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Holonomic Empower Management model of Bone and Metabolic Health: a multicenter, real-world cohort study with long-term follow-up

Holonomic Empower Management model of Bone and Metabolic Health: a multicenter, real-world cohort study with long-term follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300068676
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Osteoporosis group:Basic treatment and anti-osteoporosis sequential treatment
Osteopenia group:Regular screening and basic treatment
Normal bone metabolism group:Regular screening

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects at risk of bone metabolism whose IOF one minute test result is "Yes"; 2. Definitely diagnose patients with osteopenia or osteoporosis; 3. Subjects who can keep regular visits (1-2 times per year), age>18 years (inclusive); 4. Sign the informed consent voluntarily; 5. Patients who can cooperate with the Holonomic Empower Management model of Bone and Metabolic Health.

Exclusion criteria

Exclusion criteria: 1. Patients with major organ failure or other serious diseases with unstable situation, including but not limited to patients with myocardial infarction, severe mental disorder, severe infection or disseminated intravascular coagulation within 12 months before enrollment; 2. Patients with active or inactive malignant tumors with life expectancy less than 1 year; 3. Patients who have communication barriers and cannot fully understand or cooperate; 4. Patients who cannot accept remote management based on applet or APP.

Design outcomes

Primary

MeasureTime frame
bone mineral density;Cumulative fracture events;

Secondary

MeasureTime frame
Annual BMD performance;Implementation of drug therapy within the anti osteoporosis treatment plan;Risk assessment and sequential execution degree in stage planning;Annual changes in BMD from baseline in patient treated with Oral diphosphate;Annual changes in Bone turnover index from baseline in patient treated with Oral diphosphate;Cumulative fracture events in patient treated with Oral diphosphate;Annual changes in BMD from baseline in patient treated with Intravenous diphosphate;Annual changes in Bone turnover index from baseline in patient treated with Intravenous diphosphate;Cumulative fracture events in patient treated with Intravenous diphosphate;Annual changes in BMD from baseline in patient treated with RANKL inhibitor;Annual changes in Bone turnover index from baseline in patient treated with RANKL inhibitor;Cumulative fracture events in patient treated with RANKL inhibitor;Annual changes in BMD from baseline in patient treated with Other anti osteoporosis drugs;Annual changes in Bone turnover index from baseline in patient treated with Other anti osteoporosis drugs;Cumulative fracture events in patient treated with Other anti osteoporosis drugs;Annual changes in BMD from baseline in Osteopenia patient treated with basic drugs;Annual changes in Bone turnover index from baseline in Osteopenia patient treated with basic drugs;Cumulative fracture events in Osteopenia patient treated with basic drugs;Cumulative incidence of major osteoporotic fractures (wrist, vertebral body, hip) among different subgroups;Cumulative fall incidence among different subgroups;Cumulative fracture/fall related hospitalization rates among different subgroups;Cumulative mortality among different subgroups;Direct costs of disease treatment for osteoporosis patients;Direct costs of bone metabolism related adverse events in patients with osteoporosis;Long term health economic benefits of managing osteoporosis patients calculated by health economics model;

Countries

China

Contacts

Public ContactLi Ang

Peking University First Hospital

liang850513@hotmail.com13681338795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026