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

AAAS2051

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.

2020-02-05

2023-03-13

2023-03-13

Completed

Early phase I

60

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2024-05-09