Clinical trial: Stem Cell Recruitment in Osteoporosis Therapy (NCT01656629)

Eligibility criteria:
Inclusion Criteria:

          -  Post-menopausal women aged 50-80 years

          -  T score < -2.5 at lumbar spine, total hip or femoral neck on dual x-ray absorptiometry
             (DXA) OR T score < -1.5 with a personal or family history of fracture

        Exclusion Criteria:

          -  Previous use of bisphosphonates or Teriparatide; current estrogen therapy; any other
             osteoporosis therapy in the past 6 months

          -  Metabolic bone disease other than osteoporosis

          -  Body mass index (BMI) < 18

          -  Weight > 325 lbs

          -  Current smoking or current alcohol use that exceeds 3 units of alcohol daily

          -  Use of medications known to affect bone metabolism

          -  Renal disease, history of kidney stones or hypercalciuria

          -  Hypo- or hyperparathyroidism; hypo- or hypercalcemia

          -  Serum vitamin D level < 20 ng/dL

          -  Refusal to adjust their dietary calcium to <750mg (i.e. two servings per day of
             calcium rich food)

          -  History of bone marrow or organ transplant

          -  History of malignancy or radiation to the bone

          -  History of esophageal stricture, dysmotility or severe reflux disease

          -  Gastrointestinal malabsorption

          -  Use of digoxin

          -  Need for chronic anticoagulation therapy such as Coumadin, heparin or low molecular
             weight heparin or inability to discontinue anti-platelet medication

          -  Bleeding diathesis; hemoglobin ≤ 12.5 g/dL (American Red Cross cut-off to donate
             blood)

          -  International normalized ratio (INR) pro time > 1.1 or activated partial
             thromboplastin time (APT) T ratio > 1.2

          -  Platelets < 150K/cu mm

          -  Cellulitis at site of iliac crest

          -  History of allergy to medications used in bone biopsy (demeclocycline, lidocaine)

          -  Inability to understand and provide informed consent.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 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