Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001720
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
1999-11-03
Brief Title:
Treatment of Childhood Osteoporosis With Alendronate Fosamax
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Bones grow and stay strong through a continuous process of formation building and resorption break down When more bone is formed than resorbed the density level of calcium in bone increases and the bones become stronger However if more bone is resorbed than formed the density of bone decreases and the bones become weak This condition is called osteoporosis
Osteoporosis is a rare but serious condition in children Childhood osteoporosis can occur without a known cause idiopathic juvenile osteoporosis Children with osteoporosis suffer from pain inability to stay active and increased amounts of broken bones including fractures of the spine Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition peak bone mass during the first 20-30 years of life may be at an increased risk for osteoporosis as adults
Alendronate Fosamax is a drug that works by stopping bone resorption break down It has been used to treat post-menopausal osteoporosis male osteoporosis and adults with osteoporosis due to long-term steroid therapy The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis
Osteoporosis is a rare but serious condition in children Childhood osteoporosis can occur without a known cause idiopathic juvenile osteoporosis Children with osteoporosis suffer from pain inability to stay active and increased amounts of broken bones including fractures of the spine Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition peak bone mass during the first 20-30 years of life may be at an increased risk for osteoporosis as adults
Alendronate Fosamax is a drug that works by stopping bone resorption break down It has been used to treat post-menopausal osteoporosis male osteoporosis and adults with osteoporosis due to long-term steroid therapy The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis
Detailed Description:
Osteoporosis is a rare but serious condition in children One of the least well understood forms of childhood osteoporosis is idiopathic juvenile osteoporosis Affected children suffer from pain decreased activity tolerance and increased fractures including vertebral compression fractures Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a lower peak bone mass during the first 2-3 decades of life may be at increased risk for osteoporosis as adults
Alendronate Fosamax Trademark Merck Co an aminobisphosphonate is a potent inhibitor of bone resorption It has been used to treat postmenopausal osteoporosis idiopathic male osteoporosis and glucocorticoid induced osteoporosis in adults The goal of this protocol is to evaluate the effectiveness of Alendronate in children with glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind randomized placebo-controlled study design We hypothesize that children treated with this drug will have an improvement in bone mineral density and decrease in osteoporotic fractures
Alendronate Fosamax Trademark Merck Co an aminobisphosphonate is a potent inhibitor of bone resorption It has been used to treat postmenopausal osteoporosis idiopathic male osteoporosis and glucocorticoid induced osteoporosis in adults The goal of this protocol is to evaluate the effectiveness of Alendronate in children with glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind randomized placebo-controlled study design We hypothesize that children treated with this drug will have an improvement in bone mineral density and decrease in osteoporotic fractures
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 |
|---|---|---|---|
| 98-CH-0077 | None | None | None |