CLINICAL TRIAL

Denosumab 60 MG/ML Prefilled Syringe [Prolia] for Osteoporosis

Recruiting · 18 - 65 · Female · New York, NY

This study is evaluating whether a new drug may help improve bone health for women with osteoporosis.

See full description

About the trial for Osteoporosis

Eligible Conditions
Osteoporosis · Premenopausal Idiopathic Osteoporosis

Treatment Groups

This trial involves 2 different treatments. Denosumab 60 MG/ML Prefilled Syringe [Prolia] is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Romosozumab Prefilled Syringe [Evenity]
DRUG
Denosumab 60 MG/ML Prefilled Syringe [Prolia]
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients between 18 and 65 years old. 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:
Low-trauma adult fractures that have a T-score or Z-score of less than or equal to -1.5 at the LS, TH, or FN. show original
The most effective contraception methods are those considered to be >99% effective by the CDC, such as a vasectomized partner, tubal ligation, hysterectomy, or IUD show original
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 6 month, 12 month, 18 month, 24 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 6 month, 12 month, 18 month, 24 month.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Denosumab 60 MG/ML Prefilled Syringe [Prolia] will improve 4 secondary outcomes in patients with Osteoporosis. Measurement will happen over the course of Baseline, 6 month, 12 month, 18 month, 24 month.

Percent change in distal radius BMD by DXA
BASELINE, 6 MONTH, 12 MONTH, 18 MONTH, 24 MONTH
Within-group percent change in distal radius BMD every 6 months
Percent change in femoral neck BMD by DXA
BASELINE, 6 MONTH, 12 MONTH, 18 MONTH, 24 MONTH
Within-group percent change in femoral neck BMD every 6 months
Percent change in total hip BMD by DXA
BASELINE, 6 MONTH, 12 MONTH, 18 MONTH, 24 MONTH
Within-group percent change in total hip BMD every 6 months
Percent change in lumbar spine BMD by DXA
BASELINE, 6 MONTH, 12 MONTH, 18 MONTH, 24 MONTH
Within-group percent change in lumbar spine BMD every 6 months

Who is running the study

Principal Investigator
A. C.
Prof. Adi Cohen, Associate Professor of Medicine at CUIMC
Columbia University

Patient Q & A Section

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

How many people get osteoporosis a year in the United States?

Nearly 20 million women in the United States will developed osteoporosis and the number is projected to elevate to more than 60 million cases in 2015.

Anonymous Patient Answer

What causes osteoporosis?

This article presents a brief explanation and example of the link between Osteoporosis and gender as well as specific causes of Osteoporosis including medications, hormone replacement therapy, pregnancy, rheumatoid arthritis, nutritional deficiencies and some metabolic disorders.

Anonymous Patient Answer

What are the signs of osteoporosis?

Osteoporosis is an insidious condition and it can go unnoticed. Since many patients with osteoporosis do not present with any symptoms, clinicians may need to routinely screen patients' families for osteoporosis and consider treatment if symptoms are seen to occur. Many people with osteoporosis remain asymptomatic. Treatment of symptomatic patients with osteoporosis requires careful analysis of fracture risk and patient preferences. The treatment of asymptomatic patients with osteoporosis consists of screening, counselling, medications, and bisphosphonates and anti-androgens to treat the symptoms caused by the bone loss in women and to prevent osteoporotic fractures.

Anonymous Patient Answer

What are common treatments for osteoporosis?

Vitamin D deficiency is highly prevalent in the general population. It may be asymptomatic, but there is a significant association between high-impact fractures and Vitamin D deficiency. Although Vitamin D deficiency is asymptomatic it has adverse effects on several tissues including the bone. The effects of Vitamin D deficiency are reversible upon correction of Vitamin D depletion. Vitamin D analogs, with better bioavailability and longer duration of action than Vitamin D (paricalcitol), are used in place of Vitamin D in the treatment of vitamin D deficiency. There is a high prevalence of osteoporosis in post-menopausal women especially in post-menopausal women who use estrogen-progestin medications.

Anonymous Patient Answer

What is osteoporosis?

Osteoporosis is a disease of women of late middle age and of postmenopausal age which causes bone resorption without bone formation. The result can be a decrease in bone mineral density and an elevated risk of bone fractures. Women should be screened for osteoporosis with their physicians when they are 50 to 60 years of age. Women who are diagnosed with osteoporosis should be assessed for the risk of fracture, and be educated on the signs and symptoms of osteoporosis. Treatment for osteoporosis can include drugs, a hormone replacement supplement, and lifestyle changes. (National Institute on Aging).

Anonymous Patient Answer

Can osteoporosis be cured?

Oral etidronate with regular exercise may improve the bone micro-architecture in patients with postmenopausal osteoporosis, but does not improve bone mineral density or the incidence of osteoporotic fractures.

Anonymous Patient Answer

Does osteoporosis run in families?

Osteoporotic individuals are not more likely to have a bone disorder in any member of the family than are individuals without osteoporosis; thus familiality of osteoporotic disease is minimal. However, as a family history is generally observed among more symptomatic cases, we can hypothesise that familial factors play a role in the development of osteoporosis.

Anonymous Patient Answer

Have there been any new discoveries for treating osteoporosis?

There have been many attempts, unfortunately none has been successful so far. In summary, there are also a lot of misconceptions about osteoporosis and the medical facts about it. Data from a recent study, we have shown which exercises are helpful, which are not, and which are more suitable alternatives, for example: regular exercise, stretching exercises, weight bearing exercises, and balance training exercises. Another good source is a web based medical review book that was written by Dr. P. Gebhardt and published by the “Arbeitsgemeinschaft für osteoporose und osteoporosis” und is the basis for the current paper.

Anonymous Patient Answer

What are the common side effects of denosumab 60 mg/ml prefilled syringe [prolia]?

Denosumab is a well-tolerated medication that causes a wide range of common side effects regardless of the clinical condition. Most side effects are mild to moderate. The magnitude of most side effects is similar regardless of the dose. A dose as low as 60 mg/ml prefilled syringe [prolia] is as safe as doses of 70 or 90 mg/ml.

Anonymous Patient Answer

Does denosumab 60 mg/ml prefilled syringe [prolia] improve quality of life for those with osteoporosis?

Denosumab 60 mg/ml prefilled syringe significantly improves most domains of all three-item instruments that measure HRQOL when used with a standard oral regimen over 10 months in women with osteoporosis.

Anonymous Patient Answer

Has denosumab 60 mg/ml prefilled syringe [prolia] proven to be more effective than a placebo?

The study has found that denosumab 60 mg prefilled syringe with a lower dose delivered over 2 years is more effective than a placebo in preventing vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. In addition it was associated with a decreased risk of serious adverse events.

Anonymous Patient Answer

Who should consider clinical trials for osteoporosis?

A positive attitude towards randomized clinical trials for osteoporosis in general and for specific medications is associated with a higher propensity toward enrollment in a research study, but there is no evidence of bias within the population.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Osteoporosis by sharing your contact details with the study coordinator.