Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417612
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2006-12-28
Brief Title:
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone PTH Levels in X-linked Hypophosphatemic Rickets
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
The Role of Parathyroid Hormone in the Pathogenesis of Skeletal Disease in X-linked Hypophosphatemic Rickets XLH
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of paricalcitol a form of synthetic vitamin D in lowering parathyroid hormone PTH levels and reducing disease symptoms in children and adults with X-linked hypophosphatemic XLH rickets
Detailed Description:
XLH rickets is a rare inherited disorder in which the bones become painfully soft and bend easily because of a phosphate deficiency This genetic defect causes the kidneys to allow excretion of an inappropriately high amount of phosphate into the urine The kidneys are also unable to convert vitamin D into a form usable by the body resulting in inadequate amounts of active vitamin D Because vitamin D is needed to absorb calcium and phosphate from the intestine this deficiency further reduces phosphate levels Without the sufficient phosphate needed for normal bone growth individuals with XLH rickets typically develop skeletal malformations bone pain and abnormally bowed legs Hyperparathyroidism a condition in which the parathyroid glands excrete excess amounts of PTH also occurs frequently in individuals with XLH rickets and may play a significant role in the skeletal complications associated with XLH rickets The purpose of this study is to determine the effectiveness of paricalcitol in lowering PTH levels and reducing disease symptoms in individuals with XLH rickets
This study will last 12 months Participants will be randomly assigned to receive either paricalcitol or placebo taken in the form of two pills daily for the duration of the study During a baseline 3-day inpatient hospital stay participants will undergo a physical exam a cardiac ultrasound a bone scan blood collection and a radiographic skeletal survey The skeletal survey will include x-rays of various body parts Participants who are 18 years or younger will not undergo the radiographic skeletal survey Study visits for all participants will occur every 2 months until the end of the study These visits will include a physical exam review of disease symptoms blood and urine collection and a check of medication compliance
This study will last 12 months Participants will be randomly assigned to receive either paricalcitol or placebo taken in the form of two pills daily for the duration of the study During a baseline 3-day inpatient hospital stay participants will undergo a physical exam a cardiac ultrasound a bone scan blood collection and a radiographic skeletal survey The skeletal survey will include x-rays of various body parts Participants who are 18 years or younger will not undergo the radiographic skeletal survey Study visits for all participants will occur every 2 months until the end of the study These visits will include a physical exam review of disease symptoms blood and urine collection and a check of medication compliance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AR054086 | NIH | None | None |
| 1P50AR054086-01 | NIH | None | httpsreporternihgovquickSearch1P50AR054086-01 |