Clinical trial: Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate (NCT04321837)

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.
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? 0