chem. 2011 Feb;399(4):1613-22. doi: 10.1007/s00216-010-4454-5. Epub 2010 Dec 9.

    PubMed 21152905

  • Lin Y, Hillegonds DJ, Gertz ER, Van Loan MD, Vogel JS. Protocol for assessing bone health in humans by tracing long-lived 41Ca isotope in urine, serum, and saliva samples. Anal Biochem. 2004 Sep 1;332(1):193-5. doi: 10.1016/j.ab.2004.05.019. No abstract available.

    PubMed 15301966

  • Suzuki T. Risk factors for osteoporosis in Asia. J Bone Miner Metab. 2001;19(3):133-41. doi: 10.1007/s007740170032. No abstract available.

    PubMed 11368297

  • Villegas R, Gao YT, Dai Q, Yang G, Cai H, Li H, Zheng W, Shu XO. Dietary calcium and magnesium intakes and the risk of type 2 diabetes: the Shanghai Women's Health Study. Am J Clin Nutr. 2009 Apr;89(4):1059-67. doi: 10.3945/ajcn.2008.27182. Epub 2009 Feb 18.

    PubMed 19225116

  • Wastney ME, Martin BR, Peacock M, Smith D, Jiang XY, Jackman LA, Weaver CM. Changes in calcium kinetics in adolescent girls induced by high calcium intake. J Clin Endocrinol Metab. 2000 Dec;85(12):4470-5. doi: 10.1210/jcem.85.12.7004.

    PubMed 11134095

  • Wu L, Martin BR, Braun MM, Wastney ME, McCabe GP, McCabe LD, DiMeglio LA, Peacock M, Weaver CM. Calcium requirements and metabolism in Chinese-American boys and girls. J Bone Miner Res. 2010 Aug;25(8):1842-9. doi: 10.1002/jbmr.76.

    PubMed 20205166

  • International Commission on Radiological Protection (1991) Biological aspects of radiological protection. Annals of the ICRP. 21, 11-25.

  • Dose coefficients for intakes of radionuclides by workers. A report of a Task Group of Committee 2 of the International Commission on Radiological Protection. Ann ICRP. 1994;24(4):1-83. No abstract available.

    PubMed 7668473

  • Schulze-König, T., Maden, C., Denk, E., Freeman, S. P. H. T., Stocker, M., Suter, M., Synal, A., Walczyk, T. (2010) Comparison of 41Ca analysis on 0.5 MV and 5 MV-AMS systems. Nuclear Instruments and Methods in Physics Research B. 268, 752-755.

Questions about this trial

What is this clinical trial studying?

A study testing Ca-41(isotope tracer), Sr-84 (isotope tracer) and Vitamin D in people with Calcium Metabolism, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time changes in urinary tracer excretion (Ca-41 and Sr-84) (time frame: 6 months post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565602, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.

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