Clincosm LogoSign in Get a demo

Effect of Mechanical Loading on vBMD and Geometry in Patients With Primary Hyperparathyroidism

Sponsor
EFSTATHIOS CHRONOPOULOS (Other)
Overall Status
Completed
CT.gov ID
NCT05426512
Collaborator
(none)
120
Enrollment
59.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

In this study we aimed to evaluate the effect of primary hyperparathyroidism (PHPT) on bone geometry simultaneously at the tibia and the radius, peripheral bone sites with similar structure but subject to different loading conditions. This evaluation was made by comparing z-scores of bone parameters measured by peripheral quantitative computed tomography (pQCT).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Postmenopausal women with primary hyperparathyroidism will be included in the study. The diagnosis of primary hyperparathyroidism is based on the high levels of parathyroid hormone and calcium.

    Postmenopausal women with kidney failure, liver failure, malabsorption syndromes, women under medication that can affect the levels of the parathyroid hormone (lithium, thiazide diuretics) and calcium levels (oestrogen, loop diuretics, denosumab, bisphosphonates), corticosteroids, and women diagnosed with familial hypocalciuric hypercalcemia will be excluded from the study.

    The control group has similar demographic characteristics and years of menopause with the patients that have primary hyperparathyroidism. Their calcium and parathyroid hormone levels are within the normal range and there is an absence of any secondary causes of osteoporosis.

    The patients' medical files will be taken from the archives of the Laboratory for research of the Musculoskeletal System 'Th.Garofalidis', Medical School, National and Kapodistrian University of Athens, KAT General Hospital of Athens. The records of these patients will be used for the recording of the total calcium levels, parathyroid hormone levels, vitamin D, creatinine, albumin, alkaline phosphatase (ALP), along with bone mineral density at the lumbar spine and femur, with the use of dual-energy x-ray absorptiometry (DEXA). Moreover, pQCT measurements of bone parameters in the region 4% (trabecular bone) and 38% (cortical bone) at the tibia and in the region 4% (trabecular bone) and 20% (cortical bone) at the radius will be recorded. pQCT bone parameters that will be recorded include total bone mineral content (tot BMC), cortical bone mineral content (cort BMC), trabecular bone mineral content (trab BMC), total bone mineral density (tot BMD), cortical bone mineral density (cort BMD), trabecular bone mineral density (trab BMD), total area (tot AREA), trabecular area (trab AREA), cortical area (cort AREA), cortical thickness (cort THICK), endocortical and periosteal circumference (enco C and peri C) and calculation of SSI.

    The primary endpoint of the study will be the comparison between the z-scores of the volumetric bone mineral density of the trabecular (trab BMD) and cortical bone (cort BMD) between the tibia and the radius. Secondary endpoints will be the differences between z-scores of the following variables in the region of the tibia and the radius. (trab BMC, cort BMC, trab AREA, cort AREA, cort THICK, endo C, peri C και SSI). Finally, the study will focus on if any differences between the z-scores are related to the severity of primary hyperparathyroidism, as it is defined by the levels of the parathyroid hormone and calcium.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Effect of Mechanical Loading on vBMD and Geometry in Patients With Primary Hyperparathyroidism
    Actual Study Start Date :
    Jan 5, 2016
    Actual Primary Completion Date :
    Dec 8, 2020
    Actual Study Completion Date :
    Dec 8, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Primary Hyperparthyroidism
    Postmenopausal women

    Outcome Measures

    Primary Outcome Measures

    1. Effect of mechanical loading on vBMD and geometry in patients with primary hyperparathyroidism [Up to 24 weeks]

      z-score for total volumetric bone mineral density (tot vBMD)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    Caucasian postmenopausal women with PHPT

    Exclusion Criteria:

    Chronic kidney disease (eGFR< 60 ml/min/1.73m2), Liver disease Malabsorption syndromes Rheumatic disease Women under medication that could affect aBMD or vBMD measurements, PTH, and /or calcium levels (lithium, thiazide/loop diuretics, estrogen, SERMS, denosumab, bisphosphonates) and corticosteroids

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • EFSTATHIOS CHRONOPOULOS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EFSTATHIOS CHRONOPOULOS, Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director, National and Kapodistrian University of Athens
    ClinicalTrials.gov Identifier:
    NCT05426512
    Other Study ID Numbers:
    • NKUAthens1
    First Posted:
    Jun 22, 2022
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hyperparathyroidism
    Hyperparathyroidism, Primary

    Study Results

    No Results Posted as of Jun 22, 2022