A multicentre, open label study to evaluate the safety and efficacy of Alendros 70 therapy administered 70mg once a week in women with postmenopausal osteoporosis
- Conditions
- postmenopausal osteoporosis
- Registration Number
- EUCTR2005-002342-19-CZ
- Lead Sponsor
- Zentiva, a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
•Female,
•ambulatory,
•age to 80 years
•Postmenopausal osteoporosis
•Meets the BMD criteria of the lumbar spine or proximal femur for osteoporosis
Are the trial subjects under 18?
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.have evidence of a clinically significant psychiatric or organic disease which could prevent the patient from completing the study
2.abuse of alcohol or use illicit drugs
3.any allergic or abnormal reaction to bisphosphonates
4. hypokalcemia
5. serious disease of the gastrointestinal tract
6. inability be seated for 30 minutes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to determine the safety profile of alendronat 70mg administered once a week in this patient population based on adverse event incidence and changes in laboratory profiles;Primary end point(s): to determine the safety profile of alendronat 70mg administered once a week;Secondary Objective: The secondary objectives is to determine the efficacy of alendronate 70 mg administered once a week as assessed by:<br>-percent change from baseline in lumbar spine bone mineral density at 12 month in women with postmenopausal osteoporosis<br>-percent changes in proximal femur<br>-percent changes from baseline to visit at 12 month in bone turnover markers<br>
- Secondary Outcome Measures
Name Time Method