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NCT01301183 · ClinicalTrials.gov registry record · Phase 3
Effects of Anorexia Nervosa on Peak Bone Mass
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT01301183: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT01301183 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01301183, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of bone accrual, raising concerns regarding acquisition of peak bone mass, an important determinant of future bone health and fracture risk. Important factors contributing to low bone density in AN include low levels of estrogen and insulin like growth factor-1 (IGF-1). While estrogen is important for preventing bone loss, IGF-1 is important for optimizing bone formation. We have shown in a previous study that replacement of estrogen is effective in increasing bone density in teenage girls with AN; however, this increase in bone density remains lower than that seen in normal-weight controls over the same duration, and residual deficits persist. Importantly, the impact of administering replacement doses of IGF-1 with estrogen replacement has not been studied in teenagers with AN. This study will examine the impact of administering recombinant human (rh) insulin like growth factor-1 (rhIGF-1) with estrogen (to mimic pubertal levels of these hormones) versus administration of estrogen alone on bone metabolism in adolescent girls with anorexia nervosa (AN). One aim of this proposal is to investigate whether co-administration of insulin like growth factor-1 (rhIGF-1) with physiologic estradiol replacement to adolescent girls with AN will increase BMD (bone mineral density) more than estrogen monotherapy, and whether bone mass will approach that seen in healthy adolescent girls. An additional aim is to determine whether co-administration of rhIGF-1 with estradiol to mimic the normal pubertal milieu stimulates bone formation through an IGF-1 mediated anabolic effect, increases bone density to a greater extent than estrogen monotherapy, and improves bone mass accrual to approach that in healthy controls. The impact of rhIGF-1 +estradiol versus estradiol alone on bone microarchitecture will also be assessed.
Interventions
- DRUG RhIGF-1 with transdermal 17-beta estradiol
- DRUG Placebo and transdermal 17-beta estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-02 |
| Est. Completion | 2020-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01301183
The ClinicalTrials.gov registry entry for NCT01301183 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RhIGF-1 with transdermal 17-beta estradiol is the first listed.
NCT01301183 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01301183 about?
NCT01301183 is a clinical study titled "Effects of Anorexia Nervosa on Peak Bone Mass". Teenage girls with anorexia nervosa (AN) are at risk for low bone density and low rates of bone accrual, raising concerns regarding acquisition of peak bone mass, an important determinant of future bone health and fracture risk. Important factors contributing to low bone density in AN include low le...
What is the current status of trial NCT01301183?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2011-02. Estimated completion is 2020-03.
What interventions are being tested in trial NCT01301183?
The interventions under investigation include: RhIGF-1 with transdermal 17-beta estradiol (DRUG), Placebo and transdermal 17-beta estradiol (DRUG).
Who is sponsoring clinical trial NCT01301183?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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