CLINICAL TRIAL

RGB-14-P for Osteoporosis, Postmenopausal

Recruiting · 18+ · Female · Decatur, GA

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

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About the trial for Osteoporosis, Postmenopausal

Eligible Conditions
Osteoporosis, Postmenopausal · Postmenopausal Osteoporosis · Osteoporosis

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.

Experimental Group 1
RGB-14-P
DRUG
Experimental Group 2
RGB-14-P
DRUG
Experimental Group 3
RGB-14-P
DRUG
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Eligibility

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden
Participant has 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 at least 2 lumbar vertebrae (from L1 to L4) must be evaluable by DXA
Participant has body weight ≥ 50 and ≤ 90 kg at the Screening Period
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78.
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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).

Area under the effective curve after the first dose until Day 183 of percentage change from baseline in serum type I collagen C-telopeptide up to month 6 (AUEC of %CfB in sCTX00-m6) until Week 26
BASELINE, UNTIL WEEK 26 (PREDOSE)
Similar pharmacodynamics (AUEC of %CfB in sCTX) of RGB-14-P with US-licensed Prolia® in female participants will be demonstrated with postmenopausal osteoporosis.
Percentage change from baseline in lumbar spine bone mineral density (BMD)
BASELINE, WEEK 52
Efficacy and effect similarity of RGB-14- P with US-licensed Prolia® on BMD at the lumbar spine at Week 52 will be determined in female participants with postmenopausal osteoporosis.
Percentage change from baseline in lumbar spine BMD
BASELINE, WEEKS 26 AND 78
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Number of participants with adverse events (AEs)
FROM SCREENING (WEEKS -5 TO 0) UNTIL WEEK 78
The safety and tolerability of RGB-14-P with US-licensed Prolia® will be compared in female participants with postmenopausal osteoporosis will be compared.
Non-vertebral fragility fracture incidence
WEEKS 52 AND 78
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Vertebral fragility fracture incidence
WEEKS 52 AND 78
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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