Primary postmenopausal osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: Preotact
Product Name: Preotact
Pharmaceutical Form: Powder and solvent for suspension for injection
Trade Name: Protelos
Product Name: Protelos
Pharmaceutical Form: Granules for oral sus
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 activity 2. Is the subject female and at or above the age of 50 3. Has the subject been postmenopausal for more than 5 years -in the judgement of the investigator 4. Does the subject have primary osteoporosis and a T-score equal to or less than -3 SD; T-scores should be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcemia? 6. Has the subject been taking supplemental calcium (1000mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for eligibility evaluation? 7.Is the subject able to self-inject PTH(1-84), or get the injections by a helper? 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: Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to a) 5.0 mg prednisolon or equivalent daily for 3 months during the last year or b) 2.5mg prednisolon or equivalent for 6 months during the last year(local and inhalation steroids are permitted). 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? – according to the investigator’s opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism, Paget’s disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3 (serum 25(OH)D) level 65pg/ml and also a total serum calcium value >2.49 mmol/l? 18. have hypercalcaemia (total serum calcium value >2.55mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN2 20. have impaired kidney function with creatinine clearance 9 on the Child-Pugh scale)? 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? – according to the investigator’s opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis;Secondary Objective: ;Primary end point(s): • Change in N-terminal Propeptides of Human Pro-collagen type I (P1NP) from baseline to end of treatment (24 weeks). • Change in bone specific alkaline phosphatase (BSAP) from baseline to end of treatment (24 weeks) | — |
Countries
Austria, Spain
Outcome results
None listed