- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00432939
Primary Hyperparathyroidism: Non-classical Manifestations
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This study involves a total of 4 visits over a 2-year period. A variety of tests to evaluate your cardiovascular and bone health are performed. The details and timing of the tests are explained below.
VISIT #1 During the first visit, a research doctor or assistant explains the procedures in detail and answers questions. Blood is drawn (about 1-2 tablespoons) to confirm the diagnosis of hyperparathyroidism and get baseline blood values.
VISIT #2-4 During the following visits, a variety of procedures are performed to evaluate cardiovascular and bone health. The details of the procedures and when they will be performed are outlined below.
- Blood tests are performed at each visit. Approximately 1-2 tablespoons of blood will be drawn at each visit.
- A 24-hour urine collection is done 3 times during the 2 year study.
- Bone mineral density testing (known as DXA) is performed at baseline, 12 and 24 months after enrollment.
- Carotid Ultrasound: At the baseline visit, 12 and 24 months after enrollment, carotid ultrasound is performed.
- Echocardiogram: At the baseline visit, 12 and 24 months after enrollment, an echocardiogram is performed.
- Endothelial Function: At baseline, 6 and 12 months after enrollment, flow mediated dilation of the brachial artery is performed.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Metabolic Bone Diseases Unit
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
-Primary Hyperparathyroidism
Exclusion Criteria:
- Current use of oral bisphosphonates
- Addition or change in cholesterol lowering medication
- impaired renal function (creatinine >2.0 mg/dl)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT
Tidsramme: 2 years
|
To determine whether or not there is structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT as compared to matched healthy controls, and to determine the reversibility of these manifestations after successful parathyroidectomy
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT
Tidsramme: 2 years
|
To determine whether or not there is evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT, and to determine the reversibility of these manifestations after successful parathyroidectomy
|
2 years
|
Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery
Tidsramme: 2 years
|
To determine whether or not there is evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery, and to determine the reversibility of these manifestations after successful parathyroidectomy
|
2 years
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function
Tidsramme: 2 years
|
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function as assessed in outcomes 1 to 3
|
2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Shonni J Silverberg, MD, Columbia University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AAAB1955
- R01DK066329 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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