Primary postmenopausal osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: Preotact
Product Code: PTH (1-84)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid Hormone
CAS Number: 68893-82-3
Current Sponsor code: P
Sponsors
Nycomed Danmark Aps
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject above 50 years old? 3. Is the subject postmenopausal (more than 5 years) – in the judgement of the investigator? 4. Does the subject have primary osteoporosis with a lumbar spine T score equal to or less than -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)? 5. Does the subject have a life expectancy of >3 years? 6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)? Bone biopsy sub trial: 7. Has the subject given consent to having a bone biopsy performed? 8. Has the subject completed trial period II in FP-001-IM? 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. Is the subject currently in treatment with Selective Estrogen Receptor Modulators (SERMs) (e.g. raloxifen)? If the SERM treatment is terminated the subject can still be evaluated for eligibility. 2. Has the subject ever been treated with any bisphosphonate other than alendronate or risedronate? 3. Has the subject been treated with alendronate or risedronate for more than 3 years in total? 4. Has the subject during lifetime been treated with both alendronate and risedronate, including sequential treatment? 5. Has the subject during lifetime been treated with strontium > 3 months in total? 6. Has the subject during lifetime been treated with fluoride > 3 months in total? 7. Has the subject during lifetime been treated with teriparatide or PTH (1-84)? 8. Has the subject during lifetime been treated with calcitonin during the last 3 months? 9. Is the subject currently receiving antiepileptic medication? 10. Does the subject take any other medication, that according to investigator’s opinion, is known to affect bone metabolism? 11. Has the subject received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: • 5.0mg prednisolon or equivalent daily for 3 months during the last year or • 2.5mg prednisolon or equivalent daily for 6 months during the last year 12. Has the subject ever received radiation therapy to the skeleton? 13. Has the subject been treated for cancer (other than basocellular skin cancer) within the last 5 years? 14. Has the subject ever had malignant disease affecting the skeleton? 15. Has the subject ever had breast cancer? 16. Does the subject have any known clinically significant diseases affecting calcium metabolism? 17. Does the subject have any known history of metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget’s disease, osteogenesis imperfecta, or osteomalacia)? 18. Does the subject have a medical history of abnormalities in oesophagus prohibiting emptying of oesophagus (e.g. achalasia or stricture) and inability to ingest risedronate (should be able to take risedronate upright) judged by the investigator to be significant? 19. Does the subject have any known history of hypersensitivity to parathyroid hormone or risedronate or any of the excipients in the products? 20. Does the subject have any clinically significant conduction abnormalities e.g. second degree atrial ventricular block as assessed by the investigator based on ECG reading? 21. Does the subject have a plasma 25-hydroxyvitamin D level 65pg/ml and a total serum calcium value >2.49 mmol/l? 23. Does the subject have hypercalcaemia (total serum calcium value >2.55mmol/l) after at least 14 days of calcium supplementation? 24. Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator? 25. Does the subject have impaired kidney function with creatinine clearance 360mg after at least 14 days of calcium supplementation? 27. Has the subject ever shown intolerance to any bisphosphonate? 28. Is the subject scheduled for vertebroplasty? 29. Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate. ;Secondary Objective: Not applicable;Primary end point(s): Change in lumbar spine BMD (measured by Dual X-ray Absorptiometry (DXA)) from start of trial period III to end of trial period III. | — |
Countries
Germany, Greece, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed