|- candidate number||5972|
|- NTR Number||NTR1867|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jun-2009|
|- Secondary IDs||09-016 Viecuri MC|
|- Public Title||A cross-over study to compare tolerability and efficacy of brand versus generic alenronate in postmenopausal women with osteoporosis.|
|- Scientific Title||A cross-over study to compare tolerability and efficacy of brand versus generic alenronate in postmenopausal women with osteoporosis.|
|- ACRONYM||Generic study|
|- hypothesis||Evaluation of difference in tolerability and efficacy as measured by bonemarkers between generic versus brand alendronate in postmenopausal women with osteoporosis.|
|- Healt Condition(s) or Problem(s) studied||Osteoporosis, Postmenopausal women|
|- 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;
3. No treatment for osteoporosis in the 12 month before inclusion;
4. Ability to understand study procedures and to comply with them for the entire lenght of the study.
|- 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;
3. Patients with disorders of esophageal motility or in whom oral bisfosfonates are contraindicated;
4. A history of upper GI tract disorder other than esophageal motility disorder is not a reason for exclusion.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2009|
|- planned closingdate||1-mei-2010|
|- Target number of participants||30|
|- Interventions||Lichamelijk onderzoek, interview, bloed en urine onderzoek, invullen vragenlijsten.|
|- Primary outcome||Vergelijken van tolerantie en effectiviteit (dmv van vragenlijsten en botmarkers) van specialite alendronate ten opzichte van generiek alendronate.|
|- Secondary outcome||Geen.|
|- Timepoints||Na screeningsperiode van max 89 dagen (max 2 visits) behandelperiode: 24 weken met op week 12 cross-over; in totaal 2 visits. |
|- Trial web site||NA|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr J.P.W. Bergh, van den|
|- CONTACT for SCIENTIFIC QUERIES||Dr J.P.W. Bergh, van den|
|- Sponsor/Initiator ||Investigator initiated trial ( IIT )|
(Source(s) of Monetary or Material Support)
|Investigator initiated trial ( IIT )|
|- Brief summary||Study Title:|
Comparison of tolerability and efficacy of brand versus generic alendronate.
Evaluation of difference in tolerability and efficacy as measured by bone markers between generic versus brand alendronate in postmenopausal women with osteoporosis.
Design and Outcomes:
A randomized single centre cross-over study to test the tolerability and efficacy of brand compared to generic alendronate in postmenopausal women with established osteoporosis. Tolerability is evaluated by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Medication use and adherence is evaluated by the Self-efficacy for Appropriate Medication Use (SEAMS) Questionnaire and the Brief Medication Questionnaire (BMQ). Efficacy is evaluated by the assessment of bone-markers.
Interventions and Duration:
After randomization, patients start with generic alendronate or brand oral alendronate once weekly in a single blinded, open label setting. After the first period of 12 weeks, there is a cross-over to branded and generic oral alendronate once weekly respectively. Evaluation of tolerability, adherence and efficacy is planned at week 6, 12, 18 and 24. After the study period of 24 weeks patients will continue treatment with the alendronate formulation they prefer, according to current practice.
Sample Size and Population:
30 postmenopausal women with osteoporosis defined as a DEXA T-score <-2,5 SD and/or ¡Ý 1 vertebral fracture.
|- Main changes (audit trail)|
|- RECORD||18-jun-2009 - 16-apr-2011|