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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    60
  • sponsor
    Columbia University
Updated on 24 January 2021
calcium
cholecalciferol
bisphosphonate
vitamins
bone mineral density
calcium supplementation
ibandronate

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.

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.

Details
Condition Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment Vitamin D3, Ibandronate, Coral Complex 3
Clinical Study IdentifierNCT04321837
SponsorColumbia University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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