A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forteo in Postmenopausal Women with Osteoporosis

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 12.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2010-020342-98-DK
• Lead Sponsor: nigene Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

•Informed consent: Willing and able to sign written informed consent.
•Ambulatory postmenopausal women in good health. Menopausal status: Subject should be at least 5 years postmenopausal which can be >5 years of spontaneous amenorrhea or >5 years postsurgical bilateral oophorectomy. Use follicle stimulation hormone (FSH) levels >40 mIU/mL to confirm surgical postmenopausal status where bilateral oophorectomy status is uncertain.
•Age 45 years - 80 years
•BMD values:
•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.
T-Score Values
GE-Lunar BMD ValuesHologic BMD Values
T-ScoreL1-L4Total HipFemoral NeckL1-L4Total HipFemoral Neck
-2.00.9580.7680.8080.8270.7020.629
-2.50.9030.7080.7530.7720.6420.574

•Suitable vertebrae: Two or more vertebra in the range of L1 to L4 that are suitable for BMD measurement by DXA.
•No clinically significant abnormal findings in the medical history or physical examination
oNegative screen for Hepatitis B and C, HIV and drugs of abuse at screening.
•Laboratory values:
oTotal serum Ca, albumin-adjusted Ca, P, and Mg++ within normal range.
oNo clinically significant abnormal laboratory values at the screening assessment.

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

•BMI: BMI =33kg/m2
•Illnesses:
•Liver function: Known hepatic or biliary abnormalities including Gilbert's syndrome.
•Abnormal Liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin).
•Medical illness: 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.
•History of clinically significant cardiovascular disease and/or postural hypotension.
•QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc interval > 450 msec on the Screeing ECG.
•Torsades des Pointes: A history of risk factors for Torsades de Pointes(e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
•History of pancreatitis, osteosarcoma or kidney stones.
•Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled diabetes mellitus, any psychotic mental illness, uncorrected endocrine dysfunction, or significantly impaired respiratory or renal function.
•Medical conditions which might alter bone metabolism, including: hyperparathyroidism, hypoparathyroidism, hyperthyroidism, hypothyroidism, Paget's disease, myeloma, malabsorption, Cushing's syndrome, hypocalcemia, hypercalcemia, hypophosphatemia, hyperphosphatemia, hypomagnesemia, hypermagnesemia, osteopetrosis, osteomalacia, rheumatoid arthritis and recent (within one year) history of non-traumatic fracture or prolonged bed rest.
•History of musculoskeletal disease. However, subjects with conditions such as fibromyalgia, osteoarthritis, and degenerative disc disease may be enrolled at the discretion of the Investigator and Medical Monitor.
•History of cancer within 5 years of enrollment other than basal cell carcinoma.
•History of surgery within 60 days of enrollment.
•Evidence of alcohol or substance abuse that the Investigator believes would interfere with understanding or completing the study.
•Electrocardiogram: Any clinically relevant abnormality identified on the 12-lead surface electrocardiogram (ECG).
•Laboratory Findings: Albumin-adjusted serum calcium greater or less than the normal reference range of the analytical laboratory.
•Urine calcium greater than the normal reference range of the analytical laboratory
•PTH(1-84) greater than the normal reference range of the analytical laboratory.
•Abnormal Alkaline Phosphatase
•Vitamin D: Vitamin D insufficiency defined as a 25 hydroxyvitamin D level <15 ng/mL.
•DXA: 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 per prior medical history.
•Bilateral hip replacements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified