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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Dietary supplement: Coral Complex 3; Drug: Ibandronate; Dietary supplement: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • Osteoporosis Center of Armenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coral calcium complex and ibandronate	Dietary supplement: Coral Complex 3; Coral-derived calcium supplement fortified with vitamin D3; Drug: Ibandronate; Bisphosphonate
Active Comparator: Ibandronate and vitamin D	Drug: Ibandronate; Bisphosphonate; Dietary supplement: Vitamin D3; Oral vitamin D3
Active Comparator: Coral calcium complex	Dietary supplement: Coral Complex 3; Coral-derived calcium supplement fortified with vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in bone mineral density (BMD) (lumbar spine)	Participant bone mineral density of lumbar spine.	48 weeks
Mean change in BMD (femoral neck)	Participant bone mineral density of femoral neck.	48 weeks
Mean change in BMD (total hip)	Participant bone mineral density of total hip.	48 weeks
Mean change in BMD (forearm)	Participant bone mineral density of forearm.	48 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: University of California, Irvine; Osteoporosis Center of Armenia
• Investigators: Principal Investigator: John P Bilezikian, MD, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): March 13, 2023
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Calcium; Ibandronate; Coral calcium
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ibandronic Acid
• Other Study ID Numbers: AAAS2051; HS# 2018-4772 (Other Identifier: University of California, Irvine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No