RGB-14-P for Osteoporosis, Postmenopausal
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
See full descriptionAbout the trial for Osteoporosis, Postmenopausal
Treatment Groups
This trial involves 5 different treatments. RGB-14-P is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
Eligibility
This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether RGB-14-P will improve 2 primary outcomes and 11 secondary outcomes in patients with Osteoporosis, Postmenopausal. Measurement will happen over the course of Baseline, until Week 26 (Predose).
Patient Q & A Section
What are common treatments for osteoporosis, postmenopausal?
A variety of medications were found to be commonly used for osteoporosis. No medications are known to be more frequently prescribed than others, but there is an emphasis on estrogen replacement therapy and oral bisphosphonates.
What causes osteoporosis, postmenopausal?
A woman is more likely to be osteopenic if she has a first or second degree relative who is a postmenopausal survivor of a hip fracture. We hypothesize that this may be due to some kind of hormonal effects on bone turnover, which may cause a reduction in bone density during puberty and later.
What is osteoporosis, postmenopausal?
Osteoporosis is a disease of bones in which bones become brittle so that they break easily and can result in serious loss of bone mass. Osteoporosis is commonly diagnosed in post-menopausal women. Osteoporosis and menopause-related osteoporosis are closely related disorders. Osteoporosis is a common disease in post-menopausal women and a great number of osteoporosis cases in these women in Vietnam have an unknown etiology because of a lack of adequate medical care and diagnostic tools. Preventative programmes for osteoporosis must be implemented and more effective diagnostic tools must be developed.
How many people get osteoporosis, postmenopausal a year in the United States?
Most women get Osteoporosis, postmenopausal a year, nationwide. However, one in five women does not get Osteoporosis, postmenopausal a year. Although women ages [over 50 years) get Osteoporosis, postmenopausal a year, this condition represents the leading cause of age-related bone loss. Osteopenia or osteoporotic fracture are also major reasons for disability due to Bone loss. Therefore, primary prevention is an important issue for future research.
Can osteoporosis, postmenopausal be cured?
Only a balanced nutrition combined with a low total estradiol concentration at the time of estrogen treatment of postmenopause can reduce the occurrence of bone loss. It will be helpful to establish the appropriate treatment of osteoporosis, including the proper dosage, type and method of estrogen therapy.
What are the signs of osteoporosis, postmenopausal?
The key signs include bone mass loss, bone pain, fractures, and spinal fractures. In the presence of any one of these symptoms of osteoporosis, this disease must be suspected. Postmenopausal osteoporosis can be identified by a patient's self-report and by a physician performing a physical examination. The risks and benefits of treatment, including surgery, are important determinants of the best strategy for postmenopausal osteoporosis.
How does rgb-14-p work?
[The new noninvasive technique of spectral-spatial quantitative targeted MR elastography (SSB-QTMRE) enables clinicians to evaluate bone strength and bone density in live rats through a process termed quantitative targeted MR attenuation (QTRAT)\n
What is the average age someone gets osteoporosis, postmenopausal?
Age adjusted osteoporosis prevalence is increasing. Osteoporosis is not associated with age independently from hormonal status and risk factor; we hypothesize that in postmenopausal women, menopause induced hormonal change, associated with osteoporosis, might play a role since it is associated with lower bone density.
What is the primary cause of osteoporosis, postmenopausal?
[Age > 50 years is the risk factor for osteoporosis(https://www.fao.org/bio/info/pages/205728fdb.html), especially in postmenopausal women. However, there is also a growing body of evidence that men also have a low risk of osteoporosis, [but] more importantly men with early stage osteoporosis, should have their bone density measured regularly on the basis of their risks. This [information, and] [its] link to osteoporosis treatment should be widely disseminated to women on the basis of [this] guideline(https://www.fao.
Have there been other clinical trials involving rgb-14-p?
A significant number of recent clinical trials in postmenopausal osteoporosis with a specific rPTH assay used in conjunction (rgb-14-p) with or without alendronate are listed in the publication referenced. However, none of these trials have reported results of any clinical significance.
Does osteoporosis, postmenopausal run in families?
In families where a parent has a verified osteoporosis diagnosis and the child is a male, there is a strong genetic component to the disease.
What are the latest developments in rgb-14-p for therapeutic use?
RGP in high doses over prolonged periods has many serious and undesirable adverse effects. Further research would be helpful to define appropriate dosing strategies and to formulate guidelines for patients.