Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533865
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea cessation of the menstrual period due to intense exercise stress or an eating disorder who have low bone density Participants will be randomly assigned to receive romosozumab or placebo for 6 months All participants will receive one IV infusion of zoledronate at the 6 month visit All participants will also receive transdermal estradiol and cyclic progesterone We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo We will also compare bone density over a year with healthy controls girls and women of similar age who have regular menstrual periods
Detailed Description:
None
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