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

NCT ID: NCT04321837

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2023-03-13

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.

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coral calcium complex and ibandronate

Group Type: ACTIVE_COMPARATOR

Coral Complex 3

Intervention Type: DIETARY_SUPPLEMENT

Coral-derived calcium supplement fortified with vitamin D3

Ibandronate

Intervention Type: DRUG

Bisphosphonate

Ibandronate and vitamin D

Group Type: ACTIVE_COMPARATOR

Ibandronate

Intervention Type: DRUG

Bisphosphonate

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Oral vitamin D3

Coral calcium complex

Group Type: ACTIVE_COMPARATOR

Coral Complex 3

Intervention Type: DIETARY_SUPPLEMENT

Coral-derived calcium supplement fortified with vitamin D3

Interventions

Coral Complex 3

Coral-derived calcium supplement fortified with vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Ibandronate

Bisphosphonate

Intervention Type: DRUG

Vitamin D3

Oral vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Postmenopausal women, 50-75 years of age (inclusive). Menopause is defined as no menstrual period for 1 year.

2. BMD T-score of lumbar spine (L1-L4), femoral neck, total hip, or non-dominant forearm < -2.5 as determined by DXA.

Exclusion Criteria

1. T-score of lumbar spine, femoral neck, total hip, or non-dominant forearm < -3.5.

2. Use of any supplemental calcium preparations in the past 1 year.

3. Use of ibandronate in the past 3 years.

4. Current use of

1. prednisone or other corticosteroid,

2. antiseizure medications,

3. thiazide diuretics, or

4. estrogen preparation except vaginal cream.

5. 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.

6. 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.

7. Osteoporotic fracture in the past 6 months, defined as a low-energy fracture such as a fracture after falling from a standing height.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

Osteoporosis Center of Armenia

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

John P. Bilezikian

Dorothy L. and Daniel H. Silberberg Professor of Medicine and Professor of Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John P Bilezikian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Osteoporosis Center of Armenia

Yerevan, , Armenia

Countries

Armenia

Other Identifiers

HS# 2018-4772

Identifier Type: OTHER

Identifier Source: secondary_id

AAAS2051

Identifier Type: -

Identifier Source: org_study_id