Skip to content

A prospective, randomized, controlled, multicenter study to evaluate the efficacy and safety of the designated Digital Application "OsteoCoach" for fall prevention, fracture prevention and enhanced mobility in older adults with osteoporosis

A prospective, randomized, controlled, multicenter study to evaluate the efficacy and safety of the designated Digital Application "OsteoCoach" for fall prevention, fracture prevention and enhanced mobility in older adults with osteoporosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00041144
Enrollment
182
Registered
2026-07-29
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Osteoporosis (ICD-10-GM M80.– Osteoporosis with pathological fracture

Interventions

Group 1: Intervention group: Standard care according to the DVO guidelines, plus use of the DiGA OsteoCoach (app-based, progressive balance and strength training) over a 12-week intervention period. G
supplemented by 6 sessions of physical therapy or 3 sessions of occupational therapy. After the second measurement point, the control group was offered access to the app.

Sponsors

Osteoconnect GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Medically documented osteoporosis (ICD-10-GM M80.– or M81.–); access to a smartphone or tablet with an internet connection; sufficient digital literacy; sufficient spoken and written German language skills; written informed consent.

Exclusion criteria

Exclusion criteria: Severe cognitive impairment preventing safe use; unstable cardiovascular disease; medical restriction against physical exertion; severe neurological dysfunction; other circumstances preventing use of the intervention.

Design outcomes

Primary

MeasureTime frame
Timed Up and Go Test (TUG), change from baseline (T0) to week 12 (T1). MCID 2.1 seconds. Chair Rise Test / 5-Times Sit-to-Stand (5xSTS), change from T0 to T1. MCID 2.5 seconds.

Secondary

MeasureTime frame
Falls Efficacy Scale International (FES-I), fear of falling. EQ-5D-5L, health-related quality of life. Adherence to the intervention (exploratory).

Countries

Germany

Contacts

Public ContactOliver Ebert

Osteopro München

oliver.ebert@osteopro.de+4908950222286

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026