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RGB-14-P + Prolia® for Osteoporosis
Study Summary
This trial will compare the effects of two different osteoporosis treatments on postmenopausal women.
- Postmenopausal Osteoporosis
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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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Who is running the clinical trial?
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- You have a history of serious heart problems or currently have a heart condition.You are allergic to latex.You have experienced or currently have a type of leg fracture called "atypical femur fracture".Your thyroid condition is not currently well-controlled.You have had or currently have problems with your parathyroid gland within the past 5 years.You cannot tolerate or properly absorb calcium or vitamin D supplements.You have a history or currently have a condition called osteonecrosis of the external auditory canal, which affects the ear canal.You have had a condition called ONJ (osteonecrosis of the jaw) before or have risk factors for developing it, like having invasive dental procedures.You are currently taking medicine for osteoporosis.You have previously broken your hip or currently have a broken hip.You have taken denosumab or a similar medication before.You have a broken bone that is still in the process of healing.You have a history of bone problems like fractures or infections, or currently have bone metastases or diseases affecting your bones.
- Group 1: RGB-14-P (Main period)
- Group 2: Prolia® (Main period)
- Group 3: RGB-14-P (Transition period)
- Group 4: Prolia® (Transition period)
- Group 5: RGB-14-P (Continued till transition period)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the prior research on RGB-14-P?
"Hirslanden Klinik Aarau was the first to study RGB-14-P back in 2014 and, since then, 109 similar studies have been completed. Currently, 49 more are underway; a significant portion of which are based in Las Vegas, Nevada."
Do many hospitals in Canada participate in this clinical trial?
"4 research facilities are conducting this clinical trial. Some notable locations include Excel Clinical Research - Internal Medicine in Las Vegas and Global Health Research Center in Miami Lakes."
Has RGB-14-P undergone Food and Drug Administration testing for safety and efficacy?
"There is some evidence from past clinical trials to support the safety of RGB-14-P, and it has received a score of 3."
Are geriatric patients being included in this research?
"This particular clinical trial is only for patients aged 60 to 90. However, if you are not eligible for this study, there are 21 other trials for patients under 18 and 164 trials for patients above 65."
Can new patients join this trial at this time?
"That is correct, the clinical trial is actively looking for 434 participants from 4 different medical facilities. The information on the website was last updated on 2/22/2022, and the study was originally posted 9/21/2021."
What are the goals that this experiment is hoping to achieve?
"The main aim of this clinical trial is to measure the percentage change in lumbar spine bone mineral density (BMD) from baseline to Week 26 (Predose). Secondary outcomes that will be evaluated include the number of participants with anti-drug antibodies (ADAs) and neutralizing antibodies, the titre of ADAs against RGB-14-P, and the percentage change from baseline in total hip BMD."
Who is qualified to take part in this experiment?
"This clinical trial is recruiting 434 postmenopausal women between the ages of 60 and 90 who have been diagnosed with osteoporosis. Eligible participants must be able to walk and are not bedridden, have an absolute BMD consistent with T score ≤ 2.5 and ≥ 4.0 at the lumbar spine as measured by dual-energy X-ray absorptiometry (DXA) during the Screening Period, and have body weight ≥ 50 and ≤ 90 kg at the Screening Period."
For what therapeutic purposes is RGB-14-P most often used?
"RGB-14-P is most commonly used to heal bones and treating bone-related conditions. However, it can also be used to treat skeletally mature patients, those with androgen conditions, and those with malignant neoplasms."
How many people are actively participating in this research project?
"That is correct. The information on clinicaltrials.gov does show that this trial is still looking for participants. This particular trial was posted on September 21st 2021 and was updated February 22nd of this year. They are hoping to have 434 patients enrolled from 4 different locations."
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