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

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

Sponsors

Lead Sponsor: Columbia University

Collaborator: University of California, Irvine
Osteoporosis Center of Armenia

Source Columbia University
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.

Overall Status Recruiting
Start Date February 5, 2020
Completion Date December 31, 2022
Primary Completion Date December 31, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean change in bone mineral density (BMD) (lumbar spine) 48 weeks
Mean change in BMD (femoral neck) 48 weeks
Mean change in BMD (total hip) 48 weeks
Mean change in BMD (forearm) 48 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Coral Complex 3

Description: Coral-derived calcium supplement fortified with vitamin D3

Intervention Type: Drug

Intervention Name: Ibandronate

Description: Bisphosphonate

Intervention Type: Dietary Supplement

Intervention Name: Vitamin D3

Description: Oral vitamin D3

Arm Group Label: Ibandronate and vitamin D

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.

Gender: Female

Minimum Age: 50 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
John P Bilezikian, MD, PhD Principal Investigator Columbia University
Overall Contact

Last Name: Nicholas Hutchings, MD

Phone: +1.203.747.6726

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Osteoporosis Center of Armenia Nicholas Hutchings, MD +1.203.747.6726 [email protected] John P Bilezikian, MD, PhD Principal Investigator Sisak Baghdasaryan, MD, MPH Sub-Investigator Mushegh Kefoyan, MD, MPH Sub-Investigator
Location Countries

Armenia

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Columbia University

Investigator Full Name: John P. Bilezikian

Investigator Title: Dorothy L. and Daniel H. Silberberg Professor of Medicine and Professor of Pharmacology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Coral calcium complex and ibandronate

Type: Active Comparator

Label: Ibandronate and vitamin D

Type: Active Comparator

Label: Coral calcium complex

Type: Active Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov