Effects of generic risedronate on bone turnover markers and bone mineral density in Thai postmenopausal osteoporosis.
- Conditions
- postmenopausal womenosteoporosisBMDBone turnover markersrisedronate
- Registration Number
- TCTR20240427002
- Lead Sponsor
- Ratchadapisek Research Funds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of serum CTX levels between baseline and 12 weeks after generic risedronate treatment 0 and 12 weeks Blood test
- Secondary Outcome Measures
Name Time Method 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