Clinical trial: A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women (NCT00959764)

Eligibility criteria:
Inclusion Criteria:

          -  Female and age 45 or over.

          -  Must have undergone the onset of spontaneous or surgical menopause. Spontaneous
             menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous
             amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40
             milli-international units (mIU)/milliliter (mL) or 6 weeks post-surgical bilateral
             oophorectomy with or without hysterectomy.

          -  Diagnosis of osteoporosis on the basis of an axial lumbar spine, femoral neck or total
             hip BMD which is below the mean for premenopausal women by a magnitude of at least 2.5
             SD or 2.0 SD, if there is a documented history of a vertebral fragility fracture.

          -  Must have at least three contiguous lumbar vertebrae (L1-L4) that are evaluable by DXA
             for BMD that is, without fracture or significant degenerative disease, as determined
             by Bio-Imaging Technologies, Inc.

          -  No clinically significant abnormal findings in the medical history, physical exam or
             nasal exam.

          -  No clinically significant abnormal laboratory values at the screening assessment.

        Exclusion Criteria:

          -  History of severe allergic disease.

          -  History of metabolic and other bone diseases, including osteogenesis imperfecta,
             osteomalacia, and Paget's disease.

          -  Vitamin D insufficiency defined as a 25 hydroxyvitamin D level <20 ng/mL.

          -  Use of any intravenous bisphosphonate in the past 24 months, or >2 doses of
             intravenous bisphosphonate ever.

          -  Use of oral bisphosphonate before randomization, including investigational
             bisphosphonates, unless: 1) less than 6 months of treatment and off for 6 months, or
             2) 6 to 12 months of treatment and off for 2 years, or 3) More than 12 months of
             treatment and off for 5 years

          -  Use of denosumab, fluoride, or strontium, ever.

          -  Use of parathyroid hormone analogs or other bone metabolic agents within 1 year
             preceding randomization.

          -  Any condition or disease that may interfere with the ability to have a DXA scan or to
             evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion,
             pedicle screws, history of vertebroplasty, or degenerative disease that results in
             insufficient number of evaluable lumbar vertebrae, or more than 1 lumbar vertebral
             fracture in L1 through L4. (More than 4 vertebral fractures in T4 through L4;
             Bilateral hip replacements)

          -  Use of anabolic steroids or androgens within 6 months preceding randomization.

          -  Use of Vitamin D metabolites and analogs, (e.g., calcitriol) within 3 months preceding
             randomization). Note: Vitamin D supplementation is not exclusionary.

          -  Use of estrogen or estrogen-related drugs, for example, tamoxifen, tibolone, or
             raloxifene within 3 months preceding randomization.

          -  Use of coumadin within 4 weeks preceding randomization or heparin within 1 week
             preceding randomization.

          -  Chronic systemic treatment with glucocorticoids, hormone replacement therapy,
             calcitonin or any other medication within the previous three months which, in the
             opinion of the Investigator, would interfere with the study.

          -  Clinically relevant abnormal history, physical findings or laboratory values at the
             pre-study screening assessment that could interfere with the objectives of the study
             or the safety of the patient.

          -  Presence of acute or chronic illness or history of chronic illness which, in the
             judgment of the Investigator, makes participation in the study medically
             inappropriate.

          -  Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled
             diabetes mellitus, significant coronary heart disease, any psychotic mental illness,
             chronic allergic rhinitis, asthma, uncorrected endocrine dysfunction, or significantly
             impaired hepatic, respiratory or renal function.

          -  History of drug or alcohol abuse, or intake of more than 30 units of alcohol weekly.
Female
No healthy subjects accepted to join the trial.
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? 1