A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) (Double-Blinded for 2 Different Dosages) in Comparison to Subcutaneous Injection of Forteo® Following 3-Month Treatment in Postmenopausal Women with Osteoporosis

• Conditions: The population for this study is post-menopausal, osteoporosis-treatment naïve women, 55 years of age to 85 years of age, inclusive, with a lumbar vertebral BMD T-score of below or equal to -2.5.

• Registration Number: EUCTR2007-004633-41-CZ
• Lead Sponsor: TransPharma Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Female subjects; 2. Age 55 to 85 years old, inclusive, at the time of dosing with study drug; 3. Determined to be postmenopausal, defined as: • No menstrual periods >36 consecutive months before the study; or • Surgical menopause >36 months (bilateral oophorectomy with or without hysterectomy) before the study and a serum follicle-stimulating hormone (FSH) level 30 mIU/mL; 4. Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA -2.5 SD at screening. 5. Have serum 25-OH D (25-dihydroxyvitamin D) level of >20 ng/mL at Screening Visit 1; If serum 25-OH D is =20 ng/mL, patients may be given vitamin D supplements and re-tested 4 to 12 weeks later; 6. Have normal serum PTH at screening visit 1 (test acceptable up to 6months prior to screening), and thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone); 7. Have the following values: • Serum total calcium <10.3 mg/dL; • Serum creatinine <1.6 mg/dL; • Phosphate > 2.5mg/dL; • AST and ALT <2x the upper limit of normal; • Total bilirubin <2 mg/dL; • Alkaline phosphatase <150 U/L; • Hemoglobin >11 gm/dL; • White blood cell count >4000x109; • Platelet count >100,000 x109/L; • 24-hour urine calcium <300 mg/day; • Urine creatinine >500 mg/day; 8. Able to understand and provide written informed consent before any study procedures take place; 9. Able to be reached by telephone for follow-up contact between visits.
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

1. Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include the conditions listed below, as determined by medical history, physical examination, laboratory tests or ECG. • Cushing’s disease; • Osteogenesis imperfecta; • Known blood disorders; • Any kidney stone within the past 5 years, or multiple prior kidney stones; • Impaired renal function (creatinine clearance [CrCl] <30 mL/min); • Active hepatitis; • Active pancreatitis; • Unstable pulmonary disease; • Uncontrolled Celiac disease; • Severe unstable symptomatic vascular disease; • Active Inflammatory bowel syndrome; • Seizure disorders treated with phenobarbital or phenytoin; • Any other previous or ongoing clinically significant illness, including any neurological or psychiatric disease, that would interfere with the patient’s ability to comply with the study protocol or could prevent the patient from completing the study; 2. Patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, or prior external beam or implant radiation therapy involving the skeleton); 3. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease 4. Use of a pacemaker; 5. Clinically and symptomatically diagnosed with bone fracture in the last 6 months, excluding fracture in finger and/or tow; 6. Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan, for example: • Severe osteoarthritis of the spine; • Spinal fusion; • Pedicle screws; • History of vertebroplasty; and • Degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or >2 lumbar vertebral fractures; 7. Alcohol abuse within 2 years; 8. Drug abuse (prescribed and non-prescribed) in the past 2 years; 9. History of cancer that includes any cancer within the previous 5 years, except squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for =1 year from the time of original resection; 10. Have a past history of ionizing radiation in therapeutic (not diagnostic) doses that include bone; 11. Blood donation within 4 weeks prior to the start of dosing or plasma donation within 7 days of dosing; 12. Prior osteoporosis treatment with fluoride or strontium at any time; 13. Have received any intravenous (IV) administration bisphosphonates in the past; 14. Have received treatment with oral bisphosphonate for more than 1 month (accumulated in total) in the past 24 months prior to randomization (Bisphosphonates are including, but not limited to, alendronate, risedronate, ibandronate, tiludronate, clodronate, pamidronate, and etidronate, zoledronate, ibandronate, etidronate); 15. Have not had a washout period of at least 3 times the duration of the treatment received with oral bisphosphonates prior to randomization; 16. Use of the following therapies for the specified times before randomization in this study; • Any investigational drug within 60 days; • Anabolic steroids or androgens within 6 months; • Vitamin D metabolites and analogs, e.g., calcitrol, within 90 days; • Daily inhaled corticosteroids of beclomethasone 1200 µg/day or equiv

Study & Design

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