postmenopausal women postmenopausal women osteoporosis BMD Bone turnover markers risedronate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.postmenopausal osteoporotic women (not menstruated for at least 1 year) 2.diagnosed with osteoporosis by Dual-energy X-ray Absorptiometry (DXA) with a T-score < 2.5 at the total lumbar spine or L1-L4, femoral neck, or total hip for at least one site
Exclusion criteria
Exclusion criteria: 1. had been treated for osteoporosis in 12 months 2. had medications known to interfere with BTMs such as corticosteroids and antiepileptic drugs 3. had recent fracture in the 12 months 4.known case thyroid disorders 5.parathyroid disorders 6.renal insufficiency 7.rheumatoid disease 8.Cushing disease 9.multiple myeloma and 10.cancers involving bone health 11.unable to sit or stand in an upright position for at least 30 mins after taking medications 12.experiencing severe upper gastrointestinal tract symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of serum CTX levels between baseline and 12 weeks after generic risedronate treatment 0 and 12 weeks Blood test | — |
Secondary
| Measure | Time frame |
|---|---|
| comparison of serum CTX levels between baseline and 52 weeks after treatment 0 and 52 weeks Blood test,Comparison of serum P1NP levels between baseline and 24 weeks after treatment 0 and 24 weeks Blood test,Comparison of lumbar spine, femoral neck, and total hip BMD at baseline and 52 weeks of treatment 0 and 52 weeks BMD,percentage of patients experiencing adverse effects from generic risedronate 0, 12 , 24, 52 weeks questionnaire | — |
Countries
Thailand
Contacts
Chulalongkorn University