osteopenia/osteoporosis in postmenopausal women MedDRA version: 8.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: Aclasta 5 mg Infusionslösung
Product Name: Aclasta 5 mg Infusionslösung
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Zoledronic acid (free of water)
CAS Number: 118072-9
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. women equal to or older than 55 and up to 90 years (inclusive) at randomization who will be considered post-menopausal according to the following definition: a. = 12 months of natural (spontaneous) amenorrhea or b. = 12 month post surgical bilateral oophorectomy or c. hysterectomized women under 65 years of age with a serum FSH > 20 IU/l and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. any woman of child-bearing potential 2. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) 3. history of fractures within six month prior to randomization 4. calculated creatinine clearance below 35 ml/min or urine dipstick 2+ or more for protein (without evidence of contamination or bacteriuria) 5. serum calcium > 2.75 mmol/l (11.0 mg/dL) or 10%. 11. history of abnormalities of the esophagus which may delay esophageal emptying. 12. not being able to stand or sit upright for 30 minutes 13. history of invasive malignancy of any organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases; excluding basal cell or squamous cell carcinoma of the skin. 14. treatment with an investigational drug within the past 30 days or 5 half-lives prior to randomization whichever is longer 15. history of organ transplantation 16. history of hypoparathyroidism, hyperparathyoidism, osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis 17. any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 12 months 18. any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial. 19. previous use of oral and i.v. bisphosphonates, PTH, strontium ranelate, sodium fluoride. 20. raloxifene, calcitonin,, tibolone or hormone replacement therapy within 6 months prior to randomization. 21. use of systemic high dose corticosteroids within 6 months prior to screening: a. at an average dose of =?7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening or b. at an average dose of 2.5 mg per day of oral prednisone or equivalent for a period of 6 months or more prior to screening 22. any treatment that affects bone metabolism (e.g. antiepileptics) 23. bilateral hip and spine surgery, that may interfere with the DXA measurements (e.g. hip replacement) 24. any kind of tooth extraction during the last 3 months or surgery of the jaw during the last 6 month before inclusion in the study 25. any kind of jaw bone disease or infection, that may necessitate oral surgery during the course of the study 26. history of drug or alcohol abuse within the last 2 years 27. history of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol. 28. any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing it 29. unwillingness or inability to give informed consent 30. persons directly involved in the execution of this protocol 31. any disease related litigation 32. recent history of kidney st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove superiority of zoledronic acid compared to alendronate by testing the hypothesis that the change of the level of NTx in serum within the first 12 months after start of therapy in postmenopausal women is higher.;Secondary Objective: • To compare the level of NTx and P1NP • To compare the level of NTx within subgroups defined by baseline characteristics • To compare the effect within subgroups defined by T-score level at entry (-2 to -2.5 (exclusive), -2.5 to -3.0 (exclusive), -3.0 to -3.5 (exclusive), -3.5 to -4.0 (exclusive), -4.0 and lower)) • To compare the level of compliance and persistence • Descriptive analysis of changes in safety lab, AE and vital signs • To explore patient preferences for annual i.v. therapy compared to weekly oral therapy • To explore the change in quality of life between zoledronic acid and alendronate as measured by VAS and Quallefo-41 • To explore the number of clinical fractures • To explore the change in body height • To explore the number of days on osteoporosis related sick leave • Descriptive evaluation of onset as well as offset of both treatments at the beginning and at the end of observation period by values of NTx.;Primary end point(s): The level of bone activity, as measured by NTx, over the course of 12 months will be assessed using the standardized area under the curve (AUC), which is the primary efficacy variable in this trial. | — |
Countries
Germany
Outcome results
None listed