Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000427
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2000-01-18
Brief Title:
Effects of Parathyroid Hormone in Men With Osteoporosis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Anabolic Actions of Parathyroid Hormone in Osteoporotic Men
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Alendronate is a drug that blocks or reduces bone loss while parathyroid hormone PTH stimulates the formation of new bone The purpose of this study is to compare the bone-building effects of PTH alone alendronate alone and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period
Detailed Description:
Osteoporosis causes bones to weaken and break more easily Alendronate is used to treat or prevent osteoporosis PTH is a protein hormone that increases the calcium and phosphorus release from bone leading to formation of new bone This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men
Participants will be randomly assigned to receive PTH alone by daily injection under the skin alendronate alone taken by mouth or both PTH and alendronate The study will last 25 years All participants will receive some form of treatment for osteoporosis Blood urine and bone density tests will be performed at 6-month intervals During the first 6 months participants will come in for additional study visits
Participants who complete the initial 25 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped Participants who were receiving alendronate will continue taking alendronate The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain
Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy Participants who have been receiving alendronate continue taking alendronate The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment
Participants will be randomly assigned to receive PTH alone by daily injection under the skin alendronate alone taken by mouth or both PTH and alendronate The study will last 25 years All participants will receive some form of treatment for osteoporosis Blood urine and bone density tests will be performed at 6-month intervals During the first 6 months participants will come in for additional study visits
Participants who complete the initial 25 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped Participants who were receiving alendronate will continue taking alendronate The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain
Participants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy Participants who have been receiving alendronate continue taking alendronate The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment
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 |
|---|---|---|---|
| P50AR044855 | NIH | None | None |
| NIAMS-015 | US NIH GrantContract | None | httpsreporternihgovquickSearchP50AR044855 |