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Trial registered on ANZCTR


Registration number
ACTRN12620000826943
Ethics application status
Approved
Date submitted
22/11/2019
Date registered
18/08/2020
Date last updated
18/08/2020
Date data sharing statement initially provided
18/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Parathyroidectomy on Frail Older Persons
Scientific title
Effect of Parathyroidectomy on Frailty in Older Persons
Secondary ID [1] 299885 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Frailty 315303 0
Hyperparathyroidism 315304 0
Condition category
Condition code
Musculoskeletal 313603 313603 0 0
Osteoporosis
Metabolic and Endocrine 313604 313604 0 0
Other metabolic disorders
Surgery 313605 313605 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery - Parathyroidectomy . The cases will undergo parathyroidectomy within a month of the first review for the study. Parathyroidectomy is the procedure involving surgical removal of one or more of the parathyroid glands. The procedure can be done under general anaesthesia or local anaesthesia. The incision is usually made just under the larynx and the oofending glads are located. The duration of the surgery depends o the complexity and could range from 30 minutes if straightforward versus hours if there are any complications. Minimally invasive procedures are becoming increasingly popular.
Intervention code [1] 316152 0
Treatment: Surgery
Comparator / control treatment
Elderly persons undergoing Thyroidectomy. The controls will undergo thyroidectomy for benign conditions within a month of the first review.
Thyroidectomy is the operation done for partial or complete removal of the thyroid gland through a incision in the neck. The surgery usually takes one to two hours and depends o the complexity of the individual case. During the entire surgery, the surgeon will pay attention to note the locate the parathyroid glands and aim to conserve them.
Control group
Active

Outcomes
Primary outcome [1] 322054 0
Frailty
The method of assessment will be using the Frailty criteria including the Fried's criteria and Rockwood's frailty criteria
Participants will be classified as fit, pre-frail and frail based on Fried’s criteria
-Gait velocity - Gait is evaluated using a sensitive walkway (GAITRite®, 16’
model, CIR Systems Inc, Havertown, PA). Software records the spatiotemporal
gait over 4.8m with participants walking at their usual pace.
Parameters assessed include stride and step length (cm), single and
double limb support (%), and gait cadence.
-Grip strength - this is assessed my measuring hand grip strength using a hand held dynamometer.
- Weight loss - self reported weight loss of >4.5kg or recorded weight loss > 5% per annum
Timepoint [1] 322054 0
Three months post surgery
Primary outcome [2] 324515 0
Functional parameters
Assessed using the activity of daily living index by Oars
Timepoint [2] 324515 0
3 months post surgery
Primary outcome [3] 324516 0
Bone mineral density and muscle mass measured using our DXA scan
Timepoint [3] 324516 0
3 months post surgery
Secondary outcome [1] 377158 0
Cognition
Assessed using modified Mini Mental Status examination
Timepoint [1] 377158 0
3 months post surgery

Eligibility
Key inclusion criteria
Women (60 years and older) undergoing neck exploration for pHPT
Women of the same age undergoing neck exploration for benign nontoxic goiter will serve as controls.
Minimum age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
malignant/toxic goitres; males ; age<60yrs

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 15284 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 15285 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 28594 0
3021 - St Albans
Recruitment postcode(s) [2] 28595 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 304342 0
University
Name [1] 304342 0
AIMSS- University of Melbourne
Address [1] 304342 0
Western Health/ AIMSS- , Level 3 WCHRE, Sunshine Hospital ,176 Furlong Road, St Albans, VIC, 3021, Australia
Country [1] 304342 0
Australia
Primary sponsor type
University
Name
AIMSS - University of Melbourne
Address
AIMSS- , Level 3 WCHRE, Sunshine Hospital ,176 Furlong Road, St Albans, VIC, 3021, Australia
Country
Australia
Secondary sponsor category [1] 304593 0
University
Name [1] 304593 0
University of Sydney
Address [1] 304593 0
Nepean Clinical School, 62 Derby Street, Kingswood, NSW 2747
Country [1] 304593 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304794 0
HREC - NBMLHD
Ethics committee address [1] 304794 0
NBMLHD - HREC
Level 5, South Block
Nepean Hospital
Kingswood NSW 2747
Ethics committee country [1] 304794 0
Australia
Date submitted for ethics approval [1] 304794 0
13/04/2015
Approval date [1] 304794 0
30/11/2015
Ethics approval number [1] 304794 0
HREC/15/NEPEAN/71

Summary
Brief summary
This case-control study aims to identify whether correcting serum parathyroid hormone (PTH) after parathyroidectomy would have an effect on the clinical criteria for frailty, which are highly prevalent in older persons suffering from primary hyperparathyroidism (pPTH). Women (60 and older) undergoing neck exploration for pHPT will be assessed for general functional parameters (gait, balance, and muscle power and strength) and clinical criteria for frailty (Fried’s criteria) before and after (3 months) surgery. Women of the same age undergoing neck exploration for benign nontoxic goiter will serve as controls. This study will provide a new understanding of the role of PTH in the pathophysiology of frailty. We will also identify novel potential interventions to prevent frailty, falls and fractures in high-risk older persons with alterations in their calciotropic hormones.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98226 0
Prof Gustavo Duque
Address 98226 0
AIMSS - Level 3 WCHRE, 176 Furlong Road, St Albans, VIC, 3021, Australia
Country 98226 0
Australia
Phone 98226 0
+61 03 83958121
Fax 98226 0
Email 98226 0
gustavo.duque@unimelb.edu.au
Contact person for public queries
Name 98227 0
Dr Lavanya Srinivasa Murthy
Address 98227 0
AIMSS - Level 3 WCHRE, 176 Furlong Road, St Albans, VIC, 3021, Australia
Country 98227 0
Australia
Phone 98227 0
+61 03 83958233
Fax 98227 0
Email 98227 0
lsrinivasamu@student.unimelb.edu.au
Contact person for scientific queries
Name 98228 0
Dr Lavanya Srinivasa Murthy
Address 98228 0
AIMSS - Level 3 WCHRE, 176 Furlong Road, St Albans, VIC, 3021, Australia
Country 98228 0
Australia
Phone 98228 0
+61 03 83958233
Fax 98228 0
Email 98228 0
lsrinivasamu@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results