Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086619
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2004-07-07
Brief Title:
Parathyroid Hormone PTH for Osteoporosis in Postmenopausal Women
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Evaluation of Factors That Affect Skeletal Responses to PTH
Status:
COMPLETED
Status Verified Date:
2013-09
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:
Parathyroid hormone PTH increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis However prolonged PTH treatment increases bone formation less and less over time This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation and optional sub-studies will test several potential reasons why PTHs effects on bone formation decline over time
Detailed Description:
In women with postmenopausal osteoporosis PTH increases bone mineral density more than anti-resorptive agents and its use markedly reduces the incidence of new spine and non-spine fractures Still PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy continues Biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline progressively
The study will last 18 months Blood urine and bone density tests will occur at screening At the start of the study participants will be randomly assigned to one of two PTH dose regimens Patients will go to Massachusetts General Hospital at Months 0 3 6 9 12 15 and 18 for blood and urine collection In addition bone density tests by DXA will be performed at Months 0 6 12 and 18 and by quantitative CT scans at Months 0 and 18 Approximately 6 weeks after any change in PTH dose each participants blood calcium will be checked 4 to 6 hours after that days PTH injection and her 24-hour urine calcium excretion will also be checked
Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption andor destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH
The study will last 18 months Blood urine and bone density tests will occur at screening At the start of the study participants will be randomly assigned to one of two PTH dose regimens Patients will go to Massachusetts General Hospital at Months 0 3 6 9 12 15 and 18 for blood and urine collection In addition bone density tests by DXA will be performed at Months 0 6 12 and 18 and by quantitative CT scans at Months 0 and 18 Approximately 6 weeks after any change in PTH dose each participants blood calcium will be checked 4 to 6 hours after that days PTH injection and her 24-hour urine calcium excretion will also be checked
Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption andor destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH
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 |
|---|---|---|---|
| 1P50AR044855 | NIH | None | httpsreporternihgovquickSearch1P50AR044855 |