ow Dose Intravenous Zoledronate for the Treatment of Post-menopausal Osteoporosis: a prospective open-labeled study
- Conditions
- Postmenopausal osteoporosispostmenopausal osteoporosis, zoledronate, bone mineral density, fracture, prevention
- Registration Number
- TCTR20210930001
- Lead Sponsor
- Phramongkutklao hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 36
postmenopausal osteoporotic women from the Internal Medicine and Rheumatology Outpatient Clinic, Phramongkutklao Hospital between July 2018 and December 2019. In all the women, menopause had occurred at least five years previously, either naturally or as the result of bilateral oophorectomy. Osteoporosis is defined according to the WHO criteria, as a BMD either at the lumbar spine or hip of less than 2.5 standard deviations or more below the average value for young healthy women (a T-score of <-2.5 SD).
patients who previously received anti-resorptive treatment including bisphosphonate, estrogen replacement therapy, calcitonin and raloxifene, moderate to severe renal impairment (GFR < 35 mL/min estimated by CKD-EPI equation,8 allergic to bisphosphonates, planning for invasive dental surgery within 12 months after Zoledronate infusion, history of atrial fibrillation, history of hyperparathyroidism, vitamin D insufficiency and evidence of secondary osteoporosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umbar bone mineral density 12 months Lumbar bone mineral density (g/cm2) by DXA scan
- Secondary Outcome Measures
Name Time Method Total hip bone mineral density 12 months Total hip bone mineral density (g/cm2) by DXA scan