NCT05426512

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

4.9 years

First QC Date

June 10, 2022

Last Update Submit

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

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

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