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Monoclonal Antibodies
Anabolic Therapy for Osteoporosis
Phase 4
Waitlist Available
Led By Benjamin Leder, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 0 to 12
Awards & highlights
Study Summary
This trial will compare two different medications to see which is more effective in the treatment of osteoporosis.
Who is the study for?
This trial is for postmenopausal women at high risk of fracture. Participants must not have severe kidney disease, uncontrolled skin conditions, very low or high calcium levels, certain bone diseases other than osteoporosis, recent heart issues, or a history of significant lung disease. They should not have used specific osteoporosis treatments recently and must not be currently abusing substances.Check my eligibility
What is being tested?
The study compares two FDA-approved medications for treating osteoporosis: Denosumab and Romosozumab. It aims to understand their effects in preventing fractures in postmenopausal women who are at a higher risk.See study design
What are the potential side effects?
Possible side effects include skin reactions at the injection site, low calcium levels in the blood (hypocalcemia), infections including those of the ear and urinary tract, joint pain (arthralgia), headache, nausea or vomiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 0 to 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 0 to 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total hip areal bone mineral density
Trial Design
2Treatment groups
Active Control
Group I: RomosozumabActive Control1 Intervention
Group II: Romosozumab and denosumabActive Control2 Interventions
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
19 Trials studying Osteoporosis
1,275 Patients Enrolled for Osteoporosis
Benjamin Leder, MDPrincipal InvestigatorMass. General Hospital
3 Previous Clinical Trials
129 Total Patients Enrolled
3 Trials studying Osteoporosis
129 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely reduced.Your blood test shows high levels of alkaline.I have used oral bisphosphonates or denosumab in the last year.I am a postmenopausal woman at high risk for breaking bones.Your blood has a high level of PTH (parathyroid hormone) above 77 pg/mL.You drink too much alcohol or use drugs in a way that would make it hard for you to understand the study or follow the rules.I have a serious lung condition.I have used romosozumab or strontium before.I have used estrogens, SERMs, or calcitonin in the last 3 months.You have high levels of calcium in your blood.Your hematocrit level is below 32%.I have not had a heart attack or stroke in the last year.I have had unstable chest pain or a mini-stroke in the last year.I have used steroids for more than 2 weeks in the last 6 months.My doctor thinks I have a high risk for heart problems.I currently have atrial fibrillation.Your eczema is not under control.You are allergic to romosozumab or any of its ingredients.Your blood calcium level is lower than 8.8 mg/dL.I have not received certain treatments before.You are allergic to denosumab or any of its ingredients.I have a bone condition that is not osteoporosis.Your blood test shows that you have very low vitamin D levels.I have had major dental work recently or plan to soon.I have had cancer before, but not skin cancer.I have not used teriparatide, abaloparatide, or injectable bisphosphonates in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Romosozumab
- Group 2: Romosozumab and denosumab
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are partaking in the research protocol?
"Affirmative. Clinicaltrials.gov states that this medical trial is currently procuring participants, as first published on March 24th 2022 and revised July 14th of the same year. 46 individuals are needed to be enrolled at a single location."
Answered by AI
Could you provide a synopsis of the research done on Romosozumab to date?
"Presently, 54 Romosozumab trials are being conducted globally with 14 of those in the final Phase 3; these studies originate from Izmir and Madrid but span across 522 locations."
Answered by AI
What primary ailment is Romosozumab used to treat?
"Romosozumab is regularly used to manage skeletally mature patients, and has been observed as a successful treatment for conditions like osteoporosis, malignant neoplasms and disorders related to high concentrations of androgens."
Answered by AI
Has Romosozumab obtained official clearance from the FDA?
"Romosozumab is considered to be of high security as it has been approved for use in Phase 4 trials, so we rate its safety with a 3 on our scale."
Answered by AI
Is the research team seeking additional volunteers for this investigation?
"According to information on clinicaltrials.gov, this study is actively recruiting participants. The trial was first made available within the public domain on March 24th 2022 and underwent its last revision at July 14th of the same year."
Answered by AI
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