Primary HPT bone marker changes after parathyroidectomy
Research type
Research Study
Full title
Primary hyperparathyroidism (HPT) bone turnover marker (BTM) changes after parathyroidectomy
IRAS ID
209925
Contact name
Anthony Skene
Contact email
Sponsor organisation
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Primary hyperparathyroidism (PHPT) is an endocrine disorder that is frequently asymptomatic and is the third most common referral to endocrinology outpatients. The increased bone turnover in PHPT is well-documented. However, the use of established and novel bone turnover markers (BTM) in assessing the bone health requires further investigation.
Surgical parathyroidectomy is the preferred choice of management for significant primary hyperparathyroidism. The procedure is associated with a significant improvement in bone outcome measures; however, the temporal relationship of change in established and novel BTM in Vitamin D replete post-parathyroidectomy patients remains unclear.
This is a pilot study with a pre-intervention post-intervention design, using routinely collected data from 100 patients who already underwent routine parathyroidectomy operation at the Royal Bournemouth Hospital. The aim of this study is to investigate the changes with time in established BTM post-parathyroidectomy, and to explore the effect of parathyroidectomy on novel bone markers.
The principle research objectives are:
• To retrospectively measure levels of the following BTM (P1NP, CTX and RANKL), using stored serum samples of patients who have already undergone surgical operation (parathyroidectomy) on their parathyroid gland; this is to establish baseline measurements for each participant before the intervention.
• To retrospectively measure the same BTM markers (post-operatively) one week following the surgical intervention.
• To retrospectively measure exploratory pre- and post-operative immunological cytokines (IL-6, TNF-α), using stored serum samples according to standard protocols.
• To correlate levels of bone turnover markers and cytokines before and after surgical intervention and 6 weeks post operatively.
• To correlate levels of these bone turnover markers with Vitamin D status and with baseline DEXA scan.Patient consent will be obtained before testing for any BTM. There will be no additional visits to the hospital for participants. Participants will be advised that they can withdraw from the study at any time without giving a reason.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0047
Date of REC Opinion
18 Jan 2018
REC opinion
Favourable Opinion