Soluble Corn Fiber (SCF) + Calcium for Osteoporosis

Phase-Based Estimates
1
Effectiveness
2
Safety
Citrus Health Network, Miami, FL
Osteoporosis
Soluble Corn Fiber (SCF) + Calcium - CombinationProduct
Eligibility
< 18
All Sexes
Eligible conditions
Osteoporosis

Study Summary

This study is evaluating whether a fiber supplement may help improve bone health in adolescents.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Soluble Corn Fiber (SCF) + Calcium will improve 2 primary outcomes and 18 secondary outcomes in patients with Osteoporosis. Measurement will happen over the course of 12 months.

12 months
Change in body fat
Change in bone alkaline phosphatase
Change in bone mineral content (BMC)
Change in bone specific alkaline phosphatase
Change in osteocalcin
Change in parathyroid hormone (PTH)
Change in phylogenetic diversity of bacterial communities
Change in serum calcium
Change in serum carboxy-terminal collagen crosslinks (CTX)
Change in serum creatinine
Change in serum insulin growth factor 1 (IGF-I).
Change in serum phosphate
Change in spine BMC
Change in total BMD
Change in total bone mineral density (BMD)-z score
Change in urinary N-telopeptide cross-links
Change in urinary calcium
Change in urinary creatinine
Change in urinary phosphorus
Change in vitamin D status

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

Soluble Corn Fiber (SCF) without calcium
Soluble Corn Fiber (SCF) + Calcium
Placebo group

This trial requires 240 total participants across 4 different treatment groups

This trial involves 4 different treatments. Soluble Corn Fiber (SCF) + Calcium is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Soluble Corn Fiber (SCF) + Calcium
CombinationProduct
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without calcium
DietarySupplement
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo
DietarySupplement
This group will receive a similar supplement without SCF or calcium, administered twice a day
Placebo + calcium
CombinationProduct
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
C. P.
Prof. Cristina Palacios, PhD
Florida International University

Closest Location

Citrus Health Network - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.

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?

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The number of people who are diagnosed with osteoporosis and experience bone fractures has steadily declined over the past five years for women and men. About two-thirds of women and more than half of men are considered at high risk for developing hip fractures due to BMD below the current T-score cutoff point.

Unverified Answer

What causes osteoporosis?

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Osteoporosis may be associated with estrogen deficiency in postmenopausal women, but also with decreased calcium intake or some abnormality of the bone metabolism. It may be associated with low calcium diet or the use of steroids or growth hormone.\n

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What are the signs of osteoporosis?

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There is a tendency of pathologists to overestimate osteoporosis, which may be an effect of their limited experience and the tendency to consider osteoporosis in elderly patients with benign complaints such as osteoporotic vertebral fracture. These patients have a relatively young age, and osteoporosis usually appears without radiologically detectable osteoporosis. The signs of osteoporosis include: 1) Osteoporotic vertebral fracture; 2) Osteopenia found by DEXA scan; and 3) Decreased bone mineral density found by Dual-energy X-ray absorptiometry. Osteopenia on DXA signifies low bone density but not the presence of osteoporosis.

Unverified Answer

What are common treatments for osteoporosis?

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Results from a recent paper of the Canadian population (2009/2014) revealed that most osteoporotic women receive a bisphosphonate. Women with a low body mass index are less likely to have received bisphosphonates compared with women who are overweight, while prescription rates for osteoporosis were similar for men and women.

Unverified Answer

Can osteoporosis be cured?

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Overall, the study indicated that the effects of glucosamine treatment for OA and its effect on fracture prevention are similar to placebo. These positive and negative findings are similar to those reported in a recent systematic review and meta-analysis concerning chondroitin sulfate, and in both cases there is no evidence of an effect on QoL or death.

Unverified Answer

What is osteoporosis?

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In summary, osteoporosis refers to bone loss caused by bone fragility, in which there is an increased risk of fracture. Osteoporosis occurs due to loss of calcium in the bone. Osteoporosis often results in pain in the spine and other bones and is associated with increased risk of bone fractures. This disease is characterized by the rapid and widespread loss of bone mass and the thinning of the skeleton. This can occur in old age, resulting in fractures, and in pregnancy or in people having taken bisphosphonates for treating or preventing bone loss.

Unverified Answer

What is the average age someone gets osteoporosis?

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Findings from a recent study confirms the high prevalence of osteoporosis among women aged 50 to 60 years. The highest burden of osteoporosis in the study setting was in the urban area as the prevalence was as high as 22%. Findings from a recent study obtained from the two studies showed that the peak rate of osteoporosis among men is between the ages of 45 and 60 years of age. This is similar to what was reported by some studies. But the age of men with osteoporosis is not as high as in women. This may be due to male and female osteoporotic patients being diagnosed with osteoporosis at different times.

Unverified Answer

What are the latest developments in soluble corn fiber (scf) + calcium for therapeutic use?

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Results from a recent clinical trial of this study indicate the therapeutic benefits of adding scf + calcium to the diets of rats that have been induced into the metabolic syndrome without causing a high rate of loss of weight, or loss of any of the benefits attributed to scf in the treatment of obesity.

Unverified Answer

Have there been other clinical trials involving soluble corn fiber (scf) + calcium?

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To our knowledge, this is the first study to compare the safety and efficacy of scf + calcium to placebo + calcium by using a rigorous randomized design.

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Have there been any new discoveries for treating osteoporosis?

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In addition to medications, diet, and lifestyle changes, new discoveries have been made that may play a role in curing osteoporosis. This article will list some of these new discoveries and explain what they are.

Unverified Answer

Is soluble corn fiber (scf) + calcium typically used in combination with any other treatments?

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It does not appear that the addition of scf + calcium is routinely used in patients’ treatment of osteoporosis. The evidence is limited and further studies are warranted to confirm and expand these conclusions.

Unverified Answer

How does soluble corn fiber (scf) + calcium work?

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The study has shown that soluble maize fiber/calcium supplements in the form of a tablet provided the greatest gain in both bone density and bone mineral and mineral content, although it is essential to note that this type of treatment may be appropriate in other countries where scf/calcium supplements do exist that might be formulated as a tablet.

Unverified Answer
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