Clinical trial NCT04821492: Relationship Between Homocysteine and BMD
Official title: Evaluation of the Relationship Between Homocysteine Levels and Bone Mineral Density in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Women
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 760
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women visited at the Obstetrics and Gynecology Department at the Hospital Universitario Dexeus (Barcelona, Spain).

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: BMD expressed in absolute values as g/cm2
timeFrame: one year before or after Homocysteine levels
measure: Lumbar spine T-score
timeFrame: one year before or after Homocysteine levels
measure: Femoral neck T-score
timeFrame: one year before or after Homocysteine levels
measure: Total hip T-score
timeFrame: one year before or after Homocysteine levels
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron Dexeus
Study officials:
References:
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.
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.
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.
citation: 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.