Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedJanuary 25, 2021
January 1, 2021
1.5 years
January 15, 2021
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Fracture rate
12 months
The type and rate of drug adverse reactions
12 months
Study Arms (3)
Basic treatment group
OTHERelemental calcium 600mg/ day + vitamin D 1000IU/day
Basic treatment+ anti-osteoporosis drug group
ACTIVE COMPARATORalendronate(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
Basic treatment + non-drug treatment group
OTHERdiet, exercise, rehabilitation therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Beijing Jishuitan Hospitalcollaborator
- Beijing Aerospace General Hospitalcollaborator
Study Sites (1)
PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunlin Li, M.D&Ph.D
PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 22, 2021
Study Start
March 1, 2021
Primary Completion
September 1, 2022
Study Completion
January 1, 2023
Last Updated
January 25, 2021
Record last verified: 2021-01