EUCTR2006-006015-72-DKActive, not recruitingNot Applicable
Study CR9108963: A Dose-Range Finding Study of SB-751689 in Post-Menopausal Women with Osteoporosis
GlaxoSmithkline Research and Development Ltd0 sites520 target enrollmentStarted: March 20, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 520
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Informed consent: Subject is willing and able to provide written informed consent.
- •2. Menopausal status: Ambulatory female aged < 80 years at screening and >5 years postmenopausal, which can be >5 years of spontaneous amenorrhea or > 5 years post surgical bilateral oophorectomy. Use follicle stimulating hormone [FSH] levels >40 mIU/mL to confirm surgical postmenopausal status, where bilateral oophorectomy status is uncertain.
- •3. 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.
- •Fracture is defined as having a 20% reduction in anterior, middle or posterior vertebral height determined by semi-quantitative DXA examination at the site.
- •4. Suitable vertebra: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA.
- •5. Protocol compliance: Subject who, in the opinion of the investigator, is willing and able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. 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.
- •2. Vertebral fractures: Has >1 prevalent vertebral fracture at the screening visit (where fracture is defined as having a 20% reduction in anterior, middle or posterior vertebral height determined by semi-quantitative DXA examination at the site).
- •3. Non-vertebral fractures: Any previous non-vertebral osteoporosis related/fragility fracture after age 40.
- •4. 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 [e.g., human immunodeficiency virus (HIV) infection, chronic hepatitis B and C (as evidenced by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody), significant mental illness].
- •5. 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.
- •6. 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).
- •7. QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval =450 msec on the Screening ECG).
- •8. Torsades de Pointes: A history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- •9. Liver chemistries: Liver chemistries [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase or total bilirubin] exceeding 2-fold the upper limit of the laboratory-specified reference range, at screening.
- •10. Abnormal serum calcium: Serum calcium (total or albumin-adjusted) outside the central laboratory reference range at the screening visit.
- •11. Abnormal PTH: PTH (intact and whole) outside the normal range.
- •12. 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.
- •13. 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 an
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