Relationship Between Homocysteine and BMD

NCT ID: NCT04821492

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-31

Brief Summary

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The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.

Detailed Description

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Conditions

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Postmenopausal Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hyperhomocysteinemia

Dual-Energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

BMD expressed in absolute values as g/cm2 and T-scores

Normal Hcy levels

Dual-Energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

BMD expressed in absolute values as g/cm2 and T-scores

Interventions

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Dual-Energy X-ray Absorptiometry (DXA)

BMD expressed in absolute values as g/cm2 and T-scores

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women
* BMD measured by dual-energy X-ray absorptiometry (DXA)

Exclusion Criteria

* Primary ovarian failure
* Early menopause
* Cardiovascular, liver, or renal diseases
* Surgical menopause
* History of cancer
* Receiving treatment known to influence levels of Hcy or bone mineralization (folates or vitamin B12 supplements, menopausal hormonal treatment, corticosteroids, anticonvulsants, heparin, thiazide diuretics, and antiresorptive agents).
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundación Santiago Dexeus Font

OTHER

Sponsor Role lead

Responsible Party

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Pascual García

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Quiron Dexeus

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Cagnacci A, Bagni B, Zini A, Cannoletta M, Generali M, Volpe A. Relation of folates, vitamin B12 and homocysteine to vertebral bone mineral density change in postmenopausal women. A five-year longitudinal evaluation. Bone. 2008 Feb;42(2):314-20. doi: 10.1016/j.bone.2007.10.022. Epub 2007 Nov 12.

Reference Type BACKGROUND
PMID: 18289506 (View on PubMed)

Mittal M, Verma R, Mishra A, Singh A, Kumar V, Sawlani KK, Ahmad MK, Mishra P, Gaur R. Relation of Bone Mineral Density with Homocysteine and Cathepsin K levels in Postmenopausal Women. Indian J Endocrinol Metab. 2018 Mar-Apr;22(2):261-266. doi: 10.4103/ijem.IJEM_575_17.

Reference Type BACKGROUND
PMID: 29911042 (View on PubMed)

Enneman AW, Swart KM, Zillikens MC, van Dijk SC, van Wijngaarden JP, Brouwer-Brolsma EM, Dhonukshe-Rutten RA, Hofman A, Rivadeneira F, van der Cammen TJ, Lips P, de Groot CP, Uitterlinden AG, van Meurs JB, van Schoor NM, van der Velde N. The association between plasma homocysteine levels and bone quality and bone mineral density parameters in older persons. Bone. 2014 Jun;63:141-6. doi: 10.1016/j.bone.2014.03.002. Epub 2014 Mar 12.

Reference Type BACKGROUND
PMID: 24631997 (View on PubMed)

Bahtiri E, Islami H, Rexhepi S, Qorraj-Bytyqi H, Thaci K, Thaci S, Karakulak C, Hoxha R. Relationship of homocysteine levels with lumbar spine and femur neck BMD in postmenopausal women. Acta Reumatol Port. 2015 Oct-Dec;40(4):355-62.

Reference Type BACKGROUND
PMID: 26922199 (View on PubMed)

Related Links

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http://dexeus.com

Related Info

Other Identifiers

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FSD-HCY-2020-05

Identifier Type: -

Identifier Source: org_study_id

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