Clinical trial: PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis (NCT00005005)

Eligibility criteria:
Inclusion Criteria:

          -  Aged between 55 and 85 years

          -  Postmenopausal (have not had any menses in the last 5 years)

          -  Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the
             hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total
             hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip
             and have at least one of the following risk factors for fracture: (a) age > 65 years;
             (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal
             history of hip fracture

          -  Willing and able to self-administer daily injections

        Exclusion Criteria:

          -  Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more
             than 12 months in the last 2 years

          -  History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks)
             within the past 12 months

          -  History of rhPTH (recombinant human PTH) use

          -  Any major life-threatening illnesses

          -  Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or
             currently using insulin

          -  Vitamin D level < 15 nanograms/ml

          -  History of kidney disease (creatinine > 2.0 mg/dl)

          -  Renal insufficiency (creatinine clearance < 40 mg/min)

          -  Any history of kidney stones

          -  Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg

          -  History of hypercalcemia, sarcoidosis, or hyperparathyroidism

          -  History of active or treated tuberculosis or other granulomatous disorders

          -  History of breast cancer, melanoma, or hematologic malignancy that has required
             treatment within the last 10 years

          -  History of bone cancer or any other metabolic bone disease that has required treatment
             within the last 10 years

          -  History of any other nonskin cancer that has required treatment within the last 10
             years

          -  History of symptomatic esophageal reflux, achalasia or esophageal stricture

          -  Currently taking > 7.5 mg systemic prednisone or equivalent per day

          -  Currently using > two puffs, four times/day of inhaled steroids

          -  Currently taking anticoagulants or anticonvulsants

          -  Have used Calcitonin within the past 3 months

          -  Have used Raloxifene in the last 6 months or for more than 12 months in the last 2
             years

          -  Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2
             years

          -  Have used fluoride for at least a month within the past 5 years

          -  Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites

          -  Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L
Female
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 85 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