A Double-Blinded Randomized Controlled CER Study of Changes in Bone Mineral Density, Blood Chemistries, Self-Reported Quality of Life and Compliance as a Function of Consuming Micronized Versus Non-micronized Calcium Carbonate
Sponsor study identifier
interventional
160
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine whether consuming calcium carbonate that has been micronized is more effective than the traditional form of calcium carbonate in maintaining or increasing bone mineral density in people who are currently taking bisphosphonates or other bone-health medications.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 8, 2013
Actual (reported)May 20, 2013
Actual (reported)September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from baseline in Bone Mineral Density as a measurement by Dual Energy X-ray Absorptiometry
Bone density scanning, also called dual-energy x-ray absorptiometry (DXA) or bone densitometry, is an enhanced form of x-ray technology that is used to measure bone mineral density. Imaging with x-rays involves exposing a part of the body to a small dose of ionizing radiation to produce pictures of the inside of the body. Benefits * DXA bone densitometry is a simple, quick and noninvasive procedure. * No anesthesia is required. * The amount of radiation used is extremely small-less than one-tenth the dose of a standard chest x-ray, and less than a day's exposure to natural radiation. * DXA bone density testing is the most accurate method available for the diagnosis of osteoporosis and is also considered an accurate estimate
0 and 183 days
Blood Chemistry Panel
0 and 183 days
Systolic and Diastolic blood pressure
0 and 183 days
Resting heart rate
0 and 183 days
Self-reported quality of life
0 and 183 days
Number of participants with adverse effects
up to 183 days
Subjects currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total amount of 500 mg of Micronized Calcium Carbonate and 800 IU Vitamin D3
Subjects currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total amount of 1000 mg of Non-Micronized Calcium Carbonate and 800 IU Vitamin D3.
Subjects currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate.
Integrative Health Technologies
San Antonio, Texas, 78209, United States
Gilbert R Kaats, PhD FACN
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
Sidney J Stohs, PhD
Dean Emeritus, Creighton University Health Sciences Center
First Submitted
May 8, 2013
First Posted
May 20, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Functional and Metabolic Effects of Fonte Fausta® Water on Bone and Muscle Health in Osteoporotic Patients
Subjects who are not currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total of 1000 mg of Non-Micronized Calcium Carbonate and 800 IU Vitamin D3.
Subjects who are not currently being treated with Bisphosphonates will replace any calcium they are currently taking with four Capsules/Day containing a total of 500 mg of Micronized Calcium Carbonate and 800 IU Vitamin D3
Subjects currently being treated with bisphosphonates will be administered 1000 mg non-micronized calcium carbonate. Subjects not currently being treated with bisphosphonates will be administered 1000 mg non- micronized calcium carbonate.
All subjects in the study cohort will be administered 800 IU Vitamin D3.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 25, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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