Relationship Between Homocysteine and BMD

Postmenopausal Women Clinical Trial

Official title:

Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821492
• Other study ID #: FSD-HCY-2020-05
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2021
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Diagnostic Test:
• Dual-Energy X-ray Absorptiometry (DXA)
BMD expressed in absolute values as g/cm2 and T-scores

Locations

Country	Name	City	State
Spain	Hospital Universitario Quiron Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Santiago Dexeus Font

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD expressed in absolute values as g/cm2		one year before or after Homocysteine levels
Primary	Lumbar spine T-score		one year before or after Homocysteine levels
Primary	Femoral neck T-score		one year before or after Homocysteine levels
Primary	Total hip T-score		one year before or after Homocysteine levels

External Links

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