Plain English Summary
Background and study aims
Primary hyperparathyroidism (PHPT) is a condition which is not uncommon in middle and older age where the hormone Parathyroid Hormone (PTH) is over produced in the body. This leads to high calcium levels in the blood, which can cause digestive symptoms, kidney stones, psychiatric abnormalities, and bone disease. A cure is achieved by surgically removing the parathyroid gland. PTH can also cause bone thinning (osteoporosis) which can lead to bones breaking easily. Patients with mild PHPT (asymptomatic PHPT) are often monitored rather than have surgery to remove the parathyroid gland(s), particularly if there is only modestly high calcium in the blood and/or there are no symptoms. However, the decision to refer patients for the operation somewhat depends on the effect of PHPT on the bones. Conventionally the bone assessment undertaken is just a measure of bone density (DEXA scan). However, there are now better ways of assessing bone health by determining the risk of fracture (e.g. the FRAX online tool – see: www.shef.ac.uk/FRAX). We aim to undertake a full fracture risk assessment using DEXA and FRAX and also measuring an important risk factor for bone fracture – risk of falls . We hope to find out whether the information from these tests affects whether a panel of experts would refer patients for an operation to remove the PTH gland or monitor the situation.
Who can participate?
Patients aged 50 or over with asymptomatic PHPT.
What does the study involve?
Participants undergo a DEXA examination, have back x-rays (to detect any previous spine fractures), a falls risk assessment and other basic clinical data will be collected simply in a research clinic, to enable us to make a FRAX fracture risk measure. A panel of specialists then considers all the information and decides whether the new information is enough to recommend a referral for surgery to remove the PTH gland (on the basis of their being high fracture risk) compared with previous bone assessments (bone density measurement by DEXA scan only).
What are the possible benefits and risks of participating?
Participants may benefit if the new assessments lead to a strong recommendation for surgery compared to what would have been advised based on the previous assessments.
Where is the study run from?
Ipswich Hospital NHS Trust (UK).
When is the study starting and how long is it expected to run for?
April to July 2012.
Who is funding the study?
Ipswich Hospital NHS Trust R&D Department (UK).
Who is the main contact?
Dr Gavin Clunie
gavin.clunie@doctors.org.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gavin Clunie
ORCID ID
Contact details
Ipswich Hospital
Rheumatology Dept
Ipswich
IP4 5PD
United Kingdom
-
gavin.clunie@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2011/125
Study information
Scientific title
Evaluating fracture risk in asymptomatic and normocalcemic Primary Hyperparathyroidism (PHPT): a cohort study
Acronym
FRIP
Study hypothesis
To evaluate comprehensively using X-Ray, Dual X-Ray Absorptiometry (DXA), FRAX® fracture risk tool, falls risk assessment and clinical data, what the fracture risk is in patients with PHPT and evaluate whether, by expert consensus, the advice to manage PHPT is changed - essentially the advisability of immediate parathyroidectomy or long-term monitoring of the condition - in comparison to conventional assessment methods (NIH 2002 criteria)
Ethics approval
Not provided at time of registration
Study design
Cross-sectional clinical assessment study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary Hyperparathyroidism (PHPT)
Intervention
Novel assessment methods: The overall term is 'comprehensive fracture risk assessment'. This uses:
1. Lateral spinal radiographs [Dual X-Ray Absorptiometry (DXA)} to evaluate whether previous spinal fractures have occurred
2. A composite fracture risk calculator/algorithm termed FRAX (www.shef.ac.uk/FRAX)
3. A falls risk evaluation
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of participants where clinical advice for PHPT management is changed by the (study) fracture risk assessment, from expert consensus, compared with conventional assessment methods of fracture risk
Secondary outcome measures
Validity of DXA-based VDA (Vertebral Deformity Assessment) in identifying vertebral fracture in comparison to gold-standard radiograph assessment
Overall trial start date
01/04/2012
Overall trial end date
31/07/2012
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
1. Patients >18y old
2. Male or female patients
3. Those who have an established diagnosis of a PHPT or must have been assessed by an Endocrinologist or Metabolic Bone Physician and then recommended to have non-surgical management of their PHPT
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. <18 years old
2. Those unable to give informed consent
3. Prisoners
4. Women who are preganant or breast feeding
5. Patients with PHPT who would not be suitable for either PTHx medically on safety grounds or where there are serious concerns about the success of an operation
6. Patients with FHH or other condition causing hypercalcemia
Recruitment start date
01/04/2012
Recruitment end date
31/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ipswich Hospital
Ipswich
IP4 5PD
United Kingdom
Sponsor information
Organisation
Ipswich Hospital R&D Dept (UK)
Sponsor details
Heath Rd
Ipswich
IP4 5PD
United Kingdom
-
frances.farnsworth@ipswichhospital.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Ipswich Hospital NHS Trust R&D (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary