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Romosozumab for Anorexia Nervosa
Study Summary
This trial is investigating whether the drug romosozumab is effective in increasing bone mineral density in women with anorexia nervosa, as well as investigating the safety of the drug in this population. The trial will compare the effects of romosozumab to placebo, and will also offer subjects the chance to take alendronate after the initial 12 months of the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 30 Patients • NCT03292146Trial Design
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- I agree to use a highly effective birth control method.I have jawbone damage or risk factors like recent major dental work, poor oral hygiene, gum/dental disease, or I'm using corticosteroids.I haven't taken any bone-affecting drugs in the last 3 months, except for birth control or estrogen.I have a weak immune system or am taking medication to suppress my immunity.I am female.I have been diagnosed with osteomalacia.I have diabetes.I have a condition that affects my bones, like thyroid issues, Cushing's, or kidney problems.You have a very low body weight for your height.I have not had a heart attack or stroke in the past year.I am between 20 and 60 years old and my bones have stopped growing.My kidney function is low.You are allergic or sensitive to calcium or vitamin D supplements.Your blood test shows that your ALT levels are more than three times higher than the normal range.Your LDL cholesterol level is higher than 190 mg/dL.I plan to have a dental surgery within the next 2 years.I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.Low levels of calcium in the bloodYour vitamin D and calcium levels are within the normal range.I have been diagnosed with Paget's disease of bone.Your bone density score is lower than -1.0You are currently misusing drugs or alcohol.Your blood potassium level is less than 3.0 meq/L.Your blood test shows low levels of magnesium.I have had cancer before.I have been diagnosed with anorexia nervosa or atypical anorexia.I am female.I have not had a dental check-up in over a year.Your bone density test score is lower than -1.0.I am between 20 and 60 years old and my bones have stopped growing.I have been diagnosed with anorexia nervosa or atypical anorexia nervosa.
- Group 1: Active Romosozumab 210mg Injection
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any known dangers to Alendronate 70Mg Tab?
"There is some evidence to support the efficacy of Alendronate 70Mg Tab, as this medication has completed Phase 3 trials. Additionally, there is ample data confirming its safety, so it received a score of 3."
Are there other instances where Alendronate 70Mg Tab has been utilized in medical research?
"At the moment, there are 22 clinical trials studying Alendronate 70Mg Tab. 3 of these research programs have progressed to Phase 3 testing. Most trial sites for Alendronate are located in Douliu within Yunlin County; however, there are a total of 73 sites running these sorts of tests."
Does this research include patients that are in their senior years?
"According to the inclusion criteria for this research, 20 is the minimum age requirement while 60 years old is the maximum age limit."
Are participants being recruited for this experiment at present?
"That is correct. By consulting clinicaltrials.gov, one can see that this experiment is still looking for participants. This research was originally put up on September 20th 2021 and has been updated as recently as June 2nd of 2022. They are hoping to have 30 people between 1 different location sign up."
Could I qualify to help test this new medication?
"This anorexia nervosa clinical trial has room for approximately 30 patients that meet the age criteria of being between 20 and 60 years old."
For what purpose is Alendronate 70Mg Tab most often prescribed?
"Osteogenesis imperfecta is most commonly treated with Alendronate 70Mg Tab. This medication can also help patients manage osteoporosis, postmenopause, and paget’s disease."
How many individuals are being helped by this treatment?
"That is correct. The clinical trial detailed on clinicaltrials.gov is still looking for patients to enroll. This specific study was posted on September 20th, 2021 and was updated as recently as June 2nd, 2022. They are hoping to recruit 30 individuals from 1 site."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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