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Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

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ClinicalTrials.gov Identifier: NCT04719572
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 25, 2021
Sponsor:
Collaborators:
Beijing Jishuitan Hospital
Beijing Aerospace General Hospital
Information provided by (Responsible Party):
Chunlin Li, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia, Osteoporosis Other: Basic treatment group Other: Basic treatment+ anti-osteoporosis drug group Other: Basic treatment + non-drug treatment group Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arms and Interventions
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Arm Intervention/treatment
Basic treatment group
elemental calcium 600mg/ day + vitamin D 1000IU/day
 Other: Basic treatment+ anti-osteoporosis drug group
A total of 60 subjects were recruited in the group.

Other: Basic treatment + non-drug treatment group
A total of 60 subjects were recruited in the group.
Active Comparator: Basic treatment+ anti-osteoporosis drug 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
A total of 60 subjects were recruited in the group.

Other: Basic treatment + non-drug treatment group
A total of 60 subjects were recruited in the group.
Basic treatment + non-drug treatment group
diet, exercise, rehabilitation therapy
 Other: Basic treatment group
A total of 60 subjects were recruited in the group.

Other: Basic treatment+ anti-osteoporosis drug group
A total of 60 subjects were recruited in the group.


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy on BTMs level [ Time Frame: 3 months、6months、9months、12months ]
    The change of BTMs level after different interventions

  2. The efficacy on BDM level [ Time Frame: 12 months ]
    The change of BDM level after different interventions


Secondary Outcome Measures :
  1. Fracture rate [ Time Frame: 12 months ]
    Fracture rate during follow up

  2. The type and rate of drug adverse reactions [ Time Frame: 12 months ]
    The type and rate of drug adverse reactions during follow up


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719572


Contacts
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Contact: Chunlin Li, M.D&Ph.D +86-13810921655 lichunlin301@163.com

Locations
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China, Beijing
PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Beijing Jishuitan Hospital
Beijing Aerospace General Hospital
Investigators
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Principal Investigator: Chunlin Li, M.D&Ph.D PLA General Hospital
More Information
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Responsible Party: Chunlin Li, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04719572    
Other Study ID Numbers: antiosteoporosis301
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chunlin Li, Chinese PLA General Hospital:
Anti-osteoporosis therapy
men
Postmenopausal women
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases