Alterations in Muscle's Functional Characteristics After Parathyroid Surgery for Primary Hyperparathyroidism.

NCT03091140 | Completed

• 1 other identifier: 29th SesTop/31stCon/21.12.2016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol title: Alterations in functional characteristics of the muscle tissue following surgery for primary hyperparathyroidism. Purpose: To detect any changes in functional characteristics of muscles in patients who undergo surgery for primary hyperparathyroidism compared to patients with primary hyperparathyroidism and conservative treatment, patients undergoing thyroid surgery and healthy subjects. Design: Prospective, multi-center observational study Patient Population: Male or female subjects 18 years of age or older scheduled for parathyroidectomy No. of Subjects: 50 patients undergoing parathyroidectomy, 50 patients undergoing conservative follow up, 50 patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic thyroid adenoma and 50 healthy control subjects, estimated up to 12 months to enroll. Duration of Treatment: During the operation Duration of Follow-up: Follow-up will be performed daily during hospitalization and at 3, 6 and 12 months after the procedure Endpoints: To evaluate the changes in functional characteristics of all the type of muscles which occur after parathyroidectomy for primary hyperparathyroidism.

Conditions

Hyperparathyroidism, Primary; Parathyroidectomy

Keywords

Parathyroidectomy; Muscular Functional Characteristics; Parathyroid Glands

Outcome Measures

Primary Outcomes (3)

• Measuring stapedius reflex.

  Due to the fact that stapedius muscle is the smallest skeletal muscle in the human body, the investigators tend to measure stapedius reflex in order to test the hypothesis that there is association between acoustic reflex improvement and parathyroidectomy for PHPT.

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Measuring Left Ventricular Mass Index

  Cardiovascular system will be evaluated by measuring Left Ventricular Mass Index (LVMI)

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Assessing muscle strength.

  The investigators will assess muscle strength using isokinetic dynamometers

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

Secondary Outcomes (5)

• Measuring the levels of hs-CRP

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Monitoring patients' blood pressure for 24 hours.

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Neurological assessment

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Assessing quality of life

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

• Assessing physical activity

  It will be assessed before surgery and at 3, 6 and 12 months after parathyroidectomy

Study Arms (4)

Group A

patients with primary hyperparathyroidism, undergoing parathyroidectomy, as a therapeutic intervention

Group B

patients with primary hyperparathyroidism, not undergoing parathyroidectomy and receiving conservative treatment. This group will be considered as control group.

Group C

patients undergoing thyroid surgery due to nontoxic multinodular goiter or solitary nontoxic thyroid adenoma. This group will be considered as control group.

Group D

healthy subjects. This group will be considered as control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is designed as a multi-center, observational, cohort study. Any patient that has indication for a parathyroidectomy due to primary hyperparathyroidism will be considered eligible.

You may qualify if:

• Patient is over 18 years old
• Patient scheduled for a non-emergency operation
• Patients diagnosed with PHPT:
• i) one or more samples of total serum calcium above the upper limit of normal value for the laboratory (hypercalcemia) ii) serum albumin within the normal range iii) hypercalcemia with normal or elevated PTH levels iv) serum 25(OH) vitamin D more than 20 ng/ml (50nmol/lt)
• Patient eligible for parathyroid surgery: PHPT with one or more of the following i) age less than 50 years ii) serum calcium level more than 1mg/dl above the upper limit of normal iii) T score of less than -2.5 at any site, or non traumatic osteoporotic fracture by history or VFA (Vertebral Fracture Assessment) iv) history of renal colic or evidence of lithiasis/calcinosis by x-Ray or ultrasound v) creatinine clearance of less than 60ml/min vi) hypercalciuria (more than 400mg/ day)
• Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

You may not qualify if:

• Patient is participating in another clinical trial which may affect this study's outcomes
• Patient with recurrent hyperparathyroidism
• Previous operation at the thyroid and parathyroid glands or neck irradiation
• Noneuthyroid condition
• Primary hyperparathyroidism due to hyperplasia or multiple adenomas
• Secondary hyperparathyroidism
• Primary or secondary hypoparathyroidism
• Diabetes mellitus
• Chronic renal failure
• Systemic diseases (e.g. infections, neoplasms)
• Hypoalbuminemia
• Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
• Known neuromuscular disorders due to other causes
• Factors affecting acoustic reflex:
• i) Conductive or sensorineural hearing loss (hearing threshold better than 80dBs (decibells) in every testing frequency) ii) Otosclerosis iii) Middle ear dysfunction (acute or chronic inflammation) iv) Facial nerve dysfunction v) Retrocochlear damage (acoustic neurinoma, vestibular Schwannoma) vi) Impaired stapedius muscle

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University General Hospital, Aristotle University of Thessaloniki

Thessaloniki, 54621, Greece

Location

Related Publications (7)

• Farahnak P, Ring M, Caidahl K, Farnebo LO, Eriksson MJ, Nilsson IL. Cardiac function in mild primary hyperparathyroidism and the outcome after parathyroidectomy. Eur J Endocrinol. 2010 Sep;163(3):461-7. doi: 10.1530/EJE-10-0201. Epub 2010 Jun 18.

  PMID: 20562163 BACKGROUND

• Walker MD, Rundek T, Homma S, DiTullio M, Iwata S, Lee JA, Choi J, Liu R, Zhang C, McMahon DJ, Sacco RL, Silverberg SJ. Effect of parathyroidectomy on subclinical cardiovascular disease in mild primary hyperparathyroidism. Eur J Endocrinol. 2012 Aug;167(2):277-85. doi: 10.1530/EJE-12-0124. Epub 2012 Jun 1.

  PMID: 22660025 BACKGROUND

• Piovesan A, Molineri N, Casasso F, Emmolo I, Ugliengo G, Cesario F, Borretta G. Left ventricular hypertrophy in primary hyperparathyroidism. Effects of successful parathyroidectomy. Clin Endocrinol (Oxf). 1999 Mar;50(3):321-8. doi: 10.1046/j.1365-2265.1999.00651.x.

  PMID: 10435057 BACKGROUND

• Cheng SP, Liu CL, Liu TP, Hsu YC, Lee JJ. Association between parathyroid hormone levels and inflammatory markers among US adults. Mediators Inflamm. 2014;2014:709024. doi: 10.1155/2014/709024. Epub 2014 Mar 23.

  PMID: 24782595 BACKGROUND

• Almqvist EG, Bondeson AG, Bondeson L, Svensson J. Increased markers of inflammation and endothelial dysfunction in patients with mild primary hyperparathyroidism. Scand J Clin Lab Invest. 2011 Apr;71(2):139-44. doi: 10.3109/00365513.2010.543694. Epub 2010 Dec 20.

  PMID: 21166606 BACKGROUND

• Emam AA, Mousa SG, Ahmed KY, Al-Azab AA. Inflammatory biomarkers in patients with asymptomatic primary hyperparathyroidism. Med Princ Pract. 2012;21(3):249-53. doi: 10.1159/000334588. Epub 2011 Dec 16.

  PMID: 22179481 BACKGROUND

• Rolighed L, Amstrup AK, Jakobsen NF, Sikjaer T, Mosekilde L, Christiansen P, Rejnmark L. Muscle function is impaired in patients with "asymptomatic" primary hyperparathyroidism. World J Surg. 2014 Mar;38(3):549-57. doi: 10.1007/s00268-013-2273-5.

  PMID: 24101026 BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Theodossis Papavramidis, Ass. Professor

  1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, Aristotle University of Thessaloniki

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 27, 2017
• Study Start: December 25, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)