Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065637
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2003-07-29
Brief Title:
Once Weekly Parathyroid Hormone for Osteoporosis
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
PTH Once Weekly Research POWR
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Daily parathyroid hormone PTH is approved by the FDA for the treatment of osteoporosis This study will evaluate the safety and effectiveness of PTH when given once a week
Detailed Description:
In osteoporosis skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone Fractures of the hip spine and wrists are most typical though fractures of the ribs pelvis and humerus also occur Research has shown that hip fractures cause a 10 to 20 increase in mortality and the cost of all osteoporotic fractures is estimated to be 614 billion in health care costs and lost earnings per year The most common form of osteoporosis is postmenopausal osteoporosis A reduction in bone mineral density of approximately 1 to 2 per year is observed for the first 3 to 5 years after the onset of menopause then 05 to 1 per year thereafter
PTH was recently approved by the FDA as a daily treatment for osteoporosis However PTH must be self-injected is very expensive and has been associated with worrisome side effects The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis A once weekly formulation could significantly decrease cost difficulty of administration and risks and side effects associated with daily use of PTH A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical such as the very elderly or those in assisted living or nursing homes This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis
Women will be randomized to receive either PTH or placebo Women will self-administer injections daily for 4 weeks then once weekly for 48 weeks All women will receive calcium and vitamin D supplements daily Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit Bone mineral density will be measured at 6 and 12 months
PTH was recently approved by the FDA as a daily treatment for osteoporosis However PTH must be self-injected is very expensive and has been associated with worrisome side effects The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis A once weekly formulation could significantly decrease cost difficulty of administration and risks and side effects associated with daily use of PTH A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical such as the very elderly or those in assisted living or nursing homes This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis
Women will be randomized to receive either PTH or placebo Women will self-administer injections daily for 4 weeks then once weekly for 48 weeks All women will receive calcium and vitamin D supplements daily Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit Bone mineral density will be measured at 6 and 12 months
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 |
|---|---|---|---|
| NIAMS-092 | US NIH GrantContract | None | httpsreporternihgovquickSearchN01AR002245-000 |
| N01AR002245-000 | NIH | None | None |