An interventional study of Basic treatment group and Basic treatment+ anti-osteoporosis drug group in Osteoporosis and Osteopenia, Osteoporosis, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Other
This is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies.
This is a 12 months,randomized, multicenter, open-label, pragmatic-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies, including
Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 180 postmenopausal women and elderly male with osteoporosis or osteopenia will be included in this study.
All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D, bone turnover markers(BTMs) (inculding serum procollagen type I N-propeptide, serum C-terminal telopeptide of type I collagen,osteocalcin and alkaline phosphatase), thoracic and lumbar spine X-ray, bone mineral density(BMD) by dual energy X-ray.
Then they will be randomized into three groups at a 1:1 ratio. Every group will be given calcium carbonate and vitamin D. In the group 2, the medication will be decided by the doctor according to the patients' condition. Particularly, denosumab has not been approved for male adaptation, we will sign an additional informed consent.
All subjects will be followed by visiting clinic every three months and complete the examinations to assess the safety and efficacy. Safety indexes: liver and kidney function, urine routine test and 24-h urine calcium. Efficacy indexes: BMD change, BTMs changes and fracture reduction. All subjects will be followed 12 months and data will be collected and analyzed.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 180 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
elemental calcium 600mg/ day + vitamin D 1000IU/day
Other: Basic treatment+ anti-osteoporosis drug group · Other: Basic treatment + non-drug treatment group
alendronate(70mg/week), zoledronate(5mg 1/ year), tripopeptide(20ug 1/day), denosumab(120mg/month), activated vitamin D(0.25ug 1/day), menatetrenone(15mg tid) according to the patient's condition
Other: Basic treatment group · Other: Basic treatment + non-drug treatment group
diet, exercise, rehabilitation therapy
Other: Basic treatment group · Other: Basic treatment+ anti-osteoporosis drug group
A total of 60 subjects were recruited in the group.
A total of 60 subjects were recruited in the group.
A total of 60 subjects were recruited in the group.
The efficacy on BTMs level
The change of BTMs level after different interventions
Time frame: 3 months、6months、9months、12months
The efficacy on BDM level
The change of BDM level after different interventions
Time frame: 12 months
Fracture rate
Fracture rate during follow up
Time frame: 12 months
The type and rate of drug adverse reactions
The type and rate of drug adverse reactions during follow up
Time frame: 12 months
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital