Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089843
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2004-08-16
Brief Title:
Bone Loss in Women With Anorexia Nervosa
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
IGF-1 and Bone Loss in Women Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Women with Anorexia Nervosa have been found to have low bone density The study will determine whether administration of low doses of a natural hormone testosterone andor risedronate a medication to help prevent bone breakdown will improve or prevent bone loss in this condition
Detailed Description:
II SPECIFIC AIMS
Severe osteopenia is a prevalent complication of anorexia nervosa AN affecting over half of all women with this disease Loss of 25-50 of total bone mass occurs frequently and is often permanent Although anorexia nervosa affects from 05-10 of college age women no successful therapeutic interventions have been developed for osteoporosis in this population Bone loss in anorexia nervosa is characterized by reduced bone formation coupled with increased bone resorption Anorexia nervosa results in a deficiency of testosterone Testosterone administration reduces bone resorption and data suggest that low-dose testosterone replacement therapy can increase surrogate markers of bone formation Bisphosphonates are now well established to decrease bone resorption and improve bone density in severely osteopenic postmenopausal women However there are few data regarding the use of this antiresorptive therapy in women with severe pre-menopausal bone loss Our preliminary data demonstrate that administration of a bisphosphonate decreases bone resorption and increases bone mass in women with AN after 6 and 9 months These are the first data to demonstrate a striking increase in bone density in such women We will test the hypothesis that a combined strategy to increase bone formation and decrease bone resorption by combining testosterone with a bisphosphonate will increase bone mass in anorexia nervosa
The following hypotheses will be tested
Specific Aim 1 Testosterone a nutritionally dependent bone trophic factor is a critical determinant of decreased bone formation in anorexia nervosa and administration of physiologic testosterone will increase bone formation and lean body mass in this disease
We will investigate in women with anorexia nervosa whether
A Bone formation is reduced in association with low serum testosterone B Testosterone deficiency is due to a combination of ovarian and adrenal defects resulting from undernutrition C Testosterone administration reverses testosterone deficiency leading to an acute and sustained increase in bone formation and a decrease in bone resorption D Administration of physiologic testosterone replacement stimulates increases in IGF-I levels in women with anorexia nervosa a mechanism for increased bone formation and bone density E Administration of physiologic testosterone replacement increases lean body mass a major determinant of bone density
Specific Aim 2 Long-term 12 months physiologic testosterone administration combined with a bisphosphonate increases bone density by a dual anabolic and anti-resorptive strategy
We will investigate in women with anorexia nervosa whether
A Physiologic testosterone administration increases bone density B Administration of a bisphosphonate decreases the excessive state of bone resorption and increases bone density C Co-administration of physiologic testosterone replacement and a bisphosphonate increases bone density to a greater degree than testosterone or a bisphosphonate alone by increasing bone formation and decreasing bone resorption
Severe osteopenia is a prevalent complication of anorexia nervosa AN affecting over half of all women with this disease Loss of 25-50 of total bone mass occurs frequently and is often permanent Although anorexia nervosa affects from 05-10 of college age women no successful therapeutic interventions have been developed for osteoporosis in this population Bone loss in anorexia nervosa is characterized by reduced bone formation coupled with increased bone resorption Anorexia nervosa results in a deficiency of testosterone Testosterone administration reduces bone resorption and data suggest that low-dose testosterone replacement therapy can increase surrogate markers of bone formation Bisphosphonates are now well established to decrease bone resorption and improve bone density in severely osteopenic postmenopausal women However there are few data regarding the use of this antiresorptive therapy in women with severe pre-menopausal bone loss Our preliminary data demonstrate that administration of a bisphosphonate decreases bone resorption and increases bone mass in women with AN after 6 and 9 months These are the first data to demonstrate a striking increase in bone density in such women We will test the hypothesis that a combined strategy to increase bone formation and decrease bone resorption by combining testosterone with a bisphosphonate will increase bone mass in anorexia nervosa
The following hypotheses will be tested
Specific Aim 1 Testosterone a nutritionally dependent bone trophic factor is a critical determinant of decreased bone formation in anorexia nervosa and administration of physiologic testosterone will increase bone formation and lean body mass in this disease
We will investigate in women with anorexia nervosa whether
A Bone formation is reduced in association with low serum testosterone B Testosterone deficiency is due to a combination of ovarian and adrenal defects resulting from undernutrition C Testosterone administration reverses testosterone deficiency leading to an acute and sustained increase in bone formation and a decrease in bone resorption D Administration of physiologic testosterone replacement stimulates increases in IGF-I levels in women with anorexia nervosa a mechanism for increased bone formation and bone density E Administration of physiologic testosterone replacement increases lean body mass a major determinant of bone density
Specific Aim 2 Long-term 12 months physiologic testosterone administration combined with a bisphosphonate increases bone density by a dual anabolic and anti-resorptive strategy
We will investigate in women with anorexia nervosa whether
A Physiologic testosterone administration increases bone density B Administration of a bisphosphonate decreases the excessive state of bone resorption and increases bone density C Co-administration of physiologic testosterone replacement and a bisphosphonate increases bone density to a greater degree than testosterone or a bisphosphonate alone by increasing bone formation and decreasing bone resorption
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 |
|---|---|---|---|
| R01DK052625 | NIH | None | None |
| 1UL1RR025758 | NIH | None | httpsreporternihgovquickSearch1UL1RR025758 |