Clinical trial: The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab (NCT02130973)

Eligibility criteria:
Inclusion Criteria:Subjects should be postmenopausal >age 45, and of any racial origin.
        They must not be on any osteoporosis medication. They should be willing to participate for
        the duration of the study and have no physical or psychological illness that would prohibit
        them from participating. Pregnant women, protected individuals (institutionalized), and
        those unable to give informed consent will not be recruited. Exclusion criteria are
        detailed below.

        Subjects who meet initial pre-screening criteria will present for an on site screening
        visit and have a full medical history, brief physical exam, BMD and lab evaluation to
        confirm eligibility. Osteoporosis will be defined by DXA BMD T-Score < -2.5 at lumbar spine
        (at least 2 evaluable vertebrae between L1 and L4), or total hip or femoral neck. In
        addition, women with confirmed vertebral deformity on radiograph or lateral DXA image, or
        prior osteoporosis-related fracture at age >45 along with a DXA BMD T-Score < -1.5 at one
        or more skeletal sites will be eligible to participate.

        Exclusion Criteria:

          -  The use of drugs known to affect skeletal or calcium homeostasis.

          -  Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2
             evaluable lumbar vertebrae

          -  Current use of anti-resorptive medicines

               -  Use of Hormone/Estrogen Therapy, raloxifene or calcitonin within the past 3
                  months

               -  Use of oral bisphosphonate for more than 4 months within the past 2 years or more
                  than 5 years total cumulative bisphosphonate use in the past 10 years

               -  Use of intravenous ibandronate within the past 18 months

               -  Use of intravenous zoledronic acid within the past 4 years

               -  A history of a symptomatic renal stone within the past 3 years or history of
                  multiple symptomatic renal stones

               -  Skeletal Disorders other than osteoporosis including: Hypercalcemia,
                  hyperparathyroidism, Paget's Disease or osteomalacia

               -  Untreated or uncontrolled thyroid disease

               -  Elevated Bone Specific Alkaline Phosphatase level

               -  History of external or internal radiation therapy

               -  Renal insufficiency with estimated GFR below 30 ml/min

               -  Liver function tests (ALT/AST) more than 1.5 times the upper limit of normal

               -  Clinically significant hyperuricemia or active gout

               -  Any contraindications to receipt of Teriparatide or Denosumab (including
                  hypocalcemia)

               -  History of an atypical fracture of the femoral shaft
Female
Accepts Healthy Volunteers
Subject must be at least 45 Years old.


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