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.
Conditions
Interventions
Product Name: ViaDerm-hPTH (1-34)
Pharmaceutical Form: Modified-release granules
Concentration unit: U unit(s)
Concentration type: up to
Concentration number: 80-mcg/patch
Trade Name: Forsteo
Produc
Sponsors
TransPharma Medical
Eligibility
Sex/Gender
All
Inclusion criteria
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 11 gm/dL; • White blood cell count >4000x109; • Platelet count >100,000 x109/L; • 24-hour urine calcium 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
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] 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •The change in procollagen 1 N-terminal Polypeptide (P1NP-1) from baseline to Day 96. ;Secondary Objective: • The change in CTX-1 from baseline to Day 96. • Repeated measurements analysis of P1NP using Mixed model to test the treatment effect and the time effect. • Repeated measurements analysis of CTX-1 using Mixed model to test the treatment effect and the time effect. • hPTH (1-34) Pharmacokinetic parameters (AUC, Cmax, ) of ViaDerm-hPTH (1-34) and Forteo SC at baseline and Day 96/early termination. • Compare the ratio of hPTH (1-34) AUC of transdermal treatment and Forteo SC. • Compare the ratio of hPTH (1-34) Cmax of transdermal treatment and Forteo SC. Safety Endpoints: • Percentages of patients with serum total calcium level exceeding the upper limit of the normal range. • Percentages of patients with serum total calcium level more than 1 mg/dl above the upper limit of the normal range. ;Primary end point(s): The change in procollagen 1 N-terminal Polypeptide (P1NP-1) from baseline to Day 96. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed