Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05426512
Other study ID # NKUAthens1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2016
Est. completion date December 8, 2020

Study information

Verified date June 2022
Source National and Kapodistrian University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
EFSTATHIOS CHRONOPOULOS

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Completed NCT04305561 - Preoperative Localization Strategies in Primary Hyperparathyroidism N/A
Recruiting NCT03052075 - Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Completed NCT03774771 - Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism Phase 2
Recruiting NCT02854345 - Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera N/A
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Recruiting NCT00973336 - Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery? Phase 2
Completed NCT01530919 - Minimally Invasive Radioguided Parathyroidectomy N/A
Recruiting NCT03605472 - Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism N/A
Completed NCT01306656 - Vitamin D Repletion in Primary Hyperparathyroidism Phase 4
Terminated NCT00961701 - Lipids Profile in Primary Hyperparathyroidism N/A
Completed NCT00432939 - Primary Hyperparathyroidism: Non-classical Manifestations N/A
Completed NCT00522028 - Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial N/A
Completed NCT03713671 - Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism N/A
Recruiting NCT04969926 - Natural History Study of Parathyroid Disorders
Recruiting NCT03039439 - Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
Not yet recruiting NCT03732157 - Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
Completed NCT01996072 - EC17 for Intraoperative Imaging for Parathyroidectomy Phase 1
Completed NCT01460030 - An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism Phase 3
Enrolling by invitation NCT04085419 - Osteoporosis in Primary Hyperparathyroidism Phase 4