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

Overview

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.

Full Title of Study: “Coral Calcium’s Effect on Bone Density in Postmenopausal Women With and Without Ibandronate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • Dietary Supplement: Coral Complex 3
    • Coral-derived calcium supplement fortified with vitamin D3
  • Drug: Ibandronate
    • Bisphosphonate
  • Dietary Supplement: Vitamin D3
    • Oral vitamin D3

Arms, Groups and Cohorts

  • Active Comparator: Coral calcium complex and ibandronate
  • Active Comparator: Ibandronate and vitamin D
  • Active Comparator: Coral calcium complex

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Collaborator
    • University of California, Irvine
  • Provider of Information About this Clinical Study
    • Principal Investigator: John P. Bilezikian, Dorothy L. and Daniel H. Silberberg Professor of Medicine and Professor of Pharmacology – Columbia University
  • Overall Official(s)
    • John P Bilezikian, MD, PhD, Principal Investigator, Columbia University
  • Overall Contact(s)
    • Nicholas Hutchings, MD, +1.203.747.6726, nicholas.hutchings@uci.edu

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