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ISRCTN
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ISRCTN66569335
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ClinicalTrials.gov identifier
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Public title
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Evaluating fracture risk in asymptomatic and normocalcemic Primary Hyperparathyroidism (PHPT)
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Scientific title
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Evaluating fracture risk in asymptomatic and normocalcemic Primary Hyperparathyroidism (PHPT): a cohort study
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Acronym
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FRIP
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Serial number at source
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2011/125
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Study hypothesis
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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)
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Lay summary
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Lay summary under review
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Ethics approval
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Not provided at time of registration
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Study design
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Cross sectional clinical assessment study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Primary Hyperparathyroidism (PHPT)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2012
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Anticipated end date
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31/07/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Validity of DXA-based VDA (Vertebral Deformity Assessment) in identifying vertebral fracture in comparison to gold-standard radiograph assessment
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Sources of funding
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Ipswich Hospital NHS Trust R&D (UK)
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Trial website
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Publications
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Contact name
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Dr
Gavin
Clunie
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Address
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Ipswich Hospital
Rheumatology Dept
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City/town
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Ipswich
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Zip/Postcode
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IP4 5PD
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Country
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United Kingdom
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Email
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gavin.clunie@doctors.org.uk
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Sponsor
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Ipswich Hospital R&D Dept (UK)
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Address
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Heath Rd
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City/town
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Ipswich
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Zip/Postcode
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IP4 5PD
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Country
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United Kingdom
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Email
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frances.farnsworth@ipswichhospital.nhs.uk
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Date applied
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07/12/2011
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Last edited
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10/02/2012
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Date ISRCTN assigned
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10/02/2012
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