Intervention Study of Drugs in Patients Osteopenia and Osteoporosis

January 21, 2021 updated by: Chunlin Li, Chinese PLA General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 + non-drug treatment group
A total of 60 subjects were recruited in the group.
Other: Basic treatment group
A total of 60 subjects were recruited in the group.
Other: Basic treatment + non-drug treatment group
diet, exercise, rehabilitation therapy
Other: Basic treatment+ anti-osteoporosis drug group
A total of 60 subjects were recruited in the group.
Other: Basic treatment group
A total of 60 subjects were recruited in the group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Beijing Jishuitan Hospital
Beijing Aerospace General Hospital

Investigators

  • Principal Investigator: Chunlin Li, M.D&Ph.D, PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • antiosteoporosis301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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