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Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

Primary Purpose

Osteoporosis, Postmenopausal

Status

Unknown status

Phase

Phase 2

Locations

Armenia

Study Type

Interventional

Intervention

Coral Complex 3

Ibandronate

Vitamin D3

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring Calcium, Coral calcium, Ibandronate

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year.
BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm < -2.5 as determined by DXA.

Exclusion Criteria:

T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm < -3.5.
Use of any supplemental calcium preparations in the past 1 year.
Use of ibandronate in the past 3 years.
Current use of
1. prednisone or other corticosteroid,
2. antiseizure medications,
3. thiazide diuretics, or
4. estrogen preparation except vaginal cream.
Electrolyte abnormalities, as defined by abnormal blood levels of sodium (Na), chlorine (Cl), potassium (K), phosphate (Phos), calcium (Ca), or magnesium (Mg) values on initial screen.
Chronic disease, including
1. liver disease (as defined by elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and/or alkaline phosphatase or reduced albumin or total protein on initial screen),
2. stage III renal disease or worse (as defined by epidermal growth factor receptor (eGFR) < 60 cc/min),
3. abnormal thyroid function tests,
4. current parathyroid disease (as defined by hypercalcemia and elevated levels of parathyroid hormone (PTH) - if history of hyperparathyroidism, surgical cure has to be documented more than 5 years ago),
5. diabetes mellitus,
6. any other known metabolic bone disease besides osteoporosis, and/or
7. any inflammatory, anatomic, or malabsorptive GI tract disease.
Osteoporotic fracture in the past 6 months, defined as a low-energy fracture such as a fracture after falling from a standing height.

Sites / Locations

Osteoporosis Center of ArmeniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Coral calcium complex and ibandronate

Ibandronate and vitamin D

Coral calcium complex

Arm Description

Outcomes

Primary Outcome Measures

Mean change in bone mineral density (BMD) (lumbar spine)

Participant bone mineral density of lumbar spine.

Mean change in BMD (femoral neck)

Participant bone mineral density of femoral neck.

Mean change in BMD (total hip)

Participant bone mineral density of total hip.

Mean change in BMD (forearm)

Participant bone mineral density of forearm.

Secondary Outcome Measures

Full Information

NCT ID

NCT04321837

First Posted

March 23, 2020

Last Updated

March 24, 2020

Sponsor

Columbia University

Collaborators

University of California, Irvine, Osteoporosis Center of Armenia

1. Study Identification

Unique Protocol Identification Number

NCT04321837

Brief Title

Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

Official Title

Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 5, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

University of California, Irvine, Osteoporosis Center of Armenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate the effect of coral calcium complex supplementation on BMD of osteoporotic individuals either when used alone or in combination with ibandronate. Ibandronate alone will also be tested in comparison to coral calcium supplementation alone or in combination.

Detailed Description

Osteoporosis and resulting fragility fractures are major causes of morbidity and mortality in older individuals. Current estimates indicate that as many as 50% of American women and 20% of men over the age of 50 will be at risk for osteoporotic fractures during their lifetimes, and that these fractures are associated both with higher risk for further fractures and with higher mortality rates. Osteoporosis and subsequent fragility fractures can be prevented if diagnosed and treated appropriately. The first step of treatment guidelines for individuals with reduced bone mineral density (BMD), as identified with dual energy x-ray absorptiometry (DXA) scan, is the implementation of lifestyle measures to reduce bone loss. These include the supplementation of dietary calcium and vitamin D to maintain appropriate calcium intake and reduce resorption of mineralized calcium from bone. Pharmacological treatment can be used for the treatment of osteoporosis in individuals who have reduced BMD (less than -2.5 T-score) and for those who have sustained a fragility fracture. The bisphosphonates are first line agents for the treatment of osteoporosis. Coral-derived calcium is a novel formulation of calcium supplement, which has not yet been rigorously investigated as an efficacious nutrient for the skeleton. Ibandronate is a commonly available bisphosphonate prescribed for the treatment of osteoporosis. Vitamin D is a nutrient required to absorb vitamin D from the diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Postmenopausal

Keywords

Calcium, Coral calcium, Ibandronate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coral calcium complex and ibandronate

Arm Type

Active Comparator

Arm Title

Ibandronate and vitamin D

Arm Type

Active Comparator

Arm Title

Coral calcium complex

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Coral Complex 3

Intervention Description

Coral-derived calcium supplement fortified with vitamin D3

Intervention Type

Drug

Intervention Name(s)

Ibandronate

Intervention Description

Bisphosphonate

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

Oral vitamin D3

Primary Outcome Measure Information:

Title

Mean change in bone mineral density (BMD) (lumbar spine)

Description

Participant bone mineral density of lumbar spine.

Time Frame

48 weeks

Title

Mean change in BMD (femoral neck)

Description

Participant bone mineral density of femoral neck.

Time Frame

48 weeks

Title

Mean change in BMD (total hip)

Description

Participant bone mineral density of total hip.

Time Frame

48 weeks

Title

Mean change in BMD (forearm)

Description

Participant bone mineral density of forearm.

Time Frame

48 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year. BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm < -2.5 as determined by DXA. Exclusion Criteria: T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm < -3.5. Use of any supplemental calcium preparations in the past 1 year. Use of ibandronate in the past 3 years. Current use of prednisone or other corticosteroid, antiseizure medications, thiazide diuretics, or estrogen preparation except vaginal cream. Electrolyte abnormalities, as defined by abnormal blood levels of sodium (Na), chlorine (Cl), potassium (K), phosphate (Phos), calcium (Ca), or magnesium (Mg) values on initial screen. Chronic disease, including liver disease (as defined by elevated blood levels of aspartate aminotransferase, alanine aminotransferase, and/or alkaline phosphatase or reduced albumin or total protein on initial screen), stage III renal disease or worse (as defined by epidermal growth factor receptor (eGFR) < 60 cc/min), abnormal thyroid function tests, current parathyroid disease (as defined by hypercalcemia and elevated levels of parathyroid hormone (PTH) - if history of hyperparathyroidism, surgical cure has to be documented more than 5 years ago), diabetes mellitus, any other known metabolic bone disease besides osteoporosis, and/or any inflammatory, anatomic, or malabsorptive GI tract disease. Osteoporotic fracture in the past 6 months, defined as a low-energy fracture such as a fracture after falling from a standing height.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicholas Hutchings, MD

Phone

+1.203.747.6726

nicholas.hutchings@uci.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Bilezikian, MD, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Osteoporosis Center of Armenia

City

Yerevan

Country

Armenia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicholas Hutchings, MD

Phone

+1.203.747.6726

nicholas.hutchings@uci.edu

First Name & Middle Initial & Last Name & Degree

Varta Babalyan, MD

Phone

+374.91.411.863

vartababalyan@gmail.com

First Name & Middle Initial & Last Name & Degree

John P Bilezikian, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sisak Baghdasaryan, MD, MPH

First Name & Middle Initial & Last Name & Degree

Mushegh Kefoyan, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD

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Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate

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