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NCT Number: NCT06134908

PRevention of OsTEoporotiC FracTure 2 Pilot Study

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.

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Key information

Conditions

Fragility Fracture Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Multifaceted intervention

Behavioral

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.

Primary outcomes

  1. Trial feasibility - Recruitment

    Time frame: 3 months

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

  2. Trial feasibility - Acceptability of the multicomponent program component

    Time frame: 30 days after study recruitment

    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.

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

    Time frame: 7 days after study recruitment

    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.

  4. Trial feasibility - Retention

    Time frame: 30 days after study recruitment

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

Secondary outcomes

  1. Anti-osteoporosis treatment rate

    Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

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

  2. Shared decision-making process

    Time frame: 7 days after study recruitment

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

  3. Bone mineral density test

    Time frame: 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

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

  4. Adherence of anti-osteoporosis medication

    Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

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

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

    Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

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

  6. Refracture

    Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

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

  7. Survival

    Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

    The patients will be followed up about their survival status.

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

    Time frame: baseline; 1 month follow-up; 6 month follow-up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Mo, MD

CONTACT

[email protected]

+86 (020) 85252900

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Dongguan Eighth People's Hospital
  • Longgang Orthopedics Hospital of Shenzhen
  • Sir Run Run Shaw Hospital
  • The First People's Hospital of Hefei
  • The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • The Third People's Hospital of Longgang District Shenzhen

Registry information

Official study 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

Acronym: PROTECT-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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