Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Group1: Basic treatment group (elemental calcium 600mg/ day + vitamin D 1000IU/day) Group2: Basic treatment+ anti-osteoporosis drug group (alendronate, zoledronate, tripopeptide, denosumab, activated vitamin D, menatetrenone soft capsules according to the patient's condition) Group3: Basic treatment + non-drug treatment group(diet, exercise, rehabilitation therapy). 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.

Official Title
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Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis

Conditions
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Osteoporosis, Osteopenia, Osteoporosis

Intervention / Treatment
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* Other: Basic treatment group
* Other: Basic treatment+ anti-osteoporosis drug group
* Other: Basic treatment + non-drug treatment group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any trial-related activities Postmenopausal women and male aged 50 years or old Osteoporosis by DXA or fragility fracture history Osteopenia with more than one osteoporotic risk factors Exclusion Criteria: Secondary osteoporosis Renal insufficiency (Ccr< 35ml/min) New fractures < 3 months, prior bilateral hip fractures or surgical replacement. Other medication contraindications Malignant tumors Mobility-impaired individuals

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Basic treatment group<br>elemental calcium 600mg/ day + vitamin D 1000IU/day | Other: Basic treatment+ anti-osteoporosis drug group<br>* A total of 60 subjects were recruited in the group.<br>Other: Basic treatment + non-drug treatment group<br>* A total of 60 subjects were recruited in the group.<br>|
| Active Comparator: Basic treatment+ anti-osteoporosis drug group<br>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<br>* A total of 60 subjects were recruited in the group.<br>Other: Basic treatment + non-drug treatment group<br>* A total of 60 subjects were recruited in the group.<br>|
| Other: Basic treatment + non-drug treatment group<br>diet, exercise, rehabilitation therapy | Other: Basic treatment group<br>* A total of 60 subjects were recruited in the group.<br>Other: Basic treatment+ anti-osteoporosis drug group<br>* A total of 60 subjects were recruited in the group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy on BTMs level | The change of BTMs level after different interventions | 3 months、6months、9months、12months | 
| The efficacy on BDM level | The change of BDM level after different interventions | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture rate | Fracture rate during follow up | 12 months | 
| The type and rate of drug adverse reactions | The type and rate of drug adverse reactions during follow up | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-osteoporosis therapy, men, Postmenopausal women