A cross-over study to compare tolerability and efficacy of brand versus generic alenronate in postmenopausal women with osteoporosis.
Completed
- Conditions
- Postmenopausal Osteoporosis, tolerability, efficacy, BisfosfonatesOsteoporose, tolerantie, werkzaamheid, bisfofonaten
- Registration Number
- NL-OMON26372
- Lead Sponsor
- Investigator initiated trial ( IIT )
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Postmenopausal women 50 yrs or >;
2. Diagnosed with osteoporosis as defined by: DEXA: T-score of-2.5 at lumbar spine or femoral neck os total hip, and or a vertebral fracture;
Exclusion Criteria
1. Patients with prior teratment of osteoporosis (bisfofonates, testosterone, hormone replacement therapy( HRT) , selective estrogen receptor modulators ( SERMs) or calcitonin);
2. Patients who are previously intolerant of bisfosfonates;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vergelijken van tolerantie en effectiviteit (dmv van vragenlijsten en botmarkers) van specialite alendronate ten opzichte van generiek alendronate.
- Secondary Outcome Measures
Name Time Method