Status:
COMPLETED
Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate
Lead Sponsor:
Columbia University
Collaborating Sponsors:
University of California, Irvine
Osteoporosis Center of Armenia
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50-75 years
Phase:
PHASE2
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 als...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04321837
Start Date
February 5 2020
End Date
March 13 2023
Last Update
May 9 2024
Active Locations (1)
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1
Osteoporosis Center of Armenia
Yerevan, Armenia