OsteoporosisNCT04719572
Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
A study testing Basic treatment group, Basic treatment+ anti-osteoporosis drug group and Basic treatment + non-drug treatment group in people with Osteoporosis and Osteopenia, Osteoporosis, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Osteopenia, Osteoporosis
- What is being tested?
- Basic treatment group, Basic treatment+ anti-osteoporosis drug group and Basic treatment + non-drug treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Mar 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
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.
Read the 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.
- Conditions
- Osteoporosis, Osteopenia, Osteoporosis
- Being tested
- Basic treatment group, Basic treatment+ anti-osteoporosis drug group, Basic treatment + non-drug treatment group
- Keywords
- Anti-osteoporosis therapy, men, Postmenopausal women
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic treatment groupOther
A total of 60 subjects were recruited in the group.
Basic treatment+ anti-osteoporosis drug groupOther
A total of 60 subjects were recruited in the group.
Basic treatment + non-drug treatment groupOther
A total of 60 subjects were recruited in the group.
| Study group | Role | What they receive |
|---|---|---|
| Basic treatment group | Other | elemental calcium 600mg/ day + vitamin D 1000IU/day Receives: Other: Basic treatment+ anti-osteoporosis drug group; Other: Basic treatment + non-drug treatment group |
| Basic treatment+ anti-osteoporosis drug group | Active comparator | 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 Receives: Other: Basic treatment group; Other: Basic treatment + non-drug treatment group |
| Basic treatment + non-drug treatment group | Other | diet, exercise, rehabilitation therapy Receives: Other: Basic treatment group; Other: Basic treatment+ anti-osteoporosis drug group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy on BTMs level
The change of BTMs level after different interventions
Measured: 3 months、6months、9months、12months
The efficacy on BDM level
The change of BDM level after different interventions
Measured: 12 months
Secondary outcomes (2)
Fracture rate
Fracture rate during follow up
Measured: 12 months
The type and rate of drug adverse reactions
The type and rate of drug adverse reactions during follow up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Beijing Aerospace General Hospital
- Responsible party
- Principal investigator, Chunlin Li, Chinese PLA General Hospital
- Investigators
- Chunlin Li, M.D&Ph.D, Principal investigator, PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719572
- Sponsor's protocol ID
- antiosteoporosis301
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
- ClinicalTrials.gov ID
- NCT04719572
- Acronym / sponsor ID
- antiosteoporosis301
- Conditions
- Osteoporosis, Osteopenia, Osteoporosis
- Keywords
- Anti-osteoporosis therapy, men, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, Beijing Aerospace General Hospital
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic treatment group | Other | Other: Basic treatment+ anti-osteoporosis drug group, Other: Basic treatment + non-drug treatment groupelemental calcium 600mg/ day + vitamin D 1000IU/day |
| Basic treatment+ anti-osteoporosis drug group | Active comparator | Other: Basic treatment group, Other: Basic treatment + non-drug treatment groupalendronate(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 | Other | Other: Basic treatment group, Other: Basic treatment+ anti-osteoporosis drug groupdiet, exercise, rehabilitation therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Secondary osteoporosis
- Renal insufficiency (Ccr< 35ml/min)
- New fractures < 3 months, prior bilateral hip fractures or surgical replacement.
- Other medication contraindications
- Malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic treatment groupA total of 60 subjects were recruited in the group. | Other | Basic treatment + non-drug treatment group, Basic treatment+ anti-osteoporosis drug group |
| Basic treatment+ anti-osteoporosis drug groupA total of 60 subjects were recruited in the group. | Other | Basic treatment + non-drug treatment group, Basic treatment group |
| Basic treatment + non-drug treatment groupA total of 60 subjects were recruited in the group. | Other | Basic treatment group, Basic treatment+ anti-osteoporosis drug group |
Primary outcome
The efficacy on BTMs level
Time frame: 3 months、6months、9months、12months
The change of BTMs level after different interventions
The efficacy on BDM level
Time frame: 12 months
The change of BDM level after different interventions
2 secondary outcomes
Fracture rate
Time frame: 12 months
The type and rate of drug adverse reactions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunlin Li, M.D&Ph.D principal investigator
PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic treatment group, Basic treatment+ anti-osteoporosis drug group and Basic treatment + non-drug treatment group in people with Osteoporosis and Osteopenia, Osteoporosis, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlin Li, M.D&Ph.D (+86-13810921655, lichunlin301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy on BTMs level (time frame: 3 months、6months、9months、12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.