Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310791
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2006-04-03
Brief Title:
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Effects of Adrenal and Gonadal Hormone Replacement in Young Women With Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2018-03
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 seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone dehydroepiandrosterone DHEA and estrogen replacement therapy or placebo we will determine the effects of an 18-month treatment course on bone mass circulating markers of bone turnover and serum levels of a factor insulin-like growth factor I IGF-I We are also studying if these therapies change bone structure to increase skeletal strength compared to placebo as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry DXA
Detailed Description:
Profound osteopenia is a frequent and often irreversible complication of anorexia nervosa AN Adolescents with AN often have a reduced peak bone mass and are at increased risk for early osteoporosis and fractures These young women have subnormal serum levels of gonadal steroids and the adrenal androgen dehydroepiandrosterone DHEA that may be associated with their low bone mineral density BMD Low DHEA levels are accompanied by decreased levels of insulin-like growth factor I IGF-I estrogen and testosterone Previous data from our group indicate that oral DHEA therapy in young women with AN increases lean body mass serum levels of bone formation markers and insulin-like growth factor I IGF-I and decreases urinary markers of bone resorption We also found that standard hormonal replacement therapy HRT significantly decreased bone resorption markers Information on the effects of these therapies on bone strength and ultimate fracture risk is lacking
In this project we will test the hypothesis that combined therapy with DHEA and estrogenprogestin will enhance bone mass in patients with AN through anabolic and antiosteolytic mechanisms We will test the hypothesis that 18 months of DHEA HRT will increase bone mineral density BMD and markers of bone formation while decreasing bone resorption markers in these patients The proposed study will examine whether restoring normal levels of DHEA and estrogen in these young women will increase bone mass during a critical period for bone accretion The study will also examine whether DHEAs anabolic effects on bone are mediated through the skeletal IGF-I regulatory system Using cross-sectional analyses of dual energy x-ray absorptiometry DXA data we will also measure indices of bone structural geometry to determine if mechanical strength is compromised in these young women and if strength is restored in response to combined anabolicantiresorptive therapy
To gain new information on the mechanisms underlying bone loss and fracture risk in young women with AN our research goals are
Specific Aim I Through a randomized controlled trial to measure the effects of an 18-month course of DHEA HRT on bone mass markers of bone turnover and serum levels of IGF-I compared to placebo Specific Aim II To determine whether combined therapy with adrenal and gonadal steroid replacement changes bone structure to increase strength compared to placebo as assessed through cross-sectional geometric analysis of DXA data
In this project we will test the hypothesis that combined therapy with DHEA and estrogenprogestin will enhance bone mass in patients with AN through anabolic and antiosteolytic mechanisms We will test the hypothesis that 18 months of DHEA HRT will increase bone mineral density BMD and markers of bone formation while decreasing bone resorption markers in these patients The proposed study will examine whether restoring normal levels of DHEA and estrogen in these young women will increase bone mass during a critical period for bone accretion The study will also examine whether DHEAs anabolic effects on bone are mediated through the skeletal IGF-I regulatory system Using cross-sectional analyses of dual energy x-ray absorptiometry DXA data we will also measure indices of bone structural geometry to determine if mechanical strength is compromised in these young women and if strength is restored in response to combined anabolicantiresorptive therapy
To gain new information on the mechanisms underlying bone loss and fracture risk in young women with AN our research goals are
Specific Aim I Through a randomized controlled trial to measure the effects of an 18-month course of DHEA HRT on bone mass markers of bone turnover and serum levels of IGF-I compared to placebo Specific Aim II To determine whether combined therapy with adrenal and gonadal steroid replacement changes bone structure to increase strength compared to placebo as assessed through cross-sectional geometric analysis of DXA data
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 |
|---|---|---|---|
| R01HD043869 | NIH | None | httpsreporternihgovquickSearchR01HD043869 |