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 and Osteopenia

• Conditions: The population for this study is post-menopausal, osteoporosis-treatment naïve women and patients with osteopenia, 55 years of age to 85 years of age, inclusive, with a lumbar vertebral BMD T-score of ?-1.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-20
• 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 and a serum follicle-stimulating hormone (FSH) level ?30 mIU/mL; or
•Surgical menopause >36 months (bilateral oophorectomy with or without hysterectomy) before the study;
4.Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ?-1 SD at screening.
5.Have serum 25-OH D (25-dihydroxyvitamin D) level of >20 ng/mL at Screening Visit 1;
6.Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values. If serum 25-OH D is <20 ng/mL, or is above normal, patients may be given vitamin D supplements and re-tested 4 to 12 weeks later;
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 conditiond 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;
•Celiac disease;
•Vascular disease;
•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.Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
3.Use of a pacemaker;
4.Diagnosed significant bone fracture in the last 12 months (the IATEC Medical Monitor can allow exceptions for minor fractures that have been empirically shown not to raise serum indices of bone formation and resorption;
5.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;
6.Alcohol abuse within 2 years;
7.Drug abuse (prescribed and non-prescribed) in the past 2 years and/or a positive urine drug test;
8.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;
9.Have a past history of ionizing radiation in therapeutic (not diagnostic) doses that include bone;
10.Blood donation within 4 weeks prior to the start of dosing or plasma donation within 7 days of dosing;
11.Prior osteoporosis treatment with fluoride or strontium at any time;
12.Have received any intravenous (IV) administration bisphosphonates in the past 24 months, or >2 doses of IV administered bisphosphonates total;
13.Have received treatment with oral or parenteral bisphosphonate including, but not limited to, investigational bisphosphonates, alendronate, risedronate, ibandronate, tiludronate, clodronate, pamidronate, and etidronate, zoledronate, ibandronate, etidronate;
14.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 equivalent within 3 months;
•Calcitonin, oral glucocorticoids, or thyroxine in doses that suppress the patient’s serum TSH below the lower limit of the normal range;
•Lithium;
•Pharmacological doses of vitamin D (greater than 2,000 IU/day);
•Anticonvulsants;
•Estrogen (oral, vaginal, or cutaneous) or estrogen-re

Study & Design

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