Clinical trial: A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001) (NCT00960934)

Eligibility criteria:
Inclusion Criteria:

          -  Postmenopausal for at least 5 years

          -  No history of fragility fracture, unless participant is not willing to take marketed
             osteoporosis therapy or is not a candidate for marketed osteoporosis therapy

          -  Agrees not to use medications for osteoporosis except medications associated with the
             study

          -  Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD
             sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD
             sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy
             may have one or more areal BMD T-scores of < -3.5

        Exclusion Criteria:

          -  Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie,
             weight >250 lbs)

          -  Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3
             months in the past 2 years, or lifetime use of more than 6 months

          -  Use of intravenous bisphosphonates, strontium, or growth hormone at any time

          -  Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within
             6 months prior to Visit 1

          -  Use of pioglitazone or rosiglitazone at study screening

          -  Use of estrogen ± progestin, in any form other than vaginal or topical application,
             for 6 months prior to Study Visit 1

          -  Prior total thyroidectomy

          -  Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome
             (AIDS)-related illness

          -  History of malignant cancer within 5 years of study screening, except for certain skin
             or cervical cancers

          -  History of Paget's disease and/or kidney stones

          -  An active user of any illicit drug

          -  History of or active alcohol abuse

          -  Participated in an investigational drug study within the past 30 days
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 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