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Romosozumab + Denosumab for Osteoporosis
Study Summary
This trial is testing a new osteoporosis treatment in premenopausal women to see if it is more effective than the current standard of care.
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.Trial Design
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- I have a history of heart disease but my recent ECG is normal or not concerning.I have a condition affecting my intestines, such as celiac disease or Crohn's.I have a new, untreated hormone gland disorder.I have a condition affecting my body's mineral levels, like vitamin D deficiency or hyperparathyroidism.I am currently using or have a history of using specific medications like steroids, anticonvulsants, blood thinners, methotrexate, or drugs to stop my periods.I stopped my osteoporosis medication as required before joining the trial.Your hormone levels show that you are not in the early stage of menopause.I have not had a menstrual period for over a year, not due to pregnancy or breastfeeding.I am on long-term blood thinners.I agree to use highly effective birth control during the study.My body releases too much calcium in my urine and treatments haven't worked.I may have bone softening due to symptoms like bone pain when standing and high enzyme levels.I have been taking more than 5 mg of prednisone or similar daily for over 3 months.I am a woman aged 18-48, premenopausal, with regular periods and no osteoporosis.I had an eating disorder that resolved over 5 years ago, lasting less than a year and started after I was 20.I am currently taking medication to stop new blood vessels from forming in my tumor.My vitamin D levels were low but are now ≥30 ng/ml after treatment.I have not taken Depo Provera in the last 5 years, or I started it after age 20.I have had fractures from minor falls and my bone density scores are low.You are allergic to romosozumab or denosumab.Low levels of calcium in the blood.My kidney function is reduced (eGFR below 60).I have cancer, but not skin cancer that's been cured.I haven't had major dental work in the last 3 months and don't need any in the next 2 years.I am currently using blood thinners, but I don't have a history of blood clots.My liver tests are higher than normal.
- Group 1: Romosozumab followed by denosumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does the Denosumab 60 MG/ML Prefilled Syringe [Prolia] have authorization from the FDA?
"Denosumab 60 MG/ML Prefilled Syringe [Prolia] has been evaluated to a rating of 2 due to the presence of some evidence indicating its safety, however no efficacy data exists at this time."
What medical conditions is Denosumab 60 MG/ML Prefilled Syringe [Prolia] commonly prescribed for?
"Denosumab 60 MG/ML Prefilled Syringe [Prolia] is commonly used to address skeletally mature patients. Beyond this, it has been proven effective for managing androgens, malignant neoplasms, and osteoporosis."
Does this experiment accept volunteers aged 25 and older?
"This study only admits individuals aged 18 to 45. Separately, 20 trials are available for those younger than 18 and 165 studies exist for seniors over the age of 65."
Is there any evidence of prior research on Denosumab 60 MG/ML Prefilled Syringe [Prolia]?
"Presently, 55 clinical trials are in progress testing Denosumab 60 MG/ML Prefilled Syringe [Prolia], 14 of which have arrived at Phase 3. While the bulk of studies lie in Izmir and Madrid, 538 sites across the world are currently investigating this therapeutical option."
Is this clinical endeavor currently accepting new participants?
"Indeed, clinicaltrials.gov holds evidence that this study is actively searching for volunteers; it was originally posted on March 12th of 2021 and updated as recently as October 5th 2022. 30 participants are required from a single location to participate in the investigation."
What is the enrollment scope of this investigation?
"Affirmative. The data available on clinicaltrials.gov verifies that this research study, which had its initial posting on March 12th 2021, is currently recruiting patients. Approximately 30 participants need to be recruited from only one medical centre."
Does my profile qualify me to participate in this investigation?
"This clinical trial is looking for 30 premenopausal women, aged 18-48 with regular menses and no secondary cause of osteoporosis. All participants under the age of 25 must undergo a bone age radiograph to ensure epiphyses are fused. Furthermore, all potential patients must have an adult fracture from low trauma equivalent to a fall from standing height or less as well as T-score/Z-score ≤ -1.5 at LS, TH or FN sites before being accepted into the study. Lastly, it is necessary that those participating use highly effective contraception methods throughout the duration of this trial administration (vasectom"
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