Clinical trial: Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis (NCT01753856)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory, postmenopausal women (no vaginal bleeding for at least 2 years prior to
             screening) with osteoporosis

          -  Bone mineral density (BMD) T-score of at least -2.5 at femoral neck (FN), total hip
             (TH), or lumbar spine (LS) (Lumbar vertebrae L1-L4, with at least 2 evaluable
             vertebrae), with or without atraumatic fracture after menopause, OR

          -  BMD T-score of at least -1.5 at FN, TH, or LS (L1-L4, with at least 2 evaluable
             vertebrae), and 1 or more atraumatic fractures after menopause (vertebral or
             nonvertebral). Nonvertebral fracture sites allowed are wrist, hip, pelvis, rib,
             humerus, clavicle, leg (femur, tibia, and fibula, excluding ankle)

          -  Laboratory values for serum calcium, parathyroid hormone (PTH), and alkaline
             phosphatase must be within the normal reference range

        Exclusion Criteria:

          -  Has an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of
             bone, a previous bone tumor, or radiation involving the skeleton

          -  Has an allergy or intolerance to teriparatide or denosumab and/or is a poor candidate
             for teriparatide or denosumab treatment (investigator should refer to local product
             prescribing information)

          -  Has a history of exposure to DEM or TET therapy in the 12 months prior to screening or
             a known allergy to DEM or TET

          -  Has a condition that could put the participant at additional risk of an adverse event
             (AE) due to the bone biopsy procedure (for example, bleeding disorder)

          -  Has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest)

          -  Has a 25-hydroxyvitamin D concentration of <10 nanograms per milliliter (ng/mL)

          -  Has currently active or suspected (within 1 year prior to enrollment) diseases that
             affect bone metabolism, other than osteoporosis (such as renal osteodystrophy,
             hyperthyroidism, osteomalacia, or hyperparathyroidism)

          -  Has a history of certain cancers within 5 years prior to trial entry

          -  Current or recent (within 1 year prior to enrollment) celiac disease, inflammatory
             bowel disease, gastric bypass, or other malabsorption syndrome

          -  Has significantly impaired hepatic or renal function

          -  Has had treatment with systemic glucocorticoids in doses ≥5 mg/day prednisone/day or
             equivalent in the 6 calendar months prior to screening

          -  Has taken any intravenous osteoporosis medication

          -  Has had prior treatment with other bisphosphonates and not been off of them for a
             specific period of time before trial entry

          -  Has participated in any other clinical trial studying teriparatide, PTH, PTH analog,
             or denosumab, or prior or current treatment with teriparatide, PTH, PTH analog, or
             denosumab
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 89 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? 1