A multi-center, randomized, open-label, controlled, one-year trial to measure the effect of zoledronic acid and alendronate on bone metabolism in post menopausal women with osteopenia and osteoporosis - ROSE

• Conditions: osteopenia/osteoporosis in postmenopausal women; MedDRA version: 8.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2006-001703-11-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < 10 pg/ml
d.hysterectomized women over or equal to 65 years of age
2.documented T-score of -2.0 or lower; total hip or spine (mean of L1-L4, excluding fractured vertebrae); measured by DXA; measured within a period of 3 month prior to screening
3.signed informed consent prior to initiation of any study procedure

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.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 < 2.00 mmol/L (8.0 mg/dL)
6.serum alkaline phosphatase higher than 2.5 times the upper limit of normal
7.history of hypersensitivity to the study drugs or to drugs with similar chemical structures
8.AST or ALT greater than twice the upper limit of normal
9.history of uveitis, iritis or chronic conjunctivitis
10.history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM Hb1AC > 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

Study & Design

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