Clinical trial: A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis. (NCT00471237)

Eligibility criteria:
Inclusion:

          -  Informed consent: Subject is willing and able to provide written informed consent.

          -  Menopausal status: Ambulatory female aged < 80 years at screening and >5 years
             postmenopausal.

          -  T-Score: A subject with either no or only one prevalent vertebral fracture is eligible
             for inclusion if she satisfies one of the following T-score requirements:

        If no prevalent vertebral fracture subject must have an absolute BMD value consistent with
        a T-score of less than or equal to -2.5 and greater than -4.0 at either the femoral neck,
        total hip, trochanter, or lumbar spine, or If one prevalent vertebral fracture subject must
        have an absolute BMD value consistent with a T-score of less than or equal to -2.0 and
        greater than -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.

          -  Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for
             BMD measurement by DXA.

          -  Protocol compliance: Subject who, in the opinion of the investigator, is willing and
             able to comply with the requirements of the protocol.

        Exclusion:

          -  T-Score: Has an absolute BMD value consistent with a T-score less than or equal to
             -4.0 at either the femoral neck, total hip, trochanter, or lumbar spine.

          -  Vertebral fractures: Has >1 prevalent vertebral fracture at the screening visit.

          -  Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility
             fracture after age 40.

          -  Spine deformity: Significant spine deformity which would preclude DXA/QCT assessments.

          -  BMI: BMI ≥33kg/m2.

          -  Bone metabolic diseases: Other than osteoporosis, history or concurrent diseases
             affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism).

          -  GI disease: History of major upper gastrointestinal disease

          -  Malabsorption: Active or history of malabsorption (e.g., history of celiac disease,
             irritable bowel syndrome or inflammatory bowel disease).

          -  Liver disease: Past or current history of liver disease or known hepatic or biliary
             abnormalities, (with the exception of previously documented diagnosis of Gilbert's
             syndrome).

          -  Rheumatoid arthritis: Active disease or history of rheumatoid arthritis.

          -  Nephrolithiasis: History of or active nephrolithiasis (kidney stones).

          -  Osteosarcoma risk: Subjects at increased risk of osteosarcoma such as those with
             Paget's disease of bone or any prior external beam or implant radiation therapy
             involving the skeleton.

          -  Malignancy: Malignant disease diagnosed within the previous 5 years (except resected
             basal cell cancer).

          -  Biological abnormalities: Any clinically relevant biological abnormality found and/or
             volunteered at screening (other than those related to the disease under investigation)
             which, in the opinion of the investigator, is clinically significant and would
             preclude safe participation in this study.

          -  Surgical and medical conditions: Presence of the following conditions within six
             months prior to screening: myocardial infarction, coronary bypass surgery, coronary
             artery angioplasty, unstable angina, cardiac arrhythmia, clinically evident congestive
             heart failure, or cerebrovascular accident.

          -  Glomerular filtration rate: Glomerular filtration rate (GFR) <35 mL/min as calculated
             by the Modification of Diet in Renal Disease (MDRD) equation as follows: GFR
             (mL/min/1.73 m2) = 186 x (Serum creatinine mg/dL)-1.154 x (Age)-0.203 x (0.742 if
             female) x (1.210 if African American) (conventional units).

          -  QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc
             interval ≥450 msec on the Screening ECG).

          -  Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart
             failure, hypokalemia, family history of Long QT Syndrome).

          -  Liver chemistries: Liver chemistries [aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) or total bilirubin] exceeding 2-fold the upper limit of the
             laboratory-specified reference range, at screening.

          -  Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central
             laboratory reference range at the screening visit.

          -  Abnormal PTH: PTH (intact or whole) outside the normal range.

          -  Abnormal creatine phosphokinase: Creatine phosphokinase (CPK) outside the normal
             range.

          -  Abnormal alkaline phosphatase: Alkaline phosphatase outside of the normal range.

          -  Thyroid hormone replacement: Subjects receiving thyroid hormone replacement therapy
             must have a TSH level checked. Subjects will be excluded if TSH levels are <0.1 or
             >10.0mIU/L. However, subjects will not be excluded if TSH is in the range 0.1-4.5
             mIU/L. If TSH is >4.5 and ≤10.0mIU/mL, measure T4 and exclude the subject only if the
             T4 is outside the normal range.

          -  Vitamin D deficiency: Vitamin D deficiency (serum 25-hydroxy vitamin D < 20ng/mL,
             equivalent to 50nmol/L) at screening. Subjects can undergo vitamin D repletion as per
             local practice and be re-screened once only for vitamin D levels within the 6-week
             screening period. They will remain excluded if the re-screened value is < 20ng/mL.

          -  Previous strontium or IV bisphosphonate: Any previous treatment with strontium
             ranelate or intravenous bisphosphonate.

          -  Oral bisphosphonates: Any previous treatment with an oral bisphosphonate as follows:

        any treatment within the last six months

          -  one month cumulative treatment within the last 12 months

          -  three months cumulative treatment within the past two years, or

          -  two years cumulative treatment within the past five years.

               -  Fluoride: Treatment with fluoride (dose greater than 10mg/day) within the
                  previous 5 years for osteoporosis.

               -  Digoxin: Current therapy with digoxin.

               -  Bone metabolism drugs: Treatment with other drugs affecting bone metabolism
                  within the last six months prior to screening:

        Chronic systemic corticosteroid [e.g., glucocorticoid, mineralocorticoid] treatment of no
        more than 2 intra-articular injections within the past year or use of oral, parenteral, or
        long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid
        will not exclude the subject from participating.

        Hormones [e.g., estrogens/"natural estrogen preparations"(except for nonsystemic vaginal
        treatment), 19-norprogestins, SERMs such as raloxifene, anabolic steroids/androgens such as
        dehydroepiandrosterone (DHEA) or its sulfated form (DHEAS), nandrolone, tibolone, active
        vitamin D analogs/metabolites such as 1,25-dihydroxy vitamin D (calcitriol) or
        1alpha-hydroxyvitamin D3 (1-alpha hydroxycholecalciferol), calcitonin].

        Calcineurin inhibitors [e.g., cyclosporine, tacrolimus] or methotrexate.

          -  Previous anabolic agents: Treatment with PTH, PTH analogues or similar anabolic agent
             for osteoporosis within the last two years.

          -  Contraindications: Contraindications to therapy with calcium or vitamin D.

          -  Pregnancy: Women who are pregnant are not allowed in this study.

          -  Interfering medications: Vitamin A in excess of 10,000 IU per day, heparin, or
             lithium, or anticonvulsant medications except benzodiazepines.

          -  Investigational drug exposure: Administration of any investigational drug within 90
             days preceding the first dose of the study drug.

          -  Substance abuse: History or current evidence of drug or alcohol abuse within the
             previous 12 months.

          -  Problems swallowing: Inability to swallow a tablet whole.

        The following exclusion criteria do not apply to subjects allocated to the open-label
        teriparatide group:

          -  Calcium channel blockers: Current therapy with calcium channel blockers diltiazem and
             verapamil.

          -  Oral Azole Antifungals: Current therapy with any oral azole antifungal.

          -  Immunosuppressants: Current therapy with cyclosporine or oral tacrolimus.

          -  Ritonavir: Current therapy with ritonavir.

          -  Quinidine: Current therapy with quinidine.

          -  Macrolide Antibiotics: Subjects anticipated to require chronic use of macrolide
             antibiotics.

          -  Alendronate Contraindications: Contraindications to therapy with alendronate.
             Additional Exclusion Criteria for Subjects Recruited at QCT Sites

          -  Hip surgery: History of hip surgery resulting in a metal implant on either the left or
             right side that would cause an artefact on a QCT scan.

        Additional Exclusion Criteria for Teriparatide Subjects

          -  Teriparatide contraindications: Contraindications to therapy with teriparatide
             according to locally approved datasheet.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 79 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