Secondary Hyperparathyroidism Clinical Trial
| NCT number | NCT00446329 |
| Other study ID # | 109/16-01-2007 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 4 |
| First received | March 9, 2007 |
| Last updated | October 28, 2014 |
| Start date | July 2006 |
| Verified date | October 2014 |
| Source | Papageorgiou General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: Ministry of Health and Welfare |
| Study type | Interventional |
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and
phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per
day.
The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD
(bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to
control secondary hyperparathyroidism without simultaneous administration of other vitamin D
compounds.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age older than 18 yrs - On hemodialysis for at least 3 months (thrice weekly) - iPTH >300pg/ml or histological evidence of secondary hyperparathyroidism - Calcium > 8.1 mg/dl Exclusion Criteria: - Unstable clinical condition |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Greece | Papageorgiou General Hospital | Thessaloniki |
| Lead Sponsor | Collaborator |
|---|---|
| Papageorgiou General Hospital |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients | one year period | Yes |
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