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A cross-over study to compare tolerability and efficacy of brand versus generic alenronate in postmenopausal women with osteoporosis.

A cross-over study to compare tolerability and efficacy of brand versus generic alenronate in postmenopausal women with osteoporosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26372
Enrollment
30
Registered
2009-06-18
Start date
2009-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Postmenopausal Osteoporosis, tolerability, efficacy, Bisfosfonates Osteoporose, tolerantie, werkzaamheid, bisfofonaten

Interventions

Lichamelijk onderzoek, interview, bloed en urine onderzoek, invullen vragenlijsten.

Sponsors

Investigator initiated trial ( IIT )
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Vergelijken van tolerantie en effectiviteit (dmv van vragenlijsten en botmarkers) van specialite alendronate ten opzichte van generiek alendronate.

Contacts

Public ContactJ.P.W. Bergh, van den

Tegelseweg 210

jvdbergh@viecuri.nl+31 (0)77-3205555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)