Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000400
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
1999-11-03
Brief Title:
Alendronate andor Parathyroid Hormone for Osteoporosis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Bone Formation-Resorption Coupling and Osteoporosis
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:
This study looks at the effects of two medications alendronate and parathyroid hormone on bone mass and on bone formation and bone breakdown in women with osteoporosis We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone hPTH or alendronate or both for 25 years Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests Those who complete the study are eligible for one or two 12 month extension studies
Detailed Description:
This is a randomized prospective open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-1-34 alendronate or both every day for 25 years Participants initially come to Massachusetts General Hospital once a month and subsequently once every 3-6 months for measurements of serum and urine indices of bone formation and resorption serum and urine toxicity tests and DXAQCT measurements of bone mass One-third of the participants take hPTH-1-34 daily one-third take alendronate once daily and one-third take both daily Phase A months 0-30
Participants who complete Phase A are eligible for a 12 month extension study Phase B months 30-42 during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped
Participants who complete Phase B are eligible for a second 12 month extension study Phase C months 42-54 during which any alendronate treatment is continued without change and every participant takes hPTH 1-34
During Phases B and C these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption serum and urine toxicity tests and DXAQCT measurements of bone mass
Participants who complete Phase A are eligible for a 12 month extension study Phase B months 30-42 during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped
Participants who complete Phase B are eligible for a second 12 month extension study Phase C months 42-54 during which any alendronate treatment is continued without change and every participant takes hPTH 1-34
During Phases B and C these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption serum and urine toxicity tests and DXAQCT measurements of bone mass
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 | httpsreporternihgovquickSearchP50AR044855 |