Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
Primary Purpose
Osteoporosis, Osteopenia, Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Basic treatment group
Basic treatment+ anti-osteoporosis drug group
Basic treatment + non-drug treatment group
Sponsored by
About this trial
This is an interventional other trial for Osteoporosis focused on measuring Anti-osteoporosis therapy, men, Postmenopausal women
Eligibility Criteria
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
Sites / Locations
- PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Other
Arm Label
Basic treatment group
Basic treatment+ anti-osteoporosis drug group
Basic treatment + non-drug treatment group
Arm Description
elemental calcium 600mg/ day + vitamin D 1000IU/day
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
diet, exercise, rehabilitation therapy
Outcomes
Primary Outcome Measures
The efficacy on BTMs level
The change of BTMs level after different interventions
The efficacy on BDM level
The change of BDM level after different interventions
Secondary Outcome Measures
Fracture rate
Fracture rate during follow up
The type and rate of drug adverse reactions
The type and rate of drug adverse reactions during follow up
Full Information
NCT ID
NCT04719572
First Posted
January 15, 2021
Last Updated
January 21, 2021
Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Jishuitan Hospital, Beijing Aerospace General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04719572
Brief Title
Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
Official Title
Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Jishuitan Hospital, Beijing Aerospace General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia, Osteoporosis
Keywords
Anti-osteoporosis therapy, men, Postmenopausal women
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basic treatment group
Arm Type
Other
Arm Description
elemental calcium 600mg/ day + vitamin D 1000IU/day
Arm Title
Basic treatment+ anti-osteoporosis drug group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Basic treatment + non-drug treatment group
Arm Type
Other
Arm Description
diet, exercise, rehabilitation therapy
Intervention Type
Other
Intervention Name(s)
Basic treatment group
Intervention Description
A total of 60 subjects were recruited in the group.
Intervention Type
Other
Intervention Name(s)
Basic treatment+ anti-osteoporosis drug group
Intervention Description
A total of 60 subjects were recruited in the group.
Intervention Type
Other
Intervention Name(s)
Basic treatment + non-drug treatment group
Intervention Description
A total of 60 subjects were recruited in the group.
Primary Outcome Measure Information:
Title
The efficacy on BTMs level
Description
The change of BTMs level after different interventions
Time Frame
3 months、6months、9months、12months
Title
The efficacy on BDM level
Description
The change of BDM level after different interventions
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Fracture rate
Description
Fracture rate during follow up
Time Frame
12 months
Title
The type and rate of drug adverse reactions
Description
The type and rate of drug adverse reactions during follow up
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlin Li, M.D&Ph.D
Phone
+86-13810921655
Email
lichunlin301@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunlin Li, M.D&Ph.D
Organizational Affiliation
PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
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Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
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