Clinical trial: Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures (NCT01482858)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoporotic patients aged 18-80 years old, inclusive.

          -  Diagnosed Osteoporotic vertebral compression fracture(s) in at least one vertebra
             caused by an atraumatic event or a minimal traumatic event such as falling from
             standing height or less, or by other minimal trauma besides a fall (see section 4.2
             Table I for definitions), and visible by either X-ray radiography, CT or MRI.

          -  At least six (6) weeks and no more than six (6) months from the onset of severe back
             pain suspected to be caused by the OVCF.

          -  Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).

          -  Subjects able to adhere to the visit schedule and protocol requirements and be
             available to complete the study.

          -  Subject that had signed the ICF.

        Exclusion Criteria:

          -  More than six (6) months from the onset of severe back pain suspected to be caused by
             OVCF.Subjects after vertebroplasty or kyphoplasty.

          -  Hypercalcemic subjects (calcium > 10.50 mg/dL).

          -  Subjects with renal diseases.

          -  Subjects with active malignancy or other active metabolic bone disease which is not
             osteoporosis.

          -  Subjects with cognitive impairments.

          -  Pregnant or breastfeeding women.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 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? Entailment