Clinical trial: Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action (NCT01293292)

Eligibility criteria:
Inclusion Criteria

        Subjects must:

          -  Have a bone mineral density T-score (at the lumbar spine or total hip) of less than or
             equal to -2.5

          -  Be female

          -  Be at least 5 years post menopausal (more than 5 years since their last menstrual
             period) but <85 years old.

          -  Be ambulatory

          -  Be able and willing to participate in the study and provide written informed consent

          -  Have a serum 25(OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading)

        Exclusion Criteria

        Patients will not be admitted to the study if they exhibit any of the following:

          -  Evidence of a clinically significant organic disease which could prevent the patient
             from completing the study

          -  A body mass index less than 18 or greater than 35

          -  Abuse of alcohol or use illicit drugs (information obtained from medical history) or
             who consumed more than 4 servings of any alcoholic beverage one day prior to the visit
             (i.e., subjects who might be binge drinkers)

          -  Any history of cancer within the past 5 years excluding skin cancer non melanomas

          -  Any history of ongoing conditions or diseases known to cause abnormalities of calcium
             metabolism or skeletal health including Paget's disease of bone

          -  Chronic renal disease (as defined by an estimated glomerular filtration rate of ≤
             30mL/min)

          -  Acute or chronic hepatic disease

          -  Malabsorption syndromes

          -  Hyperthyroidism as manifested by TSH outside the lower limit of the normal range

          -  Hyperparathyroidism

          -  Hypocalcemia or hypercalcemia

          -  Osteomalacia

          -  Cushing's syndrome

          -  Current use of glucocorticoid therapy

          -  A corrected serum calcium less than 2.2 mmol/L and a PTH above 100 ng/L (that persists
             after testing and treatment for vitamin D deficiency)

          -  A history of any known condition that would interfere with the assessment of DXA at
             either lumbar spine or femoral neck

          -  Markedly abnormal clinical laboratory parameters that are assessed as clinically
             significant by the investigator

          -  Any previous use of bisphosphonate

          -  Use any of the following medications within 12 months of starting study drug

          -  Any fluoride with the exception of use for oral hygiene

          -  Strontium Ranelate

          -  Other bone agents (e.g. SERM, isoflavones, HRT)

          -  Participation in another clinical trial involving active therapy 3 months prior to
             enrolment

          -  Less than 5 years since menopause

          -  Bilateral fractures in the measurement regions (hip, tibia and forearm)

          -  Recent fracture within the last 12 months

          -  Prior radiation therapy which may involve the skeleton

          -  Hypersensitivity to teriparatide or any of its excipients

          -  Unexplained elevations of alkaline phosphatase

          -  Any known contraindication to the use of teriparatide
Female
No healthy subjects accepted to join the trial.

Subject must be at most 84 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? Contradiction