Study CR9108963: A Dose-Range Finding Study of SB-751689 in Post-Menopausal Women with Osteoporosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 0

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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