- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00432939
Primary Hyperparathyroidism: Non-classical Manifestations
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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New York
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New York, New York, Förenta staterna, 10032
- Metabolic Bone Diseases Unit
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Shonni J Silverberg, MD, Columbia University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAAB1955
- R01DK066329 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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Kliniska prövningar på Primär hyperparatyreos
-
St. Louis Joint Replacement InstituteOkändOmvänd eller Primary Total Shoulder | Rotator Manschett- Full Tjocklek- ReparationFörenta staterna