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Fragility FracturePROTECT-2NCT06134908

PRevention of OsTEoporotiC FracTure 2 Pilot Study

A study testing Multifaceted Intervention in people with Fragility Fracture, run by Third Affiliated Hospital, Sun Yat-Sen University at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Fragility Fracture
What is being tested?
Multifaceted Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
7 sitesChina
Study dates
13 Jan 2024to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Local residents (live in the city where the hospital is located for half a year or more);
  • Hospitalized patients with fractures aged 50 years and above;
  • First fracture, without history of fracture;
  • Never diagnosed as "osteoporosis" before admission;
  • No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;
  • Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;
Show all 9Show fewer
  • New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks;
  • Not living in a nursing or rehabilitation institution before fracture;
  • Possess reading ability, and can read and understand informed consent forms or medical materials independently.

Who cannot join

  • Patients with pathological fractures caused by tumor or infection;
  • Patients with cognitive dysfunction or mental disorder;
  • AIDS patients;
  • Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
  • Hearing or visual impairment, and unable to communicate or read materials;
  • Patients who have participate in other studies;
  • Other conditions that the investigator considered inappropriate to enroll.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Mo, MD contact

+86 (020) 85252900

mojian3@mail.sysu.edu.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • The Second Affiliated Hospital of Hunan University of Chinese Medicine

    Changsha

    Jingqi Zeng, MD

    Recruiting

  • Dongguan Eighth People's Hospital

    Dongguan

    Wenbo Cui, MD

    Recruiting

  • Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou

    Jian Mo, MD, +86 (020) 85252900, mojian3@mail.sysu.edu.cn

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou

    Shunwu Fan, MD

    Recruiting

  • The First People's Hospital of Hefei

    Hefei

    Zhou Dong, MD

    Recruiting

  • Longgang Orthopedics Hospital of Shenzhen

    Shenzhen

    Jie Li, MD

    Recruiting

  • The Third People's Hospital of Longgang District Shenzhen

    Shenzhen

    Shaomin Huang, MD

    Recruiting

Other trials in China

About this study

Official title: The Application of "Precise Education + Shared Decision-Making" Program for the Secondary Prevention of Fragility Fractures Based on Behavioral Theories: A Pilot Cluster Randomized Controlled Trial

With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China.

As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China.

The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.

Being tested
Multifaceted Intervention
Keywords
Osteoporosis, Fragility Fracture, Shared Decision-Making, Education
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multifaceted InterventionBehavioural

    The multicomponent intervention elements include education for clinicians and patients as well as a shared decision-making program among clinicians and patients. A shared decision-making booklet and a mobile application will be used to promote osteoporosis management and fracture practice.

Study groups in NCT06134908
Study groupRoleWhat they receive
Multifaceted InterventionExperimentalGroup in the intervention arm will receive a multicomponent intervention at the clinician- and patient-level, with a shared decision-making booklet as well as a mobile application to promote osteoporosis management and fracture practice.
Receives: Behavioral: Multifaceted Intervention
Usual-care ControlNo interventionGroup in the control arm will receive a leaflet and routine medical care per their existing health care providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trial feasibility - Recruitment

    Number or N (%) participants recruited within 3 months of trial initiation at each centre.

    Measured: 3 months

  2. Trial feasibility - Acceptability of the multicomponent program component

    Participants will be asked to evaluate the program with a questionnaire with questions about frequency, length, content, delivery, and duration of the booklet and the mobile application using a 5-point Likert scale.

    Measured: 30 days after study recruitment

  3. Trial feasibility - Acceptability of the shared decision-making process

    Both clinicians and patients will be asked to evaluate the shared decision-making process once they completed it. A survey will be administered to evaluate the content and comprehension of the program using a 5-point Likert scale.

    Measured: 7 days after study recruitment

  4. Trial feasibility - Retention

    The retention rates will be assessed as the 30-day follow-up rate.

    Measured: 30 days after study recruitment

Secondary outcomes (8)

  1. Anti-osteoporosis treatment rate

    The patients will be followed up and asked whether they accept any anti-osteoporosis medication.

    Measured: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  2. Shared decision-making process

    Standardized questionnaires will be used to evaluated the shared decision-making process.

    Measured: 7 days after study recruitment

  3. Bone mineral density test

    The patients will be followed up and asked whether they accept bone mineral density test.

    Measured: 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  4. Adherence of anti-osteoporosis medication

    Adherence of anti-osteoporosis medication will be assessed with medication possession ratio and self-reported question.

    Measured: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  5. Diagnosis, education, and follow-up practice of osteoporosis

    The patients will be followed up with questionnaires about diagnosis, education, and follow-up of osteoporosis.

    Measured: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  6. Refracture

    The patients will be followed up and asked whether they have refracture.

    Measured: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  7. Survival

    The patients will be followed up about their survival status.

    Measured: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

  8. Patients' knowledge and attitude about osteoporosis and fragility fracture

    Patients' knowledge and attitude about osteoporosis and fragility fracture will be evaluated with standardized questionnaires.

    Measured: baseline; 1 month follow-up; 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start13 Jan 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134908
Sponsor's protocol ID
PROTECT-2 Pilot
Acronym
PROTECT-2
Status last verified
May 2024
First submitted
11 Nov 2023
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multifaceted Intervention in people with Fragility Fracture, run by Third Affiliated Hospital, Sun Yat-Sen University at 7 sites 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jian Mo, MD (+86 (020) 85252900, mojian3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trial feasibility - Recruitment (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134908.

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 28 May 2024.

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