Effect of Mechanical Loading on vBMD and Geometry in Patients With Primary Hyperparathyroidism
1 other identifier
observational
120
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2020
CompletedFirst Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedJune 22, 2022
June 1, 2022
4.9 years
June 10, 2022
June 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of mechanical loading on vBMD and geometry in patients with primary hyperparathyroidism
z-score for total volumetric bone mineral density (tot vBMD)
Up to 24 weeks
Study Arms (2)
Primary Hyperparthyroidism
Postmenopausal women
Eligibility Criteria
Caucasian postmenopausal women with PHPT and healthy Caucasian postmenopausal women
You may qualify if:
- Caucasian postmenopausal women with PHPT
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Karlafti E, Dontas I, Lambrinoudaki I, Vlamis I, Lampropoulou-Adamidou K, Makris K, Trifonidi I, Galanos A, Trovas G, Chronopoulos E, Tournis S. Site specific differences in vBMD and geometry in postmenopausal women with primary hyperparathyroidism. Endocrine. 2024 Jan;83(1):205-213. doi: 10.1007/s12020-023-03491-8. Epub 2023 Aug 19.
PMID: 37597095DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor in Orthopaedics at National and Kapodistrian University of Athens, Laboratory for Research of the Musculoskeletal System Director
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 22, 2022
Study Start
January 5, 2016
Primary Completion
December 8, 2020
Study Completion
December 8, 2020
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share