NCT02565602

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

September 21, 2015

Last Update Submit

October 13, 2016

Conditions

Calcium Metabolism

Keywords

Calcium metabolismOsteoporosisPostmenopausal women

Outcome Measures

Primary Outcomes (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.

    6 months post dose

Secondary Outcomes (2)

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

    6 months post dose

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

    6 months post dose

Study Arms (1)

Ca-41 & Sr-84 (isotope tracers) & vit D

OTHER

Dosages: 3.7 kBq (100 nCi) Ca-41, 5 mg of Sr-84 and 400IU of vitamin D (daily)

Other: Ca-41(isotope tracer)Other: Sr-84 (isotope tracer)Dietary Supplement: Vitamin D

Interventions

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.

Ca-41 & Sr-84 (isotope tracers) & vit D
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.

Ca-41 & Sr-84 (isotope tracers) & vit D
Vitamin DDIETARY_SUPPLEMENT

One tablet daily (400IU per tablet)

Also known as: Cholecalciferol
Ca-41 & Sr-84 (isotope tracers) & vit D

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Medicine Unit

Singapore, Singapore, Singapore

Location

Related Publications (12)

  • 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.

    PMID: 10320513BACKGROUND

  • 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.

    PMID: 17033771BACKGROUND

  • 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.

    PMID: 17576167BACKGROUND

  • 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.

    PMID: 21152905BACKGROUND

  • 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.

    PMID: 15301966BACKGROUND

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

    PMID: 11368297BACKGROUND

  • 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.

    PMID: 19225116BACKGROUND

  • 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.

    PMID: 11134095BACKGROUND

  • 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.

    PMID: 20205166BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 7668473BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Thomas Walczyk

    National University of Singapore

    PRINCIPAL INVESTIGATOR

  • Lawrence Lee

    National University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

October 1, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

SG(1)