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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002342-19-CZ

Enrollment

100

Registered

2005-06-23

Start date

2005-07-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal osteoporosis

Interventions

Trade Name: Alendros 70 Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: - percent change from baseline in lumbar spine bone mineral density at 12 month in women with postmenopausal osteoporosis - percent changes in proximal femur - percent changes from baseline to visit at 12 month in bone turnover markers	—

Measure

Time frame

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: - percent change from baseline in lumbar spine bone mineral density at 12 month in women with postmenopausal osteoporosis - percent changes in proximal femur - percent changes from baseline to visit at 12 month in bone turnover markers

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026